Services
We mainly offer Following 3 Services
- Clinical Trial Site Management Organization
- Ethical Committee related Services
1 ) Clinical Trial Site Management Organization
- - Study start-up including potential sites and experienced PI suggestions.
- - Study documents submission to Ethics committee.
- - Feasibility of studies and initial documents preparation at site level.
- - Subject recruitment &follow-up.
Clinical Data Management
We offer fast turnaround and a flexible, efficient process for any project, including:
- Data entry in paper CRF or eCRF
- Data submission on fast-trac kprocess to CRO/Sponsor
- SMO services
- Document archival facility as per regulatory guidelines.
- Data submission on fast-trac kprocess to CRO/Sponsor
- SMO services
- Document archival facility as per regulatory guidelines.
2) Ethical Committee related Services
- IEC formation and DCGI Registration
- SUGAM Portal formation
- IEC Re-registration
- NAITIC Portal formation and Registration
- NABH Accreditation for IEC
- ICH-GCP training programs for IEC Members.
- SUGAM Portal formation
- IEC Re-registration
- NAITIC Portal formation and Registration
- NABH Accreditation for IEC
- ICH-GCP training programs for IEC Members.
Note: Having experience of All the regulatory including USFDA, DCGI and EMA study and Inspections.
