Trial Management
Conducting research in India requires a partner who offers significant experience with FDA-regulated clinical trials and provides local
support to both the sponsor companies and research sites. Investigator Support Services (ISS) offers the capabilities and expertise to take on
any project, large or small.
Management and Regulatory Experience
With 45 years of regulatory and 125 years of clinical research experience, our site management team has the expertise necessary to navigate the complex operating and regulatory environment of India. Our sites have an excellent track record, with 350 trials conducted and 100% FDA
acceptance of study data. To ensure trial success, our sites provide:
- Placement of full-time coordinators trained in ICH-GCP, schedule Y and local regulatory requirements
- Modern technology infrastructures and experience with EDC and IVRS
- Rapid turn-around for regulatory submission, including Ministry of Health (MOH) and IND approval
Comprehensive Trial Services
Your clinical programs benefit from a flexible service model designed to serve sponsors independently or compliment services offered by global CROs. A site centric approach helps ensure on-time enrollment, strong retention, and quality data with 100% FDA approval through a comprehensive clinical trial and site management portfolio:
Pre-Trial
- Site identification, evaluation and selection
- Principal Investigator (PI) selection and training
- Study feasibility assessment
- Coordinating translation of essential documents
- Identifying couriers and support service vendors
- Regulatory submission and rapid approval
- Obtaining import/export licenses for Clinical Trial Materials (CTM) and samples
- IRB submission and rapid approval
- Site set up in accordance with trial protocol
- Document collection and management
- Creation of source document template
- Preparation of site for Site Initiation Visit (SIV)
- Patient pre-screening for chronic disease trials
During Trial
- Informed Consent, screening and enrollment assistance
- Patient retention and compliance support
- Managing CTM distribution and logistics
- Coordinating central lab logistics & sample flow
- Coordinating monitoring & audit visits
- Coordinating subject reimbursements
- Maintaining and updating trial master file
- Coordinating Serious Adverse Events (SAE)
- Data management and performance tracking
Post-Trial
- Coordinating close out visits
- Query resolution and document archiving
- Final reconciliation and return of CTM
- Final report to ethics committee (EC)
- Settlement of all payouts
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