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OCT Clinical Trials, a leading European CRO headquartered in Russia, today announced it has completed enrollment for a phase III study on behalf of Indian pharmaceutical company Dr. Reddy’s Laboratories.
OCT successfully enrolled 440 patients — men and women over the age of 18 with acute influenza symptoms — to test the safety and efficacy of the drug Ibuklin. The enrollment target was reached within an impressive seven months, despite seasonal challenges of the indication. With 442 volunteers screened in total, OCT also achieved a low screen failure rate, at just 1%.
“We are pleased with OCT Clinical’s ability to meet our recruitment needs within our timeline, especially through the summer months,” said Alexander Khaymenov, MD, Ph.D., Head of Clinical Research at Dr. Reddy’s Laboratories’ representative office in Russia.
The open, comparative, randomized, multi-center study will run in parallel groups with a treatment period of five days. In this project, OCT Clinical has been responsible for a wide range of activities, including medical writing, regulatory support, project management, pharmacovigilance, monitoring, data management and biostatistics, logistics and writing the final research report.
“OCT is proud to support Dr. Reddy’s with our recruitment expertise,” said Maxime Stevens, Chief Strategy and Development Officer, OCT Clinical. “This outcome exemplifies our ability to serve sponsors and advance their studies under a variety of circumstances.”
About Dr. Reddy’s Laboratories Ltd.
Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses — Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products — Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, visit www.DrReddys.com