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.
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
- Initial new employee training on ICH GCP, SOPs etc.
Clinical Trial Supply Management
- Our services include Regulatory Consulting including regulatory pathway to US FDA, EMEA and MHRA. Support for 510(k), De Novo submissions etc,
- We can plan and conduct interactions with regulatory agencies (FDA, EMA and MHRA), including the preparation of the necessary documentation (briefing book package) for endorsement of the clinical trials (BPD type II meetings with FDA and Tailored Scientific Advice meeting with EMA and MHRA).
- Evaluation and recommendations of the CMC package that will be presented to the regulatory agencies.
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.