Sites and Investigators Selection:
Key Factor of Clinical Trial Success
We identify, engage, and effectively work with experienced and competent sites. At ACTG-CRO, we understand that site selection has the potential to dramatically impact product approval timelines and corporate finances, this is why we incorporate in the evaluation plan to support the selection decision, these following assessment points:
- Staff qualifications: Experience in Clinical Research, avaibility, speciality, credentials and their performance as it relates to regulatory compliance. ACTG-CRO, as a GCP-Provider, offers ICH-GCP training to Investigators.
- Past Performance: clinical trial experience including in trials with similar enrollment timelines, enrollment target, and past enrollment rates.
- Facilities and Equipment: adequate facility space, drug and/or device storage space (we check and visit the Pharmacy within the hospital), security, types of source documents, and equipment needed for the study.
- Site Profile and Timelines: site types (e.g., hospitals or clinics, academic centers, non-profit, government, and private sites), site’s Institutional Review Board (IRB) meeting timeframe, and typical contract negotiation timeline.
- Population Profile and Access: eligible participants’ availability and proximity, disease/condition incidence, ongoing trials recruiting similar patients, and recruitment capabilities including resources for conducting outreach.
- Competition: concurrent trials in the same indication or targeting the same population profile that are ongoing or scheduled to start during study conduct.
Our large network of experienced investigators, having a high standing within the medical community, ensures the feasibility and quick implementation of the studies entrusted to us. Our partners have networks of doctors in city offices as well as privileged contacts with opinion leaders.