CLINICAL TRIAL OPERATIONS & SITE MANAGEMENT SERVICES
Cispact promises expertise in complex clinical trials by optimizing trial designs, properly planning and conducting operations, ensuring patient safety and maintaining data quality throughout. Our team of diligent and highly skilled professionals drive project management, patient recruitment & retention and site management/engagement to further facilitate your clinical trials. We also constantly achieve efficiency, streamline activities, imbibe flexibility and take responsibility to leverage solutions that best fit your goals of clinical development.
Clinical Trial Operations
- Clinical Study Contracts & Budgets, Management of SOW and Project Timelines.
- Engage Directly with IRBs and Competent Authorities on Behalf of Sponsor.
- End to End Clinical Trial Site & Patient Management.
- In-house and On-site Monitoring Management.
- Training for CRAs and Site Staff on the Study Related Procedures and Applicable Regulations
- Inspection & Audit Readiness, CAPA, Risk Assessment and Mitigation Plans.
Site Management Services
- Feasibility, Site Selection, and PI Selection Support.
- Participation & Presentation at Investigator Meetings.
- Patient Counseling, Recruitment and Follow-up.
- Onsite Trial Management (Initiation, Routine Monitoring & Closeout operations).
- Ensuring Protocol Compliance.
Protocol Deviations & Violations Management.
- Study Related Supply Inventory, Documents Archival and Maintenance.
- Reporting of All Types of Adverse Events to Sponsor and IRB.
- Inspection & Audit Readiness.