In-house site management activities:
- Primary and privileged contact for investigational sites providing an exceptional standard of service and care from site qualification through to termination
- Conducting site communications (ICF’s, local EC/IRB submissions)
- Supporting sites with any issues relating to protocol, drug, supplies or regulations.
- Prepare and collect site specific documents
- Assist sites to get access to study systems.
- Review of recruitment plan and enrollment updates
- Review site payment status
- Assess drug/study supply status
- Request outstanding documents
- Follow-up on data entry, query status and SAE.
Project management activities:
- Site regulatory package preparation and approval, collection of regulatory documents,
- Provide prepared Ethics Committee package to PI for submission and follow up to secure approval where required
- Ensure overall integrity of study implementation and adherence to study protocol.
Enhance sales revenues: identify problems and risks at trial sites remotely, and initiate corrective actions, thus reducing time to complete trials and achieving faster time to market. Decrease trial costs – Reduce your trial costs by conducting site visits only when high risk sites are identified, reducing travel cost and duration of stay at clinical trial sites.
Improve regulatory compliance: Respond to regulatory queries quickly, enabling faster verification of trial results, and consequently, faster drug approval and time to market.