Arete Clinical Research can provide project management & monitoring services that includes BA BE and clinical trial monitoring in India
Monitoring services include :
Pre-Study / Qualification Visit
Arete initiates a complete assessment of each clinical research site, capabilities of staff and evaluates the site's ability to adhere to FDA regulations, Good Clinical Practices (GCP's) and the overall conduct of clinical trials.
Clinical Monitoring Initiation Visit
Arete provides full initiation of the clinical research site which includes but is not limited to, review of protocol, regulatory documents, Case Report Form, enrollment requirements, investigational drug and responsibilities for the conduct of the clinical trial.
Interim Clinical Monitoring Visit
To ensure quality, Arête provide ongoing clinical monitoring throughout the conduct of the clinical trial. Activities Include:
- Informed consent review
- Eligibility verification
- Case Report Form and source documentation review
- Data retrieval
- Ongoing maintenance and review of regulatory documents
- Assessment of protocol adherence and drug accountability
Close-Out Visit
Upon completion of the clinical trial, Arete provides, final retrieval of all data, resolution of data clarification queries, assessment of regulatory documents, review of site regulatory obligations, investigational drug accountability and return.
Adequate Clinical Trial monitoring is necessary for safety of subjects, quality data and proper execution of study.
For each phase of clinical monitoring,Arete will provide to the client in a timely manner, a complete, detailed report after each completed clinical monitoring service.
If you are conducting BA BE studies or clinical trials in India, and are interested in independent monitoring services, please contact us for additional information.
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