This registration study was awarded to OCT by one of our global sponsors. Sine OCT has several full-time medical writers study design and clinical documentation processing was delegated to us. Quality medical writing is crucial for every project. Being the first step in a long and expensive process of clinical research, study and documents design may be your direct way to success or a complete failure. OCT realize that and ensure on-time delivery of high-quality documentation. All OCT medical writers are PhDs in medicine with wide experience in different therapeutic areas. In total, OCT medical writing team have developed more than 30 study designs and clinical documents sets which have been approved by Russian Regulatory Authority with no comments. An average study design development and clinical documents package preparation takes our medical writers one month. This particular study was not an exclusion. OCT Medical writers have developed and finalized clinical study protocol, informed consent form and patient diary, investigator’s brochure, CRF, study manuals and plans. All documents gave been prepared in accordance with Russian country-specific requirements and ICH-GCP. At the end of the study OCT medical writing team will be responsible for final study report preparation.
To learn more about our medical writers and services they provide, please contact us. We would be glad to assist you in:
The next step for this study will be regulatory application preparation. OCT will enroll 60 patients at 13 sites in Russia within 2,5 month period. As most of OCT trials this is quite a ырщке timeline. Thorough feasibility study and sites selection process gives us confidence in successful on-time completion of this study.