Experience. Integrity. IMPACT.
Experience. Integrity. IMPACT.

medical

Early Phase Clinical Trial Management

Getting your drug or biologic into the clinic is undoubtedly one of the most important milestones of any development program.

Importance of Early Phase Activities

The data obtained from early phase clinical trials, from Phase 1 first-time-in-human studies through Phase 2 proof-of-concept and dose-range finding studies, are vital to effectively design Phase 3 registration studies. Therefore, early phase clinical trials need to be meticulously designed, managed, and monitored from both medical/scientific and regulatory standpoints.

The increasing desire to streamline clinical development programs by employing adaptive trial designs in Phase 2 heightens the need for careful attention to early phase strategy and implementation.  The professionals at IMPACT have the skills required to ensure these studies are executed on-time and on-budget and provide the results needed to develop a clear pathway forward.

How IMPACT Can Help

The clinical research scientists at IMPACT can serve as invaluable members of your early phase clinical team.  We have a track record of successful implementation, management, and execution of early phase clinical trials, and we have standard operating procedures that ensure we provide our clients with the highest quality service possible.

Because of our strength in providing drug development and regulatory consulting services, coupled with our experience and expertise in the Pre-IND/IND stage of development, our clients often request that we help them design, manage, and monitor their initial clinical trials as well.  Even if we have not been involved with early stage consulting, the team at IMPACT is still a strong option if you choose to outsource Phase 1 and Phase 2 clinical trial management and monitoring activities.

Services Offered

Our team of dedicated and well-trained professionals can serve as key players for your team by:

  • Assisting in the design of your clinical trial
  • Authoring your clinical protocol, protocol amendments, informed consent form, and case report forms
  • Conducting site evaluation and initiation visits to ensure that appropriate sites are selected and thoroughly trained on all protocol-specified requirements
  • Performing periodic and close-out monitoring visits to ensure that the study staff is adequately conducting the trial, resulting in the generation of clean, high-quality data
  • Tracking study progress against agreed-upon timelines and instituting timely corrective actions if activities get off track
  • Overseeing the shipment and return of study drug
  • Coordinating and managing external vendors (e.g., central laboratories, IVRS providers, study drug management)
  • Working closely with data management to help in the generation of a clean database that is locked as quickly as possible following last patient/last visit
  • Interacting with biostatistics to ensure the production of on-time and high-quality final tables, listings, and figures
  • If necessary, preparing study sites for FDA inspections
  • Authoring the clinical study report

Need help getting your drug from the bench into the clinic? If so, please contact us. We’re happy to discuss your specific needs.

For specific examples of our early phase clinical trial management capabilities, please check out our case studies and testimonials.