CLEAR PRESENTATIONS … Proven Success
The medical writing team at PROMETRIKA believes that close collaboration with the sponsor and the project team is the key to clear, meaningful presentation and interpretation of clinical data. By staying abreast of all relevant FDA and ICH regulations and guidances, our writers are able to deliver documents that reflect regulatory authorities’ current thinking.
PROMETRIKA’s medical writers are engaged throughout the development of protocols and Clinical Study Reports (CSRs), ensuring the creation of high-quality documents that meet the sponsor’s goals for the clinical development plan. We provide submission-ready regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA). Our experience extends to the preparation of Standard Operating Procedures (SOPs), patient narratives, posters, manuscripts, journal articles, and slide presentations.
Regulatory services at PROMETRIKA are provided by seasoned professionals. All are experts in the interpretation of the regulations and guidances, and in the development of customized regulatory strategy for clinical development programs. Our regulatory experts collaborate with sponsors to ensure that interactions with regulatory bodies are productive and effective, leading to the best possible outcome for the program.
- Clinical development plan
- Clinical study protocols
- Clinical Study Reports (CSR) – phase 1 to phase 4
- INDs, NDAs (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
- Regulatory consulting and strategy
- Regulatory agency meetings
PROMETRIKA’s Medical Writing & Regulatory Team — A Snapshot
- Average of 20 years of writing and regulatory experience