BCI’s
medical writing consultants will either develop or assist the client
in developing clear, concise documents that are scientifically /
medically accurate and fully compliant with regulatory requirements.
BCI can assist with global IND or clinical trial applications and
other regulatory submissions such as:
- Global clinical trial applications
- Drug, device and biologics marketing applications
- Preclinical and scientific reports
- Investigator brochures
- Premarketing and post-approval annual reports
- Phase I-IV protocols and integrated clinical statistical reports
(ICSR)
BCI’s medical writing consultants are experienced in the
preparation of :
- Clinical development plans
- Protocols
- Clinical study reports
- Clinical sections of Common Technical Documents (CTDs)
- Clinical sections of New Drug Applications (NDAs)
- Investigator brochures and annual updates
- Pharmacovigilance documents
- Pre-FDA meeting briefing documents
- Preclinical study reports, expert reports, and summaries
- Written and tabular summaries
- Benefit/risk assessment reports
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