Clinical Trial Capabilities
Sapthagiri Clintrac’s Clinical Operations team conducts Phases I-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 staff thereby improving productivity, saving time and decreasing 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 expertises 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.
- 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 analyze 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 offers experienced Clinical Research Associates (CRA’s) to monitor and manage clinical trials. Site Initiation, monitoring and close out visits are run according to SOPs, Sponsors’ requirements and reporting methods, documented in the Clinical Monitoring Plan. Staff training includes Good Clinical Practice (ICH-GCP), Standard Operating Procedures (SOP’s), technology, scientific & medical topics, and updates on industry developments.
Our CRAs work closely with sites to collect clean data quickly. Clear SOP’s, responsibilities and good communications ensure consistency in working processes across the clinical trial CRA team.
Sapthagiri Clintrac provides monitoring of clinical trials. At each monitoring visit, according to project scope, CRA’s review:
- Protocol compliance
- Case Report Form (CRF) accuracy and completeness
- Serious Adverse Event (SAE) reporting to the required bodies
- Tracking of mandatory reporting to Ethics (IRB) & Regulatory authorities
- Enrolment & suitability of participants
- Filing and maintenance of source documents
- Investigational Product inventory and accountability records
- Compliance of investigator’s document file
Following each site visit, Sapthagiri Clintrac prepares a monitoring report in accordance with Sapthagiri Clintrac or Sponsor SOP’s as specified.
Sapthagiri Clintrac works closely with the sponsor during this process to ensure all data for the study is collected and reported, compliance with regulatory authorities and ethics requirements are met, and loose ends (if any), are resolved up for stakeholders.
An exclusive site management team, Sapthagiri SMO, shall continuously follow up with the investigator for patient recruitments and patient retention.
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.
- Access to Clinical specialists and networks
- Research Pharmacy support
- Controlled storage for Investigational Medicinal Products
- Biospecimen collection and processing
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
- Relabeling services
- Customs clearances
- Receipt and storage