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MEDICAL WRITING
A well-written regulatory document is a direct reflection of the quality assurance and care of your organization. BCF offers Medical Writing
services for Phase I through Phase IV clinical trials.BCF's experienced writers produce documents that are scientifically and medically precise as well as compliant with ICH and regulatory requirements. We will enhance the quality of your document submissions to the regulatory authorities.
BCF provides medical and technical writing as an integral part of a full drug development program, a Phase I through IV clinical trial, or as a stand-alone service. Each project begins with an exacting clinical protocol and ends with an integrated clinical and statistical report and/or manuscript for publication. BCF's experienced team of writers ensures that your regulatory submission documents are clear, concise, scientifically and medically accurate, and fully compliant with all applicable ICH and regulatory requirements.
Following are the documents we produce:
- Integrated Summaries of Safety and Efficacy
- Integrated Clinical/Statistical Study Reports
- Investigator Brochures
- New Drug Applications
- Package Inserts
- Product Licensing Applications
- Technical Responses to Agency Questions
- Advising Committee Meeting Preparation
- Annual IND Reports
- Final Study Reports
- Review and Editing of Documents
- Manuscripts