Samsung Bioepis, one of the world's leading biopharmaceutical companies, ran a clinical trial for its own biosimilar product in 13 countries. OCT Clinical was contracted as a local CRO and was responsible for running full-scale clinical trial activities with the recruitment goal of 254 patients across 21 research sites.
This was a Phase III, randomized, comparative, double-blind, two-parallel group, multicenter study in subjects with metastatic or recurrent non-squamous non-small cell lung cancer. The aim of the study was to demonstrate the efficacy, safety, pharmacokinetics, and immunogenicity of the of the investigational drug (biosimilar) compared to a comparator during a 24-week chemotherapy period.
OCT Clinical is now operating under Palleos Healthcare brand name.
“The merger will undoubtedly create significant synergies, not just doubling but squaring the expertise of both companies”, Philip Räth, Ph.D., managing director at Palleos, said in the release.
“OCT Clinical is proud to join forces with palleos healthcare, as it has an excellent reputation in the industry it serves. Now we can offer tailored solutions to our clients to meet their diverse clinical research needs and accelerate the time of bringing their products to market”, Dmitry Sharov, CEO at OCT Clinical.