We are committed to the quality of our services. It is our goal provide to investigative sites professional advice. We offer a
consulting service to assist sites to obtain sponsored studies. We assist sites from site selection to close out to deliver an exceptional service in Clinical Research ensuring patient safety and
quality of data.
We offer the following services:
- Web page design.
- Standard Operating Procedures (SOP)
- Assisting sites to obtain sponsored studies.
- Assisting sites in contract review and budget negotiation.
- Assisting sites in regulatory documents completion and maintenance.
- Assisting sites in documents submission to Institutional Review Board (IRB) for approval and renew of approval.
- Assisting in Start Up activities.
- Assisting sites in site initiation and trial close-out operations.
- Assisting sites in patient Recruitment strategies and tools.
- Assisting sites in source documents creation and audits.
- Assisting sites in Good Documentation Practices.
- Data entry audits, query resolution assistance.
- Assisting sites in subjects Follow-up
- Assisting sites in reporting Adverse Events (AE) and Serious Adverse Events (SAE) to the Sponsor and the IRB.
- Ensuring protocol compliance. Protocol Deviations management and Corrective Action Plans (CAP)
- Ensuring ICH/GCP compliance.
- Assisting sites in trial-related documents archival and maintenance