Our Clinical phase monitoring services ensure the conduct of study in compliance with regulatory, protocols, SOPs, contracts, agreements and other written procedures. We also assess the adherence of Good clinical practices at clinical study site. Our Clinical phase monitors have real time experience in BA/BE clinical phase CROs.
We cover all critical check points with a pre defined check list during in-processing and retrospective audits. Our review starts from registration to selection of subjects, subject enrolment, randomization, subject dosing, sample collection, transfer for storage, raw data and safety well being of the subjects.
We ensure the data integrity and ethical standards followed at all the stages of bioavailability and bioequivalence study conduct to assure the sponsor with scheduled audit agenda shared with clinical study centre.
Clinical phase review includes :
- Regulatory and IEC approvals
- Trial master file and investigational products
- Protocols and agreement compliance
- Registration and selection criteria
- Subject enrolment and dosing
- Sample collection and transfer
- Storage conditions and tracking details
- Case reports and consent forms
- Safety and wellbeing of subjects
- GDP and GCP compliance