Sponsor a study at Affinity Health’s research institute
Our research institute brings together over 30 physicians in multiple specialties who offer trial services to the highest standards of Good Clinical Practice. Backed by our experienced coordinators and executives from the industry, our physicians are dedicated to capturing high quality data for our sponsors while ensuring our patients’ comfort and safety.
Affinity Health is able to provide a unique research experience for our patients and an unparalleled level of quality for our sponsors. We accomplish this by centralizing the common functions of study start-up and execution but allow participating physicians to run their studies from their clinics where patients feel most comfortable.
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What to Expect
Site Feasibility and Start-up
Affinity Health understands that study sponsors demand quick turnaround during site feasibility and study start-up. To help meet that goal, we have a dedicated contract/budget negotiator and recruitment specialist. We maintain the flexibility to use sponsor language in CSAs. Turn-around for budgets and CSAs is 24 – 48 hours. We also have a dedicated regulatory specialist and return regulatory packets for initial review within 48 – 72 hours.
All PIs and CRCs are GCP proficient and trained on Affinity Health’s SOPs. All CRCs are also IATA certified, in addition to being familiar with core EDC platforms such as DataLabs, Inform and Rave.
Clinical Trial Management System
Affinity Health uses a Clinical Trial Management System to track subject visits, staff effort and protocol details. This allows us to communicate both with the sponsor and the PI in an organized and efficient manner.
Affinity Health’s research institute has dedicated recruitment specialists who focus on patient pre-screening, subject recruitment and retention. It is part of our procedures to pre-identify eligible patients in our database prior to the PSV in order to ensure successful patient recruitment out of the gate.