RegSource Clinical can support and help achieve corporate goals for drug development by providing quality consultants (
Program Managers, Project Managers, Clinical Monitors/CRA's, etc.). We provide strategic solutions from IND submission through peri-approval phase with the goal of process development/implementation and risk mitigation. Areas of expertise include: Establishing Trial Master Files, Establishing Standard Operating Procedures (SOPs), Good Clinical Practice Training (GCP), Implementation of Strategic Processes, Assessing Vendors, Establishing Timelines and minimizing corporate risk.
The RegSource Clinical Team focuses on the drug developmental goals and provides a customized plan that reflects yours needs. As new drugs move into clinical development, our Program Management teams will assist in developing strategies that best address clinical, safety and regulatory issues to move the research through the development process. Our Team averages over fifteen years of experience in drug development, drug monitoring and provides significant value in creating drug development strategy processes.
Our Program/Project Managers and Clinical Monitors incorporate an assortment of services to support First in humans, Phase IIa (proof of concept services), Phase IIb, Phase IIIa and peri-approval.
