Overview

Shankus medical and clinical research department focuses on facilitating novel and systemized research to improve healthcare. The department is capable of assisting organizations and clinicians alike in the creation of new healthcare delivery systems by providing facilities and teams specifically designed to support clinical trials and research.

The entire study cycle is covered by the department services; from archival to feasibility studies. The department also ensures that clinical trials are carried out under regulatory compliances and requirements, upholding the hospitals high ethical standards and safeguarding the subjects rights, well-being, and safety.

Expertise

The Hospital has been providing high-quality healthcare in a wide range of specialties for more than five years; the resultant medical expertise and high standards carry over to the clinical research department. Some of the key specialties include General Oncology services like Surgery for Head and neck cancer, ENT and Skull base surgeries, Breast, Ovarian, Cervical Cancer, Medical and surgical Gastroenterology, Chemotherapy and blood cancer, Pediatrics and neonatology, urology, nephrology and other essential critical and emergency services. Some of the key features of the clinical research department include dedicated with systematic integrity for research ethics and data quality, an institutional ethics committee with DCGI/CDSCO recognition. The department also has Scientific Committee assistance for pharma-sponsored, investigator-initiated studies. Support to achieve Quality standards of ICH GCP, Schedule Y, ICMR and applicable national and global guidelines.

Services

With a dedicated team and facilities, the department provides in-depth support to clinical trials from various clients and different therapeutic areas. The clinical trial studies mainly include Phases I, II, III and IV along with PK/PD studies, Investigator-initiated trials, and protocol development for research questions by in-house residents/Fellows.

The department also handles in-House database & study setup, clinical trial data entry and validation, electronic source documentation, query handling and resolution, and supports the study teams efficient handling of databases. The department also conducts the pre-clinical trial site preparation which includes the feasibility of the study and on-site trial management

Clients

The clinical research department has collaborated and worked with several organisations across several medical industries. Our major esteemed ongoing clients include Axis Clinicals and Lambda Therapeutic Research Limited and upcoming clients are Cliantha Research and COD Research group.

We also have an investigator-initiated study from the HNCOG group on Head and Neck cancer. Currently, the Medical Director of the hospital also initiating studies based on protocol development by the fellows in the Head and Neck cancer department.

The currently ongoing studies from our clients include

Study Name

Indication

Sponsor/CRO

Study Phase

Study Status

Bevacizumab

Lung Cancer

Axis

III

Ongoing

Curcumin & Metformin

Head & Neck Cancer

Narayana Foundation

IIb/III

Ongoing

Doxorubicin

Ovarian Cancer & Breast Cancer

Lamda

PK Study

Upcoming

Pertuzumab

Breast Cancer

Lambda

PK Study

Upcoming

Docetaxel Injection

Breast Cancer

Lambda

PK Study

Upcoming

Denosumab

Bone Metastases

Lambda

IV

Upcoming

Goserelin

Breast Cancer

Lambda

PK Study

Upcoming

Facilities

The clinical research department has access to medical infrastructure, facilities, and expert medical and supporting staff. The facilities include a dedicated ethics committee and infrastructure, central lab, data management facilities, NABH Approved Facility, Archival facilities, and GCP-trained dedicated staff.

The department also has a dedicated clinical pharmacy and drug storage facility. The clinical research department has been backed by a strong expert clinician with ICU & MICU Facilities from the hospital.

Research Team

The department comprises a highly competent and dedicated professional research team with experience in the field and across the facilities in conducting clinical trials. The team has a Research scientist heading the department who has experience in head and neck oncology. The department is managed by a professional experienced in clinical trials with a pharmacy background along with clinical research coordinators, phlebotomists and dedicated nurses for the different studies. The expertise and experience of the medical professionals from Shankus hospital also add to the teams strength.

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