PROJECT MANAGEMENT

The successful progress of a drug candidate is a complex process of many interdependent components. Therefore, specific milestones are established in collaboration with regulatory affairs for each phase of development. These milestones integrate your management’s goals with our company’s resources.

For a Phase I trial, milestones include formulation, analytical and bioanalytical developments, initiation and completion of preclinical safety studies, and finally the development of a strategy to support the earliest date for this trial. Efficient timing is achieved by integrating the scheduling of a PreIND meeting and filing of an IND with the initiation of a First In Human (FIH) clinical trial.

DDC’s extensive experience with Contract Research Organizations (CROs) offers you recommendations for suitable CROs to conduct both nonclinical safety and Phase I studies.