OCT provides a full range of medical writing services (design and preparation of):
- Investigator brochures (IBs)
- Study protocols
- Case report forms (CRFs)
- Summary of product characteristics
- Informed consent forms (ICFs)
- Standard Operating Procedures (SOPs)
- Efficacy and safety summaries
- Clinical expert reports
All documents are written clearly and concise by specialists with medical expertise and scientific experience. They meet federal/local requirements as well as ICH GCP and FDA standards. Documents can be written both for trials conducted by OCT and as stand-alone projects.