Support that respects PI responsibility
Investigator support that actually supports.
Principal investigator responsibility cannot be outsourced. It can, however, be supported by a well-built site operation.
MDTrials supports the systems, coordinator work and documentation around investigator oversight. Medical decisions, participant safety decisions and the principal investigator's regulatory responsibilities remain with the investigator and cannot be transferred to the site-management organization.
Training. Delegation. Coordination.
Support for investigators
- GCP and protocol-specific training coordination
- Clear delegation structures and maintained delegation records
- Coordinator recruitment, training and supervision within the site model
- Monitoring, audit and inspection preparation
- Support with investigator safety-reporting workflows and study communications
- Sponsor and CRO coordination and issue follow-up
- Study-capacity planning around the investigator's clinical workload
New to clinical research?
Research experience is helpful but not the only predictor of a successful site. For suitable clinics, MDTrials can build capability progressively — starting with training, governance and studies that fit the practice, then expanding as the investigator and site team develop experience.
Protecting the clinical practice
Research must coexist with patient care. We plan coordinator coverage, visit flow and study volume around real clinic capacity, and we will recommend against accepting a study when the operational burden is not a responsible fit.
Frequent Questions
- What are a principal investigator's responsibilities under GCP?The PI is responsible for the conduct of the trial at the site, including protocol compliance, participant safety and informed consent, medical decisions, accurate records, supervision of delegated activities, and communication with the sponsor and the research ethics board. These responsibilities remain with the investigator regardless of the operational support provided.
- How much of my time will a study take?That depends on the protocol and the visit schedule. We plan study volume around real clinic capacity and will tell you when a study does not fit.
- What happens if my site is inspected?We prepare with you — reviewing documentation, rehearsing the process and attending where useful. Sites that maintain routine readiness rather than preparing reactively find inspection straightforward.
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Training, delegation and inspection-readiness support that respects the line between assistance and the investigator's own accountability.