C&R Research has a wide breadth of knowledge and experience drawn from pharmaceutical companies, laboratories, regulatory authorities, and clinical research organizations. Our medical writing experts work closely with other colleagues in clinical development planning and study design consulting. By adhering to ICH-GCP and KGCP guidelines as well as regulations of Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration, and European Medicines Agency, C&R Research’s medical writing services team delivers a broad range of high-quality documents.
Clinical Development Feasibility and Study Design Consulting
Investigator Brochure and CTD (Common Technical Document) Writing
Protocol and Trial-Related Documents Development
CSR (Clinical Study Report) Writing and Conference Presentation Support
Clinical development planning
C&R Research’s medical writers possess master’s and doctorate degrees in medical, pharmacy dental and nursing sciences, biology, genetics, and microbiology/virology. Through closer collaboration with internal and external experts in Q-fitter and C&R Research’s medical writing experts are proactively engaged in overall medical consulting process, ranging from product development feasibility/market survey and advisors’ meeting for protocol development.
Protocol design and development
C&R Research suggests guidance to the best clinical development strategy by analyzing the documents related to an investigational product, including Investigator’s Brochure, under mutual cooperation with related departments and sponsor according to project needs.
In drafting the synopsis of a protocol, C&R Research’s medical writers work closely with key opinion leaders of clinical research centers and go over each element of the protocol in more detail, from regulatory requirements by MFDS and Institutional Review Board to smooth conduct of clinical trial and reliability assurance
Analysis of results and reporting
C&R Research’s medical writers draft a clinical study report (CSR) after checking all procedures that involve database lock and statistical analysis. CSR is created in compliance with related regulations and global standard forms, and through closer collaboration between company-wide departments and investigators and sponsor, internal/external review and quality control will follow. When necessary, literatures used for scientific reporting may be further screened.
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