With more emphasis on increasing the number of trial subjects conjugated with the extensive scrutiny of safety of the products and organizational pressure to decrease the R&D costs, India serves as an optimum destination for the industry. We have strong capabilities in seamlessly managing projects that vary in size, complexity, therapeutic area and specific customer requirements whether with a single service scope of work or a full-service global program.

Our capabilities in Phase II - IV trials are: 

  • Project Management
    • Project feasibility
    • Financial and resource management
    • Quality control and oversight
    • Regulatory consulting and filing
    • Risk and contingency planning
    • TMF setup & maintenance
  • Medical Writing
    • Study documents design and review (Protocol, IB, ICF and patient diaries)
    • Statistical consulting
    • Clinical study report writing
  • Site Management
    • Site Initiation
    • Ethics committee coordination
    • Site budgets and contracts
    • Complete site support
    • On-site/remote monitoring
    • Risk based monitoring
  • Patient Safety
    • Pharmacovigilance
    • Medical monitoring support
    • DSMB support
  • Data Management and Biostatistics
    • EDC or paper data capture
    • Adverse event and medication coding using standard clinical coding dictionaries
    • Data integration and legacy data conversion
    • Statistical Programming (SASŪ), analysis and reporting
  • Quality Assurance
    • GCP, GLP and GMP audits
    • Clinical study report audits
    • Database audits
    • System audits
  • Trial support services
    • Randomization services
    • Central laboratory
    • On-site drug storage and cold room facility with pan-India drug distribution network
    • Regulatory applications and authorizations

Advantages of Reliance:

  • Well networked with large investigator pools across diverse therapeutic areas
  • Country-wide spread of study sites, managed effectively through regional presence
  • Capability of handling large and complex studies
  • Support Marketing activities for launch and conduct of Phase IV studies
  • Access to emerging markets
  • Experienced in developing bioanalytical methods for biosimilars, including mAbs