OTHER
SERVICES
OTHER
SERVICES
OTHER SERVICES
Central Ethics Committee Review
- For Non Regulatory studies, we offer Central ethics committee review services across Multiple sites.
- Our Central Ethics committee is multidisciplinary and multi-sectoral in composition, and functions as per the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.
- We have undertaken central review of several studies including one of the largest observational studies in India covering over 450 hospitals/ sites.
Quality Assurance
Our independent quality control department conducts its own audits on an ongoing basis with a strong focus towards continuous improvement. At the same time, the focus of QA is on process efficiency and generating relevant management information to evaluate new improvement opportunities. We offer the following QA services
- Investigator site audits
- Sponsor / CRO audits
- Vendor audits / assessments
- Pre – Regulatory inspection audits
- Medical and regulatory affairs audits
- System audits
- Standard Operating Procedure writing
- CAPA Support
- Training in ICH GCP & SOPs
Facilitating Site & Investigator Contracts & Payments
Clinical Trial Supply Management
- Contract Negotiation & Preparation
- Legal and Regulatory Compliance
- Contract Review and Approval & Execution
- Contract and Payment Compliance Monitoring
- Contract Renewals or Amendments
- Site & PI Payment Tracking and Documentation
- Managing the payment process, maintaining transparency, and addressing any issues promptly
Our services include inventory management of clinical supplies. We have an ICH compliant storage and -80 Degrees refrigerators for serum samples / tissue blocks when required for long term preservation. We are involved in all aspects of overall drug accountability and destruction: from the site initiation to study close out of a clinical trial.