Medical Writing
Our medical writers work closely with our project managers and the lead CRA to prepare documents that meet regulatory requirements on an ongoing basis throughout the entire study process. Our writers’ knowledge of ICH guidelines and clinical study statistics informs the content and format of clinical study reports (CSRs).
Medical Writing Services
- Produce ICH-compliant CSR shell before the trial is completed so the client can review, edit and approve the format in advance
- Provide the client the first draft CSR within 4 weeks of database lock
- Clinical and preclinical study protocols
- Informed consent forms
- Investigator brochures
- ISS/ISE (integrated summaries of safety and efficacy)
- Manuscripts, abstracts, poster presentations and summaries
- DSMB reports
- FDA applications and submissions: IND, IDE, 510(k), NDA, BLA, PMA, ANDA, orphan drug designation (ODD), request for designation, breakthrough therapy and fast track
- New dietary ingredient (NDI) applications
- Regulatory strategy
- CMC expertise
- International regulatory agency submissions (CTA, IMPD, MA and CE) and meetings
- Adjudication committee management
- GLP, GCP, GMP and GAP audits and certifications
- Clinical research results evaluation
- Clinical development plan
- Product development assessments
- Clinical research seminars and trainings
- Regulatory affairs IND-enabling guidance (preclinical and manufacturing)
- eCTD and eCopy formatting and submissions
- Global consulting (separate from certification)
