Oncology Phase l Study in Solid Tumors This was a Phase I bioequivalence study of a chemotherapeutic agent for a global specialty pharmaceutical and medication delivery company. The company was under an extreme pressure to enroll 20 subjects in 30 days. OCT had a 3 month preparation and approval period and enrolled 20 patients in one month.
Through proactive project management, advance planning and the efforts of the dedicated team OCT successfully obtained all necessary regulatory approvals and import/export licenses, and conducted the trial within the promised timelines. European central laboratory was involved for PK testing and confirmation of the study drug initial. Close collaboration between the clinical and safety team members ensured timely closure of all SAEs and outcome events. We’ve conducted clinical projects in field of oncology since 2005, allowing us to develop an extensive network of experienced sites as well as strong clinical research teams. This challenging but successful Phase I study was the beginning of a long drug research. This chemotherapeutic agent has been finally approved by FDA and EMEA and indicated for use in treating patients with metastatic breast cancer, prostate cancer, non-small cell lung cancer and gastric adenocarcinoma. We are proud to have taken part in such a great clinical research.