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Trial Management Services:
Pre Study Site Preparation:
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Site feasibility studies as per protocol requirement. Site selection and assessment. Assortment of essential documents. On-site briefing of Investigators and research team. Ethics Committee Dossier Preparation, Submission and Follow-up.
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Staffing with skilled and experienced Clinical Research Coordinators. Investigational Medicinal Product (IMP) management Logistics management Site specific Standard Operating Procedures Training (SOP's)
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Patient follow up Tracking CRFs Maintenance of Site documents Resolution of queries Research site liaison Progress and status reports Serious Adverse Event reporting within stipulated timeline. Punctual elucidations of Data Clarification Forms.
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