Phase II - Phase IV

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. The team has 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.

The 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 (SAS®), 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 Life Sciences:

• 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