Experience, Teamwork, and Proven Success
The medical writing team at PROMETRIKA has a strong and varied background in clinical research that contributes to our ability to deliver regulated content and other clinical research documents. In addition, we believe that close collaboration with the sponsor and project teams is key to clear, meaningful interpretation and presentation of clinical data. Our work, continuing education, and knowledge sharing between team members keeps us up to date on relevant regulatory guidances. Our writers are able to help sponsors approach documents in a way that reflects regulatory authorities’ best practices.
PROMETRIKA’s medical writers produce submission-ready protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), and NDAs/MAAs, collaborating directly with the sponsor throughout development. This ensures quality, consistency, and adherence to the sponsor’s goals in all deliverables. Our experience extends to the preparation of patient narratives, posters, manuscripts, journal articles, and slide presentations, and we can customize our level of service according to sponsor needs. We work closely with our experienced regulatory strategists (more information here), along with our sponsors, to ensure that all documents align with the optimal submission pathway.
OUR SERVICES
- Clinical study protocols
- Clinical Study Reports (CSR) – phase 1 to phase 4
- INDs, NDAs, and MAAs (ISS/ISE and other summary sections)
- Journal articles, abstracts, posters, presentation support
- Standard Operating Procedures (SOP) and Work Instructions (WI)
- Development Safety Update Reports (DSUR) and Periodic Safety Update Reports (PSUR)
- Briefing documents supporting INDs and other submissions
- Investigator Brochures (IB)
- Patient narratives
PROMETRIKA’s Medical Writing & Regulatory Team — A Snapshot
- Average of 20 years of writing and regulatory experience
- Word 2019 Certified team members