MedTech

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.

The 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.

12345lexoro AutomationSelection of templatesData & Information from in-house systemsModifying & SupplementingPopulating chapters & tablesGenerating CERAutomatic copying & populating of data, texts & tables into the respective chapters of the Clinical Evaluation Report (CER):

1Selection of templates

Manual selection of the required CER template or CER chapter to be created

2Copying data & information from in-house systems

Software robot automatically copies relevant data, text & tables from in-house systems collected and created in advance by the Clinical Evaluation team

3Data preparation & supplementation

With the help of Natural Language Processing, necessary text or text elements are prepared, supplemented & analyzed - e.g., adaptation of tenses (present/future tense in past tense) and replacement of codes by the final terminology in the text

4Populating the templates or tables with relevant data

Fully automatic populating of the defined templates & tables with relevant data in the designated chapters - e.g., Summaries, Clinical Data and Review, Performance and Safety, etc.

5Generation & Export

Finally generation & export of report with filled tables for further manual processing & review

The benefits for the customer

100% error-free RPA technology combined with AI-supported processes leads to a standardized CER-generation workflow
  • Automatic Clinical Evaluation Report generation with data preparation – approx. 70% time saving
  • 100% error-free RPA technology with support of AI – individually tailored to you
  • Standardization of the workflow – MDR- and FDA-compliant creation of Clinical Evaluation Reports
  • 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

4.000 h / 300.000 €
Reduction in work performed per year. Total up to 3,0 FTE at 70% PQ

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.

Your contact person

Michael Fischbäck

Business Development Consultant

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