Medical Writing
Our medical writing team at Clinexa understands that well written clinical trial documents are an extremely important link in the success of a clinical trial or a clinical development program. At Clinexa, we provide our clients with documentation that will helps them to realize their regulatory and marketing goals. We are highly proficienct in communicating complex clinical data in a concise and unambiguous manner.
Clinexa offers writing services for whole clinical trial development program and provides a full range of documents across regulatory, scientific, medical and commerical areas. We use client’s templates or our own ICH based ones as per requirement, thus allowing for flexibility that saves time and cost.
Some of our medical writing deliverables are:
Pre-submission documentation
- Investigator brochures
- Patient informed consent forms
- Investigational New Drug Application (IND)
Post-submission documentation
- Integrated summary of safety and efficacy
- Common technical documents (CTD), other formats
- Premarketing and post-approval annual reports
- Phase I-IV integrated clinical statistical reports (ICSR)
Scientific/medical communication
- Posters, abstracts, and manuscripts
- Presentations
- Educational material
- Marketing and training material