Clinical Research Service

Clinical Trial Capabilities

Sapthagiri Clintrac is engaged in Phase I- Phase IV Clinical Trials for pharmaceutical, medical devices and biotech companies, whilst maintaining the highest standards of ethics, quality and confidentiality.

To ensure our clients receive quality monitoring services in compliance with the applicable regulatory guidelines, we provide comprehensive training and Development Programs to our Clinical Research Associates (CRAs) and other core study team thereby Improving Productivity, saving time and reducing costs.

We have an in-house Clinical Operations team that is trained and with membership to the Institute of Clinical Research and/or Association of Clinical Research Professionals. These are assigned to monitor specific trials. Monitoring ensures all trials comply with ICH-GCP and are thereby being conducted to high ethical standards whilst collecting high quality data.

Our Clinical Research professionals’ strong therapeutic, regulatory, and operational expertise’s continuously solve the challenges that arise during all clinical projects.

Our key services include:

  • Feasibility, Regulatory perspective and Strategic planning
  • Project Management
  • Clinical trial and site management
  • On Site monitoring
  • Patient recruitment

Sapthagiri Clintrac conducts clinical trials through the Facility (Phase I) benefit operationally from the following:

  • Support, guidance and scientific input from the point of setting the question and trial design to the final report.g
  • Project management, financial administration and trial coordination.
  • Clinical trial and site management
  • Full range of in-house SOPs and SOP writing to adapt to sponsor/protocol requirements.
  • Centralized budget, staff and resource management
  • Fully integrated clinical trial laboratory and coordination with other laboratories and clinical services.
  • Trial monitoring and quality management, regulatory support and safety reporting

Site Identifications and Feasibility Visits:

Sapthagiri Clintrac identifies qualified principal investigators quickly from its site database, our experience, site accreditation, and where appropriate, a site feasibility visit. We analyse the

Feasibility of conducting clinical trials at sites. Recommendations are based on criteria including:

  • Investigator interest
  • Number of eligible patients expected to recruit.
  • Concurrent trial workload, particularly at recruitment stage
  • Previous experience in similar clinical studies
  • Recruitment & retention in prior clinical trials
  • Site personnel study experience and training
  • Trial-required facilities such as laboratories and pharmacies
  • Trial-specific equipment e.g. measuring and imaging apparatus
  • Quality assurance processes
  • Additional sponsor requirements

Clinical trials, like all projects, require quality data, on time and within budget. Sapthagiri Clintrac plans comprehensively, defines responsibilities, analyses risks, agrees on a communications program, and sets a schedule for action. This is documented according to sponsor requirements.

During the course of trial planning and monitoring, clinical project managers keep clients informed of project milestones. Good project management identifies potential hurdles early on, when they are easiest and cheapest to resolve.


Sapthagiri Clintrac Private Limited has one of the largest state-of-the-art clinical research trial facilities of any private hospital in the nation. The 15,000-square foot clinical research trial facility is a testament to the Medical Center’s commitment to remain in the forefront of applying research discovery to patient care. The Sapthagiri Hospital provides a strong scientific, clinical and administration infrastructure to support these investigations. Core facilities funded by GD group provide specialized clinical research trial services in a cost-effective, efficient manner.

Featured Services

Feasibility of conducting clinical trials at sites. Recommendations are based on criteria including:

  • Access to Clinical specialists and networks
  • Research Pharmacy support
  • Controlled storage for Investigational Medicinal Products
  • Bio specimen collection and processing
  • Archival

Clinical Trial Supplies

As per regulatory requirements for IP management we have put in place specific SOPs and work documents for compliance with GCP norms. Our facility is equipped to maintain controlled ambient and 2°- 8°C temperature ones with a separate quarantine section. Round the clock temperature monitoring and adequate power back-up ensure that the temperature is always maintained within limits.

Key services include

  • Storage of investigational products and ancillary supplies
  • Storage of non-IP study materials
  • Returns and IP destruction
  • Relabelling services
  • Customs clearances
  • Receipt and storage