Research and Academics

The institute participates in clinical trials with the sole aim of staying at the forefront in orthopaedic research in order to provide the best and most up to date treatment for our Patients and to make a contribution to medical progress and academics.

With these aims, the department adheres to the highest standards in clinical research by strictly complying with good clinical practices and international conference on harmonization (ICH) Guidelines.

The department maintains its standard through periodical internal audits to ensure and maintain a strict protocol adherence, providing An adequate quality and full compliance with local and international standards through the study processes. The department also participates in training And research methodology by conducting yearly seminars on evidence based medicine and workshops in advanced good clinical practice. The department divides its research data into clinical and academic research to increase the efficiency and quality of data.

Over-view of clinical research activities

• The department has developed its own Standard Operating Procedures (SOPs) to ensure the strictest adherence to protocol.
• Maintaining training files of all the research team members to ensure they are GCP trained and qualified.
• Timely calibration of equipment including centrifuge, weighing machine, stadiometer, sphygmomanometer, thermometer, etc.
• Upgrading the X-ray and DXA machines on timely basis. A regular quality control and quality assurance of these equipment is performed by the research coordinators.
• The research patients’ source files are maintained and the source documentation is completed on a timely basis. The data is kept under lock and key in a secure place with limited access to maintain confidentiality of the data.
• Notifying the Ethics Committee by submitting a periodic progress report of the trials conducted. Other submissions including the DCGI approvals, protocol and ICF amendments, serious adverse events, etc are done on timely basis thus keeping the EC updated.
• Temperature logs are maintained for the deep freezer where the investigational product (IP) is stored to ensure there is no temperature excursion occurring at the site.
• A check list of all the investigational products, laboratory kits, the packaging material, temperature data loggers is maintained at the site. This helps to locate IP box and identify used or expired kits or boxes.
• Maintaining the patient visit schedules as per protocol. The patients are followed and a reminder call 3 days prior and then again one day prior to their scheduled visit has helped us achieve 0% lost to follow-up and missed visits at our site.
• Strict adherence to this schedule is a part of our protocol and this has helped the sponsor to have a clean and valid data from our site.
• Telephone log is maintained which provides details of the time and date of the call, person called and issues discussed.