OTD ONCOLOGY THERAPEUTIC DEVELOPMENT

OTD ONCOLOGY THERAPEUTIC DEVELOPMENT is a contract research organization specialized in Oncology based out of 100 RUE MARTRE, CLICHY, France. As a ‘boutique’ CRO, OTD offers a personalised medical oncology approach with a strong emphasis on early clinical development. Our working model and strategy are best adapted to collaborating with small/medium biotech companies, eliminating procedural layers which are frequently an integral part of larger structures. OTD’s approach, promotes rapid and adaptive clinical development, using real-time individual patient data with direct client communication and a personalised investigator network. As an oncology-focused CRO, our procedures are medically-driven, with strong implication of a medical oncologist at all levels of clinical operations. This includes continuous monitoring of patient inclusion by our in-house medical oncologist, regular direct interaction with the site PI to maintain motivation, early identification of potential issues for patient inclusion and dose escalation. In addition, the medical oncologist is responsible for medical validation of data, verifies the application of clinically-relevant project-specific procedures and instructions (inclusion/exclusion criteria; dosing and modifications; tolerance; efficacy criteria), and contributes a global and detailed view of the patient data to the Safety Monitoring Committee and dose escalation decisions. This ensures the coherence of the entire study data on a scientific and medical basis. The medical oncologist also plays an integral role in the review of the protocol, amendments, CRF, monitoring reports, data validation, SAE cases, and the CSR, to ensure clinical accuracy and relevance.