Automated generation of Overviews and Summaries for CTD Module 2

Intelligent Automation is the key driver that not only accelerates the creation and generation of CTD Module 2 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


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.

The 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 – 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.

12345lexoro AutomationSelection of templatesCopying data &information fromin-house systems& textsData preparation & SupplementationFilling of thetemplate or thetables with therelevant dataGeneration ofthe summary orchapterAutomated copying & filling of relevant data, texts & tables into the associatedOverviews & Summaries of the Common Technical Document Module 2:

1Selection of the template

Manual selection of the required overview or summary template or CTD chapter to be created

2Copying data & information from in-house systems & texts

Software robot automatically copies the relevant data, texts & tables from internal company systems, which were collected and created in advance, e.g., through clinical studies

3Data preparation & supplementation

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

4Filling of the template or the tables with the relevant data

Fully automatic filling of the defined templates & tables with relevant data in the designated chapters - e.g. Quality & Clinical Summary, Non-clinical & Clinical Overview, etc.

5Generation of the summary or chapter

Final generation & export of the summary or chapter with completed text blocks & 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 CTD-generation workflow
  • 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

3.800 h / 280.000 €
Reduction in work performed per year. Total up to 2,5 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
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.

Your contact person

Michael Fischbäck

Business Development Consultant

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