Our Medical Writing group provides accurate documentation that complies with ICH guidelines and meets the FDA/EMEA regulatory requirements, which is key to international business success.
With offices in the US and Europe, our staff can support all your submission needs. Our commitment to creating quality documentation according to the timelines you require means that Clinquest is uniquely qualified to prepare a wide range of medical and scientific documentation to support global product development.
Clinquest employs a highly qualified writing staff with master’s degrees, and over 20 years of clinical research and medical writing expertise. Our writing staff works closely with your team in unison with our Clinical, Medical, Regulatory, and Quality Control groups to organize, write, edit, and produce precise documentation for a wide variety of therapeutic areas and devices.
To achieve your goals, Clinquest provides the following comprehensive and flexible medical writing services for small and large projects involving all aspects of the clinical and regulatory process, from Pre-IND through the NDA/MAA.
Medical Writing Core Services:
- Product Development Plans
- Investigator Brochures
- Informed Consent Forms
- Study and Core Laboratory Procedure Manuals
- Independent Review Charters
- Clinical Study Reports
- Pre-Clinical and Regulatory Meeting Packages
- Clinical Sections of the Common Technical Document (CTDs)
- Quarterly and Annual Updates
- Periodic Safety Updates and Pharmacovigilance Documentation
- Clinical Hold Documentation
- Data Safety Monitoring Board (DSMB) Charters
- Medical and Scientific Literature Review Reports