Investigators

For physicians considering clinical research, the clinical work is rarely the obstacle. The obstacle is everything around it. This page sets out what taking on a study involves, and which parts we carry.

What stays with the investigator

Certain responsibilities belong to the principal investigator and cannot be delegated away. They are yours in any arrangement:

  • Medical decisions regarding participants on the study
  • Assessment of adverse events and their relationship to treatment
  • Eligibility determination and final sign-off on enrollment
  • Overall supervision of study conduct at the site

What we carry

  • Regulatory submission packages and the investigator site file
  • Coordinator staffing, scheduling, and protocol training
  • Pre-screening and recruitment against eligibility criteria
  • Source documentation and data entry to sponsor timelines
  • Monitoring visit logistics and query turnaround
  • Sponsor and CRO correspondence

If you have a practice and a patient population

The usual path is a feasibility conversation first: which protocols suit your population, what the visit schedule would demand of your clinic, and what space and equipment a study requires. Nothing commits until that is clear.

If you are new to research

First-time investigators typically need Good Clinical Practice training, a current CV on file, and familiarity with the protocol and consent process. We can help arrange GCP training, whether through our team or an external provider. We set up the documentation and walk through what a monitoring visit looks like before the first participant is screened.

Questions worth asking before you agree to a study

  • How many eligible participants does my practice realistically see per month?
  • What does the visit schedule demand — duration, frequency, procedures?
  • What equipment or storage does the protocol require that I do not have?
  • Who is doing the documentation, and when?
  • What happens if enrollment runs behind?

We would rather answer these honestly up front than enroll a site that cannot deliver.

Interested in becoming an investigator?

Get in touch to start a feasibility conversation about your practice and population.

Contact Us