ABOUT OCT CLINICAL
OCT is one of the leading contract research organizations in Europe. Since 2005, the OCT team has conducted over 300 clinical trials in 29 therapeutic areas. The team of 200+ professionals provides a full range of high-quality CRO services for Phase I-IV and BE studies, with therapeutic expertise in oncology, cardiovascular, infectious diseases, rheumatology, GI, and other areas.
With strong local expertise and focus on quality, OCT Clinical ensures seamless clinical trial conduct and drug registration, on time and within budget.
Only target clinical trial participants
Since its foundation, OCT has successfully enrolled over 50,000 patients while preserving budgets and timelines.
With 20+ years of accumulated experience, our team has established efficient cooperation with 1600 research sites. Thorough feasibility analysis, coupled with well-coordinated communication with sites, allows us to recruit with minimal screen failure rates.
Full-service clinical study engagements
- Clinical Study Design Preparation
- Medical Writing
- Consulting and Regulatory Support
- Project Management and Monitoring
- Drug Safety and Pharmacovigilance
- Data Management
- Clinical Supply Services and Logistics
- Marketing Authorization
- GMP Inspection Support
Rescue studies as a special expertise
Another specialty area for the OCT team is rescue studies. When clinical trials hit roadblocks, the team is ready to step in. When a takeover of an active trial is needed, the OCT Clinical experts create a study rescue plan focused on resolving current bottlenecks and study challenges and an expedited study schedule to get it back on track.
Race and ethnic inclusion matter. When creating a clear picture of the safety and efficacy of a drug, uncover diversity's critical role in studies for providing clinically meaningful insights.
Uncover how a leading Eastern European CRO completed patient recruitment ahead of schedule in an erectile dysfunction study involving the evaluation of an innovative MED3000 topical gel.
Amid challenges during the COVID-19 pandemic, discover how recruitment was completed in three countries for a Sweden-based pharmaceutical company's phase 2b study.
Gain insight into why research sites in Central and Eastern European countries are becoming popular destinations for clinical trials with the latest industry Pages™ Report.
Gain insights from Kristina Bondareva, Head of Biostatistics at OCT Clinical, on the significance of the Addendum and the importance of adopting the estimand framework in clinical trials.
Unearth some of the challenges and prospects faced by clinical trial teams working on vaccine development against COVID-19.
Considering an ICH E9R(1) Addendum on Estimands and Sensitivity Analysis, several sensitivity analyses are now regarded as supplementary analyses. Learn about these changes and their effects oncology trials.
Check out the results from a clinical first-in-human study evaluating the safety and tolerability of an investigational cancer immunotherapy in patients with advanced melanoma.
Learn how database validation, database lock, and the development of the electronic CRF were used in a HER2-positive operable breast cancer study.
Gain insight into how a dermatology-specialized European CRO joined forces to carry out interim statistical analysis in its study on seven subjects and prepared necessary data packages for regulatory submission.