We provide medical writing service for all phases of development for indications ranging from rare genetic diseases to large global trials. We employ efficient processes for any project large or small.
As GCP experts, we have an in-depth understanding of document guidelines in multiple therapeutic areas.
We are flexible in our approach and can work independently or collaborate with our clients based on their unique requirements.
We write and/or QC all of the following documents:
- Regulatory submission-ready documents (including IND, CTA, NDA/sNDA, BLA, MAA, JNDA)
- CTD Module 2 Documents
– Section2.5 (Clinical Overview)
– Section 2.7.1 (Summary of Biopharmaceutic Studies)
– Section 2.7.3 (Summary of Clinical Efficacy)
– Section 2.7.4 (Summary of Clinical Safety)
- CTD Module 5 Documents
– Integrated Summary of Efficacy (ISE)
– Integrated Summary of Safety (ISS)
- Clinical Study Reports (CSRs) (Phase 1, 2, 3, and 4)
- Clinical Protocols
- Investigator Brochures and Updates
- Patient Narratives
- Regulatory briefing documents (eg, End-of-Phase 1, 2, or 3, Pre-NDA, and Advisory Committee)
- Development Safety Update Reports
- Risk Benefit Assessment