Success story
Timely Scientific Evidence for Europe
Medical Affairs team of a mid-sized pharmaceutical company
Pharmaceutical industry and market access
Scientific evidence published in time to enter the European market
The Medical Affairs team of a pharmaceutical company needed to reinforce the clinical positioning of one of its products before various European evaluation committees.
The challenge was defined by the deadlines. The decision windows were already defined and the internal team did not have the time or the necessary resources to develop and publish a full systematic review before those key dates.
Current need
It was necessary generate strong and publishable scientific evidence within a very tight schedule, so that it could be available in time to support the clinical positioning of the product before European evaluators.
To do this, it was necessary to:
- Review the available scientific evidence.
- Identify potential gaps that could be relevant to the evaluation committees.
- Define a suitable research question.
- Develop a systematic review with meta-analysis following a rigorous methodology.
- Coordinate the publication based on strategic evaluation dates.
- Minimize the operational burden on the internal team.
How do we approach it?
From OMEDICS We organize the entire project based on key evaluation dates, handling both scientific development and the preparation and management of publications.
Our work included:
- Mapping of available scientific evidence and identification of potential gaps.
- Design of a systematic review with meta-analysis.
- Protocol registration in PROSPERO.
- Project development following the PRISMA methodology.
- Literature search, peer screening, data extraction, and quality assessment of evidence.
- Quantitative analysis and synthesis of results.
- Publication scheduling based on evaluation windows.
- Drafting, submission, and management of the editorial process until publication.
Results
- Scientific evidence published prior to the planned decision windows.
- Meeting the strategic deadlines linked to European market access.
- Clinical positioning supported by a systematic review with meta-analysis developed using a rigorous and transparent methodology.
- Greater control and coordination of the scientific project from a single team.
- Minimal operational burden for the Medical Affairs team throughout the entire process.
