Pharmaceutical

Automated creation of Clinical Study Reports

For one of the world’s leading research-driven pharmaceutical companies with 130 years of experience lexoro automated the creation of clinical study reports (CSR). The Intelligent Automation contained 25.000 pages of medical writing, automated copying & filling of data, text and tables into the respective chapters from the Clinical Study Protocol (CSP) into the Clinical Study Report (CSR). Intelligent Automation of lexoro has freed the experts from many small tasks with little requirement and in addition, tables can be analyzed using Data Science and descriptive texts can be written using NLG.

The challenge

The manual creation of each clinical study with similar parts did mean a very high time expenditur for highly-qualified employees. For each clinical study a document with similar parts must be created. lexoros challenge: An Intelligent Automation of the conversion of data, text and tables into the respective chapters from the Clinical Study Protocol (CSP) into the Clinical Study Report (CSR). 100% error-free.

The problem

  • very high time expenditure
  • manual compilation of all relevant information from the Clinical Study Protocols
  • text and table generation of Clinical Study Reports
  • for each clinical study a document with similar parts must be created
  • Filling relevant content into proper chapters and tables

Customer

Our customer is one of the world’s leading research-driven pharmaceutical companies with 130 years of experience. With over 50.000 employees, the company does have a research and production network around the globe.

The solution: Intelligent Automation of CSR generation

For the automated generation of Clinical Study Reports, lexoro has automated the conversion of relevant information from Clinical Study Protocols to Clinical Study reports.

Thanks to the RPA, NLP and NLG technology implemented by lexoro, the client could benefit from time saving or automation level of about 70% and top experts can focus on other topics.

The process

Using Robotic Process Automation RPA technology a software robot automatically copies the relevant data, texts and tables from the protocol and in-house systems. Using Natural Language Processing (NLP), necessary texts or text elements are modified and rewritten, e.g., tenses (present/future tense in past tense) are adapted and drug codes with the final terminology in the text are replaced. Relevant tables are automatically evaluated & summarized for the respective chapter. Based on the contents of the tables, appropriate descriptive texts can be generated using Natural Language Generation (NLG). Finally the Clinical Study Report with populated tables for further manual processing and adjustment is generated and exported.

12345lexoro AutomationChoose template or chapterCreation of data basis (upload or collect)Formatting and AggregationTransfer, Filling and PopulationPreview and ExportDocument Generation for Clinical Study Reports from Clinical Study Protocol

1Choose template or chapter

Manual selection of the required template or chapter to be processed or generated.

2Creation of data basis (upload or collect)

Automated collecting and copying of relevant raw data, text, and tables from the Clinical Study Protocol and in-house systems.

3Formatting and Aggregation

Extraction, preparation, editing, and formatting of data, text, and tables for the CSR chapters - this includes adjusting tenses (present/future tense in past tense), replacing drug codes, or text generation for table descriptions.

4Transfer, Filling and Population

Final filling, population, and generation as well as export of the report with completed text segments and chapters

5Preview and Export

Lastly, the Clinical Study Report is generated & exported for further processing and review.

The benefits for the customer

Reduction of lengthy data transfer processes and increase of quality standards through 100% error-free RPA technology
  • Enormous reduction of lead time for a process that always runs the same way
  • Automated document preparation and generation
  • 100% error-free & robust Robotic Process Automation technology
  • Relieve and empower employees by saving time – better analysis possible
  • Fast solution development according to your needs – directly measurable ROI

The savings potential achieved

4200 h / 320.000 €
Reduction in work performed per year. Total up to 3,5 FTE at 50% 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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