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