Can data drive documents and dossiers?

A major global pharmaceutical company wanted to check whether it was feasible to manage data in a database; where the data was used to auto-populate document templates and that the resulted documents ended up in regulatory dossiers. The solution should be able to cope with country-specific differences in data, documents and dossiers.

Overcome the differences in marketing authorizations impacting data, documents and dossiers

The main objectives were to overcome differences in the marketing authorizations impacting the the data, documents and dossiers, such as:
  1. identical pharmaceutical products in two countries, but differences in container (e.g. blister vs. bottle)
  2. identical pharmaceutical products, but differences in the level of detail provided (with or without supplier of the ingredients)
  3. identical pharmaceutical products, but a change in the color of the tablet in one country, but not in the other country

Change old habits and step away from paper processes and paper thinking

During the project we faced various challenges. Often what seemed obvious for one person, was not that obvious when looking across boundaries and from different perspectives. Most people had to step away from paper processes and paper thinking. ‘Why change habits as the current way of working has been applied for more than 25 years? While working on the project, it appeared that Structured Content Management required another type of authoring style. Tools cannot automate what is not structured or and if different personal preferences are applied. Currently data is captured in unstructured Word and PDF documents. The recipients read the information and adsorb the data they need.

Project description

Together with the customer, Qdossier defined which documents are most subject to change and where country-specific differences exist. Subsequently, the authoritative sources of truth were defined for the data to be reflected in the documents. We also had to collect country-specific requirements for the type of information and level of details to be provided per country. As a result, a few Module 3 documents were selected, including though not limited to P.1, P.5.1 and P.8.1.
While talking about the definition of a product, the team became aware that various people had different definitions of that. Even for the term to be used for a substance, multiple options were to be considered.
It also became clear that auto generation was possible for the examples we used, but linguistic issues arose like ‘a blue tablet’ vs. ‘an orange tablet’; ‘One blister is’ vs. ‘two blisters are’. Therefore, we decided to redo the document templates and transformed these from narratives to tabular formats. This solved more than just these grammar issues. We were also able to do translations, based of corresponding translations of the master data.
As far as the dossier outlines were concerned, the contextual metadata of a change request was able to create dossier outlines for the countries involved and for the company core dossier, reflecting any registration worldwide.
Based on this positive outcome we extended the feasibility study to address Product Information and various chapters in clinical study reports. Actually, it let the the same conclusions; namely factual information to be provided in tabular formats and needs for authoritative sources and controlled dictionaries.


Customer benefits

While working on this project, the customer became very aware of the need for master data. It was too bad that EMA did not pursue their IDMP deadline, because that would have forced the company to solve master data definitions and having controlled dictionaries. The company became also aware that the content and authoring styles of the documents that have been created in the past have been diverted over time. Reproducing formerly accepted documents by consistent structure and automation was not possible. However, the auto-population of well structured tabular formats that are compliant to ICH Q guidelines appeared well feasible. Even the automatic assembly and compilation of country-specific dossiers looked very good and appealing. But as became clear, reliable sources and electronic thinking are key to success.