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Benefits for our customers
- Reduction of costs
- Increase of quality
- Relief of employees
- Experts with focus on their activities
- Standardization of processes
- Increase in productivity
Intelligent Automation for Medical Device Registration Workflows
Regulatory or Clinical Affairs. Quality Management and Assurance. Product Safety, Risk Management and Post Market Surveillance. All these departments and competences have to work hand in hand when it comes to the registration process for medical devices and products. Within the medical device industry and other regulated industries it is incredibly important to document, report, and monitor everything that is going on and happening during a product life cycle. Intelligent Automation supports this entire life cycle in documentation and reporting with powerful components and technologies. Often achieving an automation level of 70%.
lexoro has been developing and delivering successful solutions for well-known medical device companies for over 20 years, accelerating their registration and regulatory workflows in various fields. Read more about our solutions here.
The challenge
With massive amounts of data that need to be collected, screened, analyzed, and subsequently processed and reported, manual tasks that require human time and attention are an enormous challenge for departments dealing with registration matters. Standard tasks like document generation, data collection, text and table transfer, or formatting pose a big problem – including the human error factor and the spending of valuable time and resources in already tight timeframes. Due to constantly higher hurdles for registration, approval, surveillance, and assessment due to the MDR and FDA in diverse countries, these highly standard-based tasks hinder the whole workflow.
The problem
- Highly qualified employees spending valuable time processing large amounts of data
- Tedious data and text processing in various documents and reports
- Recurring updating and transfer tasks for several product groups and drugs
- Copy & Paste tasks, Data collection in diverse systems and databases, formatting and editing
- Everything with viable, relevant, and compliant data
Customer
Our customers are broadly positioned, often with the same challenges of quality, flexibility, speed, and compliance. Reaching from globally active medical device and pharmaceutical enterprises, to medium-sized companies, to medical device service providers. All these customers trust in intelligent solutions powered by lexoro Automation with innovative approaches to accelerate and support tedious manual processes while delivering great results.
The solutions:
Intelligent Automation for Medical Device Registration Workflows
lexoro’s approach to automating these processes is based on Robotic Process Automation (RPA). Here, manual & tedious activities are learned and automated by so-called software robots. . Especially the „collection“ of information from different databases & operating systems and the populating & creation of documents and reports. The starting point is the manual selection of the necessary template and its parameters. Here, relevant information and key data are determined, such as the document type to be created and its areas, chapters & sections. Once these basic requirements have been determined, automation can begin.
Our Big Plus: Individual and customer-specific solutions for your special requirements and needs. Whether special formats, templates, systems, or databases, the customized solutions can accommodate just about anything.
The process
An overwhelming part within medical device deparrtments is spent on documentation and reporting with regulations and requirements becoming more complex including more and more data each year, making things even more complicated. With our Intelligent Automation solutions we focus on fast, precise, and efficient support for your processes. Our most successful and powerful solutions include Clinical Evaluation Plans, Clinical Evaluation Reports, and SSCP, PMS- or PMCF-Plan with diverse modules and chapters.
The used core components are adaptable for other types of documents and dossiers in the registration lifecycle – including data processing, formatting, transfer, population, export, etc. lexoro’s Intelligent Automation takes advantage of these challenges, releasing resources for your top experts.
1Technical Documentation
- Technical Documentation and in-house systems serve as starting point and data basis for the creation and generation of further documents and reports.
2Clinical Evaluation Plan (CEP)
- Automated data transfer and population of Clinical Study Plans. Text and data is collected from the technical documentation or in-house systems to create and fill the CEP.
3Clinical Evaluation Report (CER)
- As with the Clinical Study Plan, data, text, and tables can be transferred automatically from the CEP to the Clinical Evaluation Report (CER). Including relevant chapters and text segments with formatting and aggregation.
4SSCP and PMS- or PMCF-Plan
- Intelligent Automation for registration documents like SSCP, PMS- or PMCF-Plan. The same core components as used above can be adapted here to automatically extract, prepare, edit, and format data, text, and tables for the various templates and chapters.
The benefits for the customer
- Reduction of processing time: only approx. 25-30% have to be created and processed manually
- 100% error-free RPA technology with the support of AI – individually tailored to you
- Development of individual modules – you can design and determine special requirements
- Standardization of the workflow – MDR- and FDA-compliant creation of regulation documents
- Web-based Report & Document Generation. Secure data processing. Ready to use in 4-6 weeks
The savings potential achieved
Have your savings potential calculated now!
Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP, NLG
and Machine Learning and learn how much you can save with the innovative automation of your workflows and processes.
Automated generation of AMNOG Dossiers
Intelligent Automation is the key driver that not only accelerates the creation and generation of AMNOG Dossiers for one of our globally active pharmaceutical customers. By automating tedious and yet highly standardizable tasks, the overall AMNOG process has taken a significant leap. All of this with classic automation in the form of Robotic Process Automation to transfer data and text to subsequently populate and fill the desired AMNOG Dossiers. lexoro´s degree of automation: about 70% for document creation and generation.
The challenge
In many regulated industries, the approval process for products, drugs or substances is very tedious. Especially in the Pharmaceutical area, AMNOG provides physicians with information about the benefits and possible harm of new drugs before prescribing them to patients, creating a level of transparency. In order to precisely document the benefit assessment and to ultimately be able to properly evaluate the assessment, the AMNOG Dossier with 5 different modules is compiled by the Pharmaceutical manufacturer – all determined by the G-BA.
The problem
- Very high time expenditure with enormous scope of work
- Manual collection, modification and distribution of information, text elements, tables from various systems
- Time-consuming copy & paste tasks, formatting & editing, as well as compilation of different modules
- Populating relevant information into templates for the AMNOG Dossier with its several modules
Customer
Being globally active for several decades, our customer is one of the leading pharmaceutical companies with German origin. The company researches and creates life-changing products in various fields and areas and therefore has the ambition to pursue regulatory obligations in the best possible manner.
Industry
PharmaceuticalThe solution: Intelligent Automation for the creation and generation of AMNOG Dossiers
Intelligent Automation is the combination of classic automation (RPA) and Artificial Intelligence components and technologies like Natural Language Processing or Machine Learning. lexoro has optimized these technologies to automatically create and generate AMNOG Dossiers. Where there was tedious and time-consuming standard tasks before – now the lexoro technology automatically copies, populates data, text and tables to intelligently create AMNOG Dossiers with relevant text segments and chapters in no time.
Due to this next-level approach, the customer saves 70% of time in data collection and preparation workflows. Plus: the newly standardized process enables the company´s experts to leave routine tasks behind and concentrate on highly complex analyses and other value-adding activities. All in all a future-proof process to create products that really help people.
The process
After initially choosing or selecting a template or chapter for the AMNOG Dossier process manually, the Intelligent Automation process starts. From a data basis – that can be either uploaded or collected automatically – software robots are able to format, edit, compile, aggregate and generate text sections, segments, or whole chapters. These segments are then used to finally generate the dossier. The last step offers an export in any format for futher processing.
1Choose template or chapter
2Creation of data basis (upload or collect)
3Formatting and Aggregation
4Transfer, Filling and Population
5Preview and Export
The benefits for the customer
- Automatic AMNOG Dossier generation with data preparation – approx. 70% time saving
- 100% error-free RPA technology with support of AI – individually tailored to you
- Standardization of workflow – EMA- and FDA-compliant creation of dossier chapters and text segments
- Problem-free integration of the automation solution into your existing system landscape
- Fast solution development according to your needs & wishes – directly measurable ROI
The savings potential achieved
Have your savings potential calculated now!
Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP
and Machine Learning and learn how to accelerate AMNOG Dossiers and how much you can save with the innovative automation of your workflows and processes.
The challenge
With massive amounts of data that need to be collected, screened, analyzed, and subsequently processed and reported, manual tasks that require human time and attention are an enormous challenge for departments dealing with registration matters. Standard tasks like document generation, data collection, text and table transfer, or formatting pose a big problem – including the human error factor and the spending of valuable time and resources in already tight timeframes. Due to constantly higher hurdles for registration, approval, surveillance, and assessment due to the MDR and FDA in diverse countries, these highly standard-based tasks hinder the whole workflow.
The problem
- Highly qualified employees spending valuable time processing large amounts of data
- Tedious data and text processing in various documents and reports
- Recurring updating and transfer tasks for several product groups and drugs
- Copy & Paste tasks, Data collection in diverse systems and databases, formatting and editing
- Everything with viable, relevant, and compliant data
Customer
Our customers are broadly positioned, often with the same challenges of quality, flexibility, speed, and compliance. Reaching from globally active medical device and pharmaceutical enterprises, to medium-sized companies, to medical device service providers. All these customers trust in intelligent solutions powered by lexoro Automation with innovative approaches to accelerate and support tedious manual processes while delivering great results.
The solutions:
Intelligent Automation for Medical Device Registration Workflows
lexoro’s approach to automating these processes is based on Robotic Process Automation (RPA). Here, manual & tedious activities are learned and automated by so-called software robots. . Especially the „collection“ of information from different databases & operating systems and the populating & creation of documents and reports. The starting point is the manual selection of the necessary template and its parameters. Here, relevant information and key data are determined, such as the document type to be created and its areas, chapters & sections. Once these basic requirements have been determined, automation can begin.
Our Big Plus: Individual and customer-specific solutions for your special requirements and needs. Whether special formats, templates, systems, or databases, the customized solutions can accommodate just about anything.
The process
An overwhelming part within medical device deparrtments is spent on documentation and reporting with regulations and requirements becoming more complex including more and more data each year, making things even more complicated. With our Intelligent Automation solutions we focus on fast, precise, and efficient support for your processes. Our most successful and powerful solutions include Clinical Evaluation Plans, Clinical Evaluation Reports, and SSCP, PMS- or PMCF-Plan with diverse modules and chapters.
The used core components are adaptable for other types of documents and dossiers in the registration lifecycle – including data processing, formatting, transfer, population, export, etc. lexoro’s Intelligent Automation takes advantage of these challenges, releasing resources for your top experts.
1Technical Documentation
- Technical Documentation and in-house systems serve as starting point and data basis for the creation and generation of further documents and reports.
2Clinical Evaluation Plan (CEP)
- Automated data transfer and population of Clinical Study Plans. Text and data is collected from the technical documentation or in-house systems to create and fill the CEP.
3Clinical Evaluation Report (CER)
- As with the Clinical Study Plan, data, text, and tables can be transferred automatically from the CEP to the Clinical Evaluation Report (CER). Including relevant chapters and text segments with formatting and aggregation.
4SSCP and PMS- or PMCF-Plan
- Intelligent Automation for registration documents like SSCP, PMS- or PMCF-Plan. The same core components as used above can be adapted here to automatically extract, prepare, edit, and format data, text, and tables for the various templates and chapters.
The benefits for the customer
- Reduction of processing time: only approx. 25-30% have to be created and processed manually
- 100% error-free RPA technology with the support of AI – individually tailored to you
- Development of individual modules – you can design and determine special requirements
- Standardization of the workflow – MDR- and FDA-compliant creation of regulation documents
- Web-based Report & Document Generation. Secure data processing. Ready to use in 4-6 weeks
The savings potential achieved
Have your savings potential calculated now!
Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP, NLG
and Machine Learning and learn how much you can save with the innovative automation of your workflows and processes.
Intelligent Automation for Pharmaceutical Registration Workflows
Regulatory, Clinical, or Medical Affairs. Drug or Product Safety. Quality Management and Assurance. Risk Management and Post Market Surveillance. All these departments and competences have to work hand in hand when it comes to the registration process for drugs and medicines. Within the pharmaceutical industry and other regulated industries it is incredibly important to document, report, and monitor everything that is going on and happening during a drug life cycle. Intelligent Automation supports this entire life cycle in documentation and reporting with powerful components and technologies. Often achieving an automation level of 70%.
lexoro has been developing and delivering successful solutions for well-known pharmaceutical companies for over 20 years, accelerating their registration and regulatory workflows in various fields. Read more about our solutions here.
The challenge
With massive amounts of data that need to be collected, screened, analyzed, and subsequently processed and reported, manual tasks that require human time and attention are an enormous challenge for departments dealing with registration matters. Standard tasks like document generation, data collection, text and table transfer, or formatting pose a big problem – including the human error factor and the spending of valuable time and resources in already tight timeframes. Due to constantly higher hurdles for drug approval and assessment in diverse countries, these highly standard-based tasks hinder the whole workflow.
The problem
- Highly qualified employees spending valuable time processing large amounts of data
- Tedious data and text processing in various documents and reports
- Recurring updating and transfer tasks for several product groups and drugs
- Copy & Paste tasks, Data collection in diverse systems and databases, formatting and editing
- Everything with viable, relevant, and compliant data
Customer
Our customers are broadly positioned, often with the same challenges of quality, flexibility, speed, and compliance. Reaching from globally active pharmaceutical enterprises, to medium-sized companies, to Clinical Research Organizations. All these customers trust in intelligent solutions powered by lexoro Automation with innovative approaches to accelerate and support tedious manual processes while delivering great results.
The solutions:
Intelligent Automation for Pharmaceutical Registration Workflows
lexoro’s approach to automating these processes is based on Robotic Process Automation (RPA). Here, manual & tedious activities are learned and automated by so-called software robots. . Especially the „collection“ of information from different databases & operating systems and the populating & creation of documents and reports. The starting point is the manual selection of the necessary template and its parameters. Here, relevant information and key data are determined, such as the document type to be created and its areas, chapters & sections. Once these basic requirements have been determined, automation can begin.
Our Big Plus: Individual and customer-specific solutions for your special requirements and needs. Whether special formats, templates, systems, or databases, the customized solutions can accommodate just about anything.
The process
An overwhelming part within pharmaceutical deparrtments is spent on documentation and reporting with regulations and requirements becoming more complex including more and more data each year, making things even more complicated. With our Intelligent Automation solutions we focus on fast, precise, and efficient support for your processes. Our most successful and powerful solutions include Clinical Study or Trial Protocols, Clinical Study or Trial Reports, and Common Technical Documents with diverse modules and chapters.
The used core components are adaptable for other types of documents and dossiers in the registration lifecycle – including data processing, formatting, transfer, population, export, etc. lexoro’s Intelligent Automation takes advantage of these challenges, releasing resources for your top experts.
1Technical Documentation
- Technical Documentation and in-house systems serve as starting point and data basis for the creation and generation of further documents and reports.
2Clinical Study or Trial Protocol (CSP or CTP)
- Automated data transfer and population of Clinical Study Protocols (CSP/CTP). Text and data is collected from the technical documentation or in-house systems to create and fill the CSP / CTP.
3Clinical Study or Trial Report (CSR or CTR)
- As with the Clinical Study Protocol, Data, text, and tables can be transferred automatically from the CSP to the Clinical Study Report (CSR/CTR). Including relevant chapters and text segments with formatting and aggregation.
4Common Technical Document (CTD) and Modules
- Intelligent Automation for registration documents and modules within the Common Technical Document and its dossiers. The same core components as used above can be adapted here to automatically extract, prepare, edit, and format data, text, and tables for the various CTD modules.
The benefits for the customer
- Reduction of processing time: only approx. 20-25% have to be created and processed manually
- 100% error-free RPA technology with the support of AI – individually tailored to you
- Development of individual modules – you can design and determine special requirements
- Standardization of the workflow – EMA- and FDA-compliant creation of regulation documents
- Web-based Report & Document Generation. Secure data processing. Ready to use in 4-6 weeks
The savings potential achieved
Have your savings potential calculated now!
Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP, NLG
and Machine Learning and learn how much you can save with the innovative automation of your workflows and processes.
The challenge
With massive amounts of data that need to be collected, screened, analyzed, and subsequently processed and reported, manual tasks that require human time and attention are an enormous challenge for departments dealing with registration matters. Standard tasks like document generation, data collection, text and table transfer, or formatting pose a big problem – including the human error factor and the spending of valuable time and resources in already tight timeframes. Due to constantly higher hurdles for registration, approval, surveillance, and assessment due to the MDR and FDA in diverse countries, these highly standard-based tasks hinder the whole workflow.
The problem
- Highly qualified employees spending valuable time processing large amounts of data
- Tedious data and text processing in various documents and reports
- Recurring updating and transfer tasks for several product groups and drugs
- Copy & Paste tasks, Data collection in diverse systems and databases, formatting and editing
- Everything with viable, relevant, and compliant data
Customer
Our customers are broadly positioned, often with the same challenges of quality, flexibility, speed, and compliance. Reaching from globally active medical device and pharmaceutical enterprises, to medium-sized companies, to medical device service providers. All these customers trust in intelligent solutions powered by lexoro Automation with innovative approaches to accelerate and support tedious manual processes while delivering great results.
The solutions:
Intelligent Automation for Medical Device Registration Workflows
lexoro’s approach to automating these processes is based on Robotic Process Automation (RPA). Here, manual & tedious activities are learned and automated by so-called software robots. . Especially the „collection“ of information from different databases & operating systems and the populating & creation of documents and reports. The starting point is the manual selection of the necessary template and its parameters. Here, relevant information and key data are determined, such as the document type to be created and its areas, chapters & sections. Once these basic requirements have been determined, automation can begin.
Our Big Plus: Individual and customer-specific solutions for your special requirements and needs. Whether special formats, templates, systems, or databases, the customized solutions can accommodate just about anything.
The process
An overwhelming part within medical device deparrtments is spent on documentation and reporting with regulations and requirements becoming more complex including more and more data each year, making things even more complicated. With our Intelligent Automation solutions we focus on fast, precise, and efficient support for your processes. Our most successful and powerful solutions include Clinical Evaluation Plans, Clinical Evaluation Reports, and SSCP, PMS- or PMCF-Plan with diverse modules and chapters.
The used core components are adaptable for other types of documents and dossiers in the registration lifecycle – including data processing, formatting, transfer, population, export, etc. lexoro’s Intelligent Automation takes advantage of these challenges, releasing resources for your top experts.
1Technical Documentation
- Technical Documentation and in-house systems serve as starting point and data basis for the creation and generation of further documents and reports.
2Clinical Evaluation Plan (CEP)
- Automated data transfer and population of Clinical Study Plans. Text and data is collected from the technical documentation or in-house systems to create and fill the CEP.
3Clinical Evaluation Report (CER)
- As with the Clinical Study Plan, data, text, and tables can be transferred automatically from the CEP to the Clinical Evaluation Report (CER). Including relevant chapters and text segments with formatting and aggregation.
4SSCP and PMS- or PMCF-Plan
- Intelligent Automation for registration documents like SSCP, PMS- or PMCF-Plan. The same core components as used above can be adapted here to automatically extract, prepare, edit, and format data, text, and tables for the various templates and chapters.
The benefits for the customer
- Reduction of processing time: only approx. 25-30% have to be created and processed manually
- 100% error-free RPA technology with the support of AI – individually tailored to you
- Development of individual modules – you can design and determine special requirements
- Standardization of the workflow – MDR- and FDA-compliant creation of regulation documents
- Web-based Report & Document Generation. Secure data processing. Ready to use in 4-6 weeks
The savings potential achieved
Have your savings potential calculated now!
Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP, NLG
and Machine Learning and learn how much you can save with the innovative automation of your workflows and processes.
Automated population & creation of the Summary of Safety and Clinical Performance
The Medical Device Regulation (MDR) has brought several obligations and requirements regarding reporting, safety, and other risk-preventive actions. These processes and the effort that comes with them, has left a lot of companies struggling with the regulatory workflows. The Intelligent Automation solution by lexoro helps our clients in the medical device sector to accelerate the preparation, the population and the generation of chapters and sections within the Summary of Safety and Clinical Performance (SSCP). This way, the workload for these summary reports – obligatory for Class III and implantable devices – can be reduced significantly. lexoro´s big performance-plus: a degree of automation of about 70%.
The challenge
Class III and implantable devices usually mean a higher level of risk for the patient. Therefore, the Medical Device Regulation has seen the necessity for a routine summary to display clinical data regarding the safety and performance of such devices. While the Post Market Surveillance process is going on regularly, the SSCP has to be updated once a year as well. The challenge for manufacturers lies in the additional effort that has to be put into this short summary – collecting clinical data, updating outdated information, choosing an appropriate language that is readable for the general public and making it accessible after several checks by Notified Bodies. And all this in accordance with the current requirements of the MDR.
The problem
- High time expenditure for a routine-based workload
- Manual collection, copying, distribution, and updating of information, text elements, tables from various systems
- Time-consuming copy & paste tasks for several chapters and sections
- Populating relevant information into templates for the SSCP
Customer
Being a globally active company within the medical device sector and a portfolio also includes the high-risk implants and Class III devices, our customer wanted to accelerate the tedious work for the preparation of SSCPs. This was only one step in the company´s journey to regulatory excellence under new MDR requirements where lexoro is a key partner.
The solution: Intelligent Automation for Summary of Safety and Clinical Performance (Class III & Implants)
For the intelligent solution to accelerate the SSCP workflow, lexoro has leveraged the power of RPA and NLP and consequently restructured the preparation and population. This way, lexoro can enable and inspire a company´s top regulatory experts by either completely removing or semi-automating routine tasks. Typically, these tasks would include the likes of copy & paste, data collection, and content population. With lexoro´s innovative Intelligent Automation technology, regulatory departments can save up to 70%. And by introducing the fully flexible and customized solution into your system environment, the transition runs almost seamlessly.
The process
The initial and only manual step includes the selection of a template for the summary or the report to be created. In the following, software robots automatically search through internal systems to collect relevant information and data. These can be textual, tabular, numeric or other data that fits the relevancy criteria for the respective template or chapter. After the collection of the data basis is completed successfully, it is possible to prepare, format and supplement the data using Natural Language Processing. In the final step, the lexoro solution processes the fully automatic population of the defined templates & tables with relevant data into the designated summary chapters and exports the finalized document in a format of choice.
1Choose template or chapter
2Creation of data basis (upload or collect)
3Formatting and Aggregation
4Transfer, Filling and Population
5Preview and Export
The benefits for the customer
- Automated support for preparation & creation of SSCPs – approx. 70% time saving
- 100% error-free RPA technology with support of AI – individual solution for your needs
- Standardization of the workflow – MDR-compliant creation of chapters and subsections
- Problem-free integration of the automation solution into your existing system landscape
- Fast support and thus relief for your top experts – directly measurable ROI
The savings potential achieved
Have your savings potential calculated now!
Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP
and Machine Learning and learn how to accelerate Overviews and Summaries and how much you can save with the innovative automation of your workflows and processes.
The challenge
With massive amounts of data that need to be collected, screened, analyzed, and subsequently processed and reported, manual tasks that require human time and attention are an enormous challenge for departments dealing with registration matters. Standard tasks like document generation, data collection, text and table transfer, or formatting pose a big problem – including the human error factor and the spending of valuable time and resources in already tight timeframes. Due to constantly higher hurdles for registration, approval, surveillance, and assessment due to the MDR and FDA in diverse countries, these highly standard-based tasks hinder the whole workflow.
The problem
- Highly qualified employees spending valuable time processing large amounts of data
- Tedious data and text processing in various documents and reports
- Recurring updating and transfer tasks for several product groups and drugs
- Copy & Paste tasks, Data collection in diverse systems and databases, formatting and editing
- Everything with viable, relevant, and compliant data
Customer
Our customers are broadly positioned, often with the same challenges of quality, flexibility, speed, and compliance. Reaching from globally active medical device and pharmaceutical enterprises, to medium-sized companies, to medical device service providers. All these customers trust in intelligent solutions powered by lexoro Automation with innovative approaches to accelerate and support tedious manual processes while delivering great results.
The solutions:
Intelligent Automation for Medical Device Registration Workflows
lexoro’s approach to automating these processes is based on Robotic Process Automation (RPA). Here, manual & tedious activities are learned and automated by so-called software robots. . Especially the „collection“ of information from different databases & operating systems and the populating & creation of documents and reports. The starting point is the manual selection of the necessary template and its parameters. Here, relevant information and key data are determined, such as the document type to be created and its areas, chapters & sections. Once these basic requirements have been determined, automation can begin.
Our Big Plus: Individual and customer-specific solutions for your special requirements and needs. Whether special formats, templates, systems, or databases, the customized solutions can accommodate just about anything.
The process
An overwhelming part within medical device deparrtments is spent on documentation and reporting with regulations and requirements becoming more complex including more and more data each year, making things even more complicated. With our Intelligent Automation solutions we focus on fast, precise, and efficient support for your processes. Our most successful and powerful solutions include Clinical Evaluation Plans, Clinical Evaluation Reports, and SSCP, PMS- or PMCF-Plan with diverse modules and chapters.
The used core components are adaptable for other types of documents and dossiers in the registration lifecycle – including data processing, formatting, transfer, population, export, etc. lexoro’s Intelligent Automation takes advantage of these challenges, releasing resources for your top experts.
1Technical Documentation
- Technical Documentation and in-house systems serve as starting point and data basis for the creation and generation of further documents and reports.
2Clinical Evaluation Plan (CEP)
- Automated data transfer and population of Clinical Study Plans. Text and data is collected from the technical documentation or in-house systems to create and fill the CEP.
3Clinical Evaluation Report (CER)
- As with the Clinical Study Plan, data, text, and tables can be transferred automatically from the CEP to the Clinical Evaluation Report (CER). Including relevant chapters and text segments with formatting and aggregation.
4SSCP and PMS- or PMCF-Plan
- Intelligent Automation for registration documents like SSCP, PMS- or PMCF-Plan. The same core components as used above can be adapted here to automatically extract, prepare, edit, and format data, text, and tables for the various templates and chapters.
The benefits for the customer
- Reduction of processing time: only approx. 25-30% have to be created and processed manually
- 100% error-free RPA technology with the support of AI – individually tailored to you
- Development of individual modules – you can design and determine special requirements
- Standardization of the workflow – MDR- and FDA-compliant creation of regulation documents
- Web-based Report & Document Generation. Secure data processing. Ready to use in 4-6 weeks
The savings potential achieved
Have your savings potential calculated now!
Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP, NLG
and Machine Learning and learn how much you can save with the innovative automation of your workflows and processes.
Intelligent Automation for Benefit Assessment & AMNOG
For a leading European company providing medicines and care, lexoro developed a solution to automate the benefit assessment for pharmaceuticals. By using Intelligent Automation to search databases and evaluate the results, this solution accelerates the whole assessment workflow. The benefits: The intelligent solution serves the customer significant time savings for tedious standard routines as well as automatic output of the results in a standardized list. In conclusion, the database search and evaluation or assessment process is highly accelerated by focussing on relieving the top experts.
The challenge
For Benefit Assessment, Cost-effectiveness and the AMNOG procedure of produced medicines, various databases must be searched regularly for new information. This involves a very timeintensive information acquisition process by regularly querying defined search criteria and strategies and then displaying the results in a list. Due to constantly higher hurdles for drug approval and assessment in diverse countries, these highly standard-based tasks hinder the whole workflow.
The problem
- Higher hurdles to drug approval with several different requirements for diverse countries
- Significant time investment by highly qualified employees
- Repetitive serial process for database query
- No automation of a highly standards-based process
Customer
Our customer is a leading European provider of medicines and care. Working closely together with a Clinical Research Organization (CRO), the company needs to gather an immense amount of information over a wide range of products and drugs in order to ensure the benefits and thus guarantee the drug approvals.
Industry
PharmaceuticalThe solution:
Intelligent Automation with lexoro
To standardize and accelerate the literature search & review for benefit assessments, lexoro has automated the extraction of information from database queries with the help of Robotic Process Automation (RPA) & Natural Language Processing. With the scalable power of the lexoro crawler, it is now possible to gather relevant information in every wanted database in literally no time. In addition to that and a huge quality booster: the RPA-driven technology works 100% error-free.
The process
An individualized & flexible search strategy in combination with the autonomy of the lexoro solution delivers amazing results. The addition of several databases (like BfArM, FDA, MAUDE, ANSM / AEMPS or other platforms combining several databases) according to your needs is uncomplicated. With the help of NLP the hits are evaluated according to relevance and automatically exported in a standardized list for further use. A serial and very time-consuming database query has been transformed into an automated process that enables companies to optimize and accelerate their benefit assessment and guarantees significant time savings for the company´s top experts.
1Definition search strategy & databases
2Information acquisition in databases
- High frequency & time saving
3Deduplicate & merging the results
- Replacing tedious standard tasks & optimizing result quality
4Evaluation & classification by relevance
- Standardization & precise exclusion criteria
5Export the findings & results
- 100% error-free RPA technology
The benefits for the customer
- Reduction of processing time: only approx. 20-25% of the results have to be checked manually
- Automated database search with results & outcomes in real time
- 100% error-free RPA technology with the support of AI – individually tailored to you
- Relieve and empower employees by saving time – better analysis possible
- Standardization of literature research & the creation of benefit assessment dossiers
The savings potential achieved
Have your savings potential calculated now!
Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP, NLG
and Machine Learning and learn how much you can save with the innovative automation of your workflows and processes.
The challenge
With massive amounts of data that need to be collected, screened, analyzed, and subsequently processed and reported, manual tasks that require human time and attention are an enormous challenge for departments dealing with registration matters. Standard tasks like document generation, data collection, text and table transfer, or formatting pose a big problem – including the human error factor and the spending of valuable time and resources in already tight timeframes. Due to constantly higher hurdles for registration, approval, surveillance, and assessment due to the MDR and FDA in diverse countries, these highly standard-based tasks hinder the whole workflow.
The problem
- Highly qualified employees spending valuable time processing large amounts of data
- Tedious data and text processing in various documents and reports
- Recurring updating and transfer tasks for several product groups and drugs
- Copy & Paste tasks, Data collection in diverse systems and databases, formatting and editing
- Everything with viable, relevant, and compliant data
Customer
Our customers are broadly positioned, often with the same challenges of quality, flexibility, speed, and compliance. Reaching from globally active medical device and pharmaceutical enterprises, to medium-sized companies, to medical device service providers. All these customers trust in intelligent solutions powered by lexoro Automation with innovative approaches to accelerate and support tedious manual processes while delivering great results.
The solutions:
Intelligent Automation for Medical Device Registration Workflows
lexoro’s approach to automating these processes is based on Robotic Process Automation (RPA). Here, manual & tedious activities are learned and automated by so-called software robots. . Especially the „collection“ of information from different databases & operating systems and the populating & creation of documents and reports. The starting point is the manual selection of the necessary template and its parameters. Here, relevant information and key data are determined, such as the document type to be created and its areas, chapters & sections. Once these basic requirements have been determined, automation can begin.
Our Big Plus: Individual and customer-specific solutions for your special requirements and needs. Whether special formats, templates, systems, or databases, the customized solutions can accommodate just about anything.
The process
An overwhelming part within medical device deparrtments is spent on documentation and reporting with regulations and requirements becoming more complex including more and more data each year, making things even more complicated. With our Intelligent Automation solutions we focus on fast, precise, and efficient support for your processes. Our most successful and powerful solutions include Clinical Evaluation Plans, Clinical Evaluation Reports, and SSCP, PMS- or PMCF-Plan with diverse modules and chapters.
The used core components are adaptable for other types of documents and dossiers in the registration lifecycle – including data processing, formatting, transfer, population, export, etc. lexoro’s Intelligent Automation takes advantage of these challenges, releasing resources for your top experts.
1Technical Documentation
- Technical Documentation and in-house systems serve as starting point and data basis for the creation and generation of further documents and reports.
2Clinical Evaluation Plan (CEP)
- Automated data transfer and population of Clinical Study Plans. Text and data is collected from the technical documentation or in-house systems to create and fill the CEP.
3Clinical Evaluation Report (CER)
- As with the Clinical Study Plan, data, text, and tables can be transferred automatically from the CEP to the Clinical Evaluation Report (CER). Including relevant chapters and text segments with formatting and aggregation.
4SSCP and PMS- or PMCF-Plan
- Intelligent Automation for registration documents like SSCP, PMS- or PMCF-Plan. The same core components as used above can be adapted here to automatically extract, prepare, edit, and format data, text, and tables for the various templates and chapters.
The benefits for the customer
- Reduction of processing time: only approx. 25-30% have to be created and processed manually
- 100% error-free RPA technology with the support of AI – individually tailored to you
- Development of individual modules – you can design and determine special requirements
- Standardization of the workflow – MDR- and FDA-compliant creation of regulation documents
- Web-based Report & Document Generation. Secure data processing. Ready to use in 4-6 weeks
The savings potential achieved
Have your savings potential calculated now!
Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP, NLG
and Machine Learning and learn how much you can save with the innovative automation of your workflows and processes.
Automated generation of Common Technical Documents and its Modules
Intelligent Automation is the key driver that not only accelerates the creation and generation of CTD Modules, Overviews and Summaries within a globally active pharmaceutical group. It also empowers the highly competent experts by automating tedious standard tasks and time-consuming copy & paste routines. This way, the generation of reports, documents and other mandatory parts of the Common Technical Document is taken to a new level with time savings and a degree of automation of about 70%.
The challenge
In many regulated industries, the approval process for products, drugs or substances is very tedious. But especially in the Pharmaceutical area – where people and humans are arguably affected by the product more than in any other industry – the registration process is a major assignment. Registration dossiers – like the Common Technical Document – often take up several thousand pages of reports, analyses and evaluations. All according to several special requirements and compliance factors of the EMA and FDA.
The problem
- Very high time expenditure with enormous scope of work
- Manual collection, modification and distribution of information, text elements, tables from various systems
- Time-consuming copy & paste tasks for several thousand pages
- Populating relevant information into templates for the CTD with its several modules
Customer
Our customer is one of the world’s leading healthcare and life science companies with over 70.000 employees in diverse sectors worldwide. The company researches and creates life-changing products in various fields and areas and therefore has the ambition to pursue regulatory obligations in the best possible manner.
Industry
PharmaceuticalThe solution: Intelligent Automation of CTD (Module 2) Overviews and Summaries
For the automated population, creation & generation of overviews and summaries for Common Technical Documents – especially Module 2 and 3 – lexoro has leveraged the power and possibilities of Intelligent Automation. RPA, NLP and NLG technology go hand in hand to create the optimal outcome for our customers. Where there was tedious and time-consuming standard tasks before – now the lexoro technology automatically copies, populates data, text and tables to intelligently create overviews and summaries in no time.
Due to this next-level approach, the customer saves 70% of time in data collection and preparation workflows. Plus: the newly standardized process enables the company´s experts to leave routine tasks behind and concentrate on highly complex analyses and other value-adding activities. All in all a future-proof process to create products that really help people.
The process
After manually selecting a fitting overview or summary template or a CTD-chapter for the intelligent populating process, software-robots collect various data and information from internal systems that fit the relevancy criteria for the respective template or chapter. The next step involves automated analysis of said collected data to modify the information – if necessary. After successfully connecting text and text elements with the designated parts in the template or chapters, the technology fully automatically fills these segments with the before collected data to finally generate the wanted summary or overview. The last step offers an export in any format for futher processing.
1Choose template or chapter
2Creation of data basis (upload or collect)
3Formatting and Aggregation
4Transfer, Filling and Population
5Preview and Export
The benefits for the customer
- Automatic CTD overview & summary generation with data preparation – approx. 70% time saving
- 100% error-free RPA technology with support of AI – individually tailored to you
- Standardization of workflow – EMA- and FDA-compliant creation of Module 2 chapters
- Problem-free integration of the automation solution into your existing system landscape
- Fast solution development according to your needs & wishes – directly measurable ROI
The savings potential achieved
Have your savings potential calculated now!
Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP
and Machine Learning and learn how to accelerate Overviews and Summaries and how much you can save with the innovative automation of your workflows and processes.
The challenge
With massive amounts of data that need to be collected, screened, analyzed, and subsequently processed and reported, manual tasks that require human time and attention are an enormous challenge for departments dealing with registration matters. Standard tasks like document generation, data collection, text and table transfer, or formatting pose a big problem – including the human error factor and the spending of valuable time and resources in already tight timeframes. Due to constantly higher hurdles for registration, approval, surveillance, and assessment due to the MDR and FDA in diverse countries, these highly standard-based tasks hinder the whole workflow.
The problem
- Highly qualified employees spending valuable time processing large amounts of data
- Tedious data and text processing in various documents and reports
- Recurring updating and transfer tasks for several product groups and drugs
- Copy & Paste tasks, Data collection in diverse systems and databases, formatting and editing
- Everything with viable, relevant, and compliant data
Customer
Our customers are broadly positioned, often with the same challenges of quality, flexibility, speed, and compliance. Reaching from globally active medical device and pharmaceutical enterprises, to medium-sized companies, to medical device service providers. All these customers trust in intelligent solutions powered by lexoro Automation with innovative approaches to accelerate and support tedious manual processes while delivering great results.
The solutions:
Intelligent Automation for Medical Device Registration Workflows
lexoro’s approach to automating these processes is based on Robotic Process Automation (RPA). Here, manual & tedious activities are learned and automated by so-called software robots. . Especially the „collection“ of information from different databases & operating systems and the populating & creation of documents and reports. The starting point is the manual selection of the necessary template and its parameters. Here, relevant information and key data are determined, such as the document type to be created and its areas, chapters & sections. Once these basic requirements have been determined, automation can begin.
Our Big Plus: Individual and customer-specific solutions for your special requirements and needs. Whether special formats, templates, systems, or databases, the customized solutions can accommodate just about anything.
The process
An overwhelming part within medical device deparrtments is spent on documentation and reporting with regulations and requirements becoming more complex including more and more data each year, making things even more complicated. With our Intelligent Automation solutions we focus on fast, precise, and efficient support for your processes. Our most successful and powerful solutions include Clinical Evaluation Plans, Clinical Evaluation Reports, and SSCP, PMS- or PMCF-Plan with diverse modules and chapters.
The used core components are adaptable for other types of documents and dossiers in the registration lifecycle – including data processing, formatting, transfer, population, export, etc. lexoro’s Intelligent Automation takes advantage of these challenges, releasing resources for your top experts.
1Technical Documentation
- Technical Documentation and in-house systems serve as starting point and data basis for the creation and generation of further documents and reports.
2Clinical Evaluation Plan (CEP)
- Automated data transfer and population of Clinical Study Plans. Text and data is collected from the technical documentation or in-house systems to create and fill the CEP.
3Clinical Evaluation Report (CER)
- As with the Clinical Study Plan, data, text, and tables can be transferred automatically from the CEP to the Clinical Evaluation Report (CER). Including relevant chapters and text segments with formatting and aggregation.
4SSCP and PMS- or PMCF-Plan
- Intelligent Automation for registration documents like SSCP, PMS- or PMCF-Plan. The same core components as used above can be adapted here to automatically extract, prepare, edit, and format data, text, and tables for the various templates and chapters.
The benefits for the customer
- Reduction of processing time: only approx. 25-30% have to be created and processed manually
- 100% error-free RPA technology with the support of AI – individually tailored to you
- Development of individual modules – you can design and determine special requirements
- Standardization of the workflow – MDR- and FDA-compliant creation of regulation documents
- Web-based Report & Document Generation. Secure data processing. Ready to use in 4-6 weeks
The savings potential achieved
Have your savings potential calculated now!
Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP, NLG
and Machine Learning and learn how much you can save with the innovative automation of your workflows and processes.
Automated creation of Clinical Evaluation Reports
For one of the world’s leading medical technology companies which offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine lexoro automated the creation of Clinical Evaluation Reports (CER). For our client we automated the creation of Clinical Evaluation Reports by copying, preparing & populating text & tables to speed up process cycles and tedious workflows using RPA and NLP technology. With the Intelligent Automation of the workflows we achieved a degree of automation and therefore time savings of about 70%.
The challenge
In medical device technology the Clinical Evaluation Report (CER) is a vital milestone for every device. As the clinical evaluation generates and provides necessary data and information for safety and performance, these outcomes must be recorded and maintained in the CER. This is where the challenge relies. There are a lot of summaries, tables, evaluations, conclusions and analyses that have to be created and collected from different sources. All according to several special requirements and compliance factors of the MDR and MEDDEV 2.7.1.
The problem
- Very high time expenditure
- Manual collection and evaluation of all relevant information from the Clinical Evaluation
- Time-consuming copy & paste tasks
- Populating relevant information into templates for CER
Customer
Our customer is one of the world’s leading healthcare companies with over 20.000 employees worldwide. The company researches and creates medical devices like orthopedic and surgical implants with also delivering fields like the neurotechnology and other surgical areas.
Industry
MedTechThe solution: Intelligent Automation of CER preparation & generation
For the automated generation and support of Clinical Evaluation Reports (CER), lexoro has combined the technologies on a modular level. RPA, NLP and NLG technology go hand in hand to create the optimal outcome for our customers. Now the copying, preparation & populating of texts, tables & templates for nearly all parts of the CER is automated and tedious workflows are accelerated.
Thanks to 100% error-free RPA technology combined with Artificial Intelligence the repetitive process of report generation is standardized and 100% error-free. The customer saves 70% of time concerning data preparation while top experts can focus on analyses and summaries (value-added activities) and thus increase the results and outcomes of the overall process.
The process
After manually selecting a CER-template or a CER-chapter for the intelligent populating process, software-robots crawl various in-house databases and systems to collect relevant data and information. In the next step these information are analyzed, modified if necessary and prepared for the next stages. After successfully connecting text and text elements with the designated parts in the template or chapters, the technology fully automatically fills these segments with the before collected data to finally generate e.g., summaries, clinical data and review, performance and safety, etc. The last step offers an export in any format for futher processing.