Clinical Trial Management

KlinEra has the experience and global resources to help plan and manage your most important clinical trials.

Since 2005, KlinEra has partnered with some of the largest pharmaceutical, biotech and device companies, providing innovative and customized clinical trial and research services.

To date, we've completed over 50 large-scale Phase 1, 2 and 3 trials successfully by implementing complete clinical trial management, medical monitoring, data management and site management services all utilizing high quality protocols and Good Clinical Practices (GCP) with a focus on clinical trials in India.

From start to finish, we'll ensure that all aspects of your trial are professionally handled with quality and integrity of data always at the forefront while establishing the shortest route to market for your product.

KlinEra provides expert services in all key areas of the drug development process including:

  • Selection of sites and feasibility assesment
  • Regulatory submissions
  • Translation services for clinical trial documents
  • Project management
  • Clinical trial monitoring
  • Pharmacovigilance
  • Supervision and quality control of equipment and processes
  • Protocol writing
  • Tracking protocol deviations
  • Drafting of case report forms
  • Database creation and data lockup