Prince Aly Khan Hospital

Clinical Research

Clinical Research unit at Prince Aly khan Hospital, Mumbai, India

PAKH has a vibrant Research department with an area of around 700 sq ft carrying out clinical and community based research. Under the leadership of the Director of Clinical Research, Dr. Tapan Saikia, PAKH has conducted around 80 different clinical trials since 2005. It is certified by the Scientific and Industrial Research Organization (SIRO) since 2009. The very active (Institutional Ethics Committee (IEC)) is NABH certified since the year 2018.  The Research and Clinical Trial Unit (RCTU) is about to move and will have a designated floor in the new outpatient department building for the Research room, Consent Room, Ethics committee Room and IP storage. There is a well-equipped and accredited high standard laboratory, and designated refrigerators and deep freezers with electricity backup. The IP Storage room has a 24/7 Smart electronic Temperature monitor.

The CRU comprises of
  • Clinical Research room with patient examination area
  • Work station for Study Coordinators
  • Monitoring area for study monitors
  • Consent Room
  • Diploma In Tropical Medicine & Health

IP Storage room is placed Opposite to the clinical research room with Electric back up and with 24/7 Smart temperature Monitor.

Site has a chemotherapy day care on first floor in the opposite building( In patient Department) with Bio-safety cabinet (Laminar flow), All oncology drugs are being prepared under the laminar flow. There are total 17 Beds for the patients, the same facility is being used to administer the IP and chemotherapy for research subjects.

Clinical research Staff are ICH-GCP trained and certified and their roles are listed below.

Investigators:
Investigator is responsible for the all the study activities through-out the study.

Obtain informed consent, Assess eligibility, CRF review-Entry- Query resolution, Medical decision and management, Collect medical information, Vital Sign, Physical examination, Assess adverse event, IP Administration, Collect lab samples, Maintain Essential documents.

Clinical Research operation manager and Senior coordinator:
Oversight of PAKH Clinical research studies and staff, Support all research staff with their task. Maintain essential documents, Manage submission to IEC and regulatory authorities.

Maintain legal and financial documents, Ensure Appropriate invoicing to sponsor,

Ensure appropriate processes for Research covered procedure vs patient standard of care. CRF entry, Query resolution, IP Administration.

Clinical research coordinator: 
Make CRF entries, Resolve queries, maintain patient research document. Manage IP receipt/Return, Temperature management.

Pharmacist: 
Prepare and dispense IP/ unbinding procedure.

Study Nurse:
Medical information (Vital signs, collect adverse events), collect Lab samples.

Phlebotomist:
Safety Lab sample collection, PK, PD or Immunogenicity sample collection.

The Clinical Research unit is led by Dr.Tapan Saikia, Head Medical oncology and Bone marrow transplant physician. Director Research, PAKH.