Monitoring
Monitors are the backbone of your clinical studies. Monitoring is a major cost factor in your project budget. Investing the money in an efficient monitoring service that considers the priority and complexity of your project without compromising quality is crucial for success.
BE/BE STUDIES (SMALL AND LARGE MOLECULES)
- Site Initiation Visit : - Evaluation of protocol, ICF and CRF, site readiness, Practical issue resolution before start of study
- In-Process Clinical Monitoring : - Subject Selection and Enrolment, Check-in, Dispensing of IPs, Dosing and Sample Collection, AE/SAE, Deviation and investigation
- Bioanalytical Monitoring :- MD/MV, Sample Processing, Protocol Compliance, Repeat analysis, ISR, investigation
- Statistical Phase Monitoring :- Calculation of pk parameters, outliers, deviations, reporting of data
- Report review
- Site close out
CLINICAL TRIAL (CT)
- Site Initiation visit, Site Monitoring visit, Site close out visit
- Training of staff for protocol and safety management
- IEC/IRB approval and CTRI registration
- Investigator meeting
- Vendor audits
- Risk based monitoring
- Protocol compliance, handling deviation
- Handling of AE/SAE and documentation
- Clinical trial supplies including IP management
- First patient first visit (FPFV) and Last patient last visit (LPLV)
- Notification to IEC/IRB
- Documentation and archival
- Site closeout