Reliance Clinical Research Services has been set up by the Reliance Life Sciences Group to offer world-class clinical research services to pharmaceutical, biotechnology and medical device companies of the world. It has been established as a contract based research organization by the biotechnological subsidiary of Reliance Industries Limited. The headquarters of Reliance Clinical Research Services (RCRS) are situated in the Reliance Life Sciences facility in Navi Mumbai, India. RCRS also has business development offices in USA and UK. The services on offer by RCRS include Phase I-IV Clinical Trial Management and Monitoring, Pharmacovigilance, Biometrics, Pharmacokinetic & Pharmacodynamic studies, Cardiac Safety (thorough QTc) studies, Bioequivalence studies, Regulatory Affairs, Quality Assurance, Pre-clinical Development, Diagnostic Laboratory Services, Bioanalytical services, Medical Writing and Translation.

RCRS has a highly qualified staff to compliment the services offered which consists of Physicians, PhDs, and multi-disciplinary GCP trained staff. RCRS is the first Clinical Research Organization (CRO) in India to have its Central Pathology Laboratory accredited within the first two years of its inception by the College of American Pathologists (CAP). The Molecular Diagnostics Laboratory of RCRS has also been accredited by the National Accreditation Board for Calibration and Testing Laboratories (NABL) as well as the College of American Pathologists (CAP). RCRS utilizes its network of investigators from South East Asia, Eastern Europe and the Commonwealth of Independent States (CIS) countries to offer an array of services. RCRS has conducted studies in over 14 therapeutic domains including oncology, endocrinology, dermatology, hematology, gastroenterology, neurology, cardiovascular, vaccines, psychiatry, gynecology, infectious diseases, regenerative disorders, ophthalmology and nephrology.

Preclinical Services

The preclinical studies for RCRS are conducted at the Dhirubhai Ambani Life Sciences Centre in Navi Mumbai, India. Its preclinical services are essentially in-vivo efficacy and pre-clinical safety studies primarily for cell-based therapies, proteins and chemical entities. The studies are conducted in a state-of-the-art facility with an environmental monitoring system while ensuring compliance with OECD principles of Good Laboratory Practice. The preclinical services division of RCRS is capable of conducting general toxicology studies that include Acute Toxicology, Sub-Chronic Toxicity Studies and Chronic Toxicity Studies by Ooral and Parenteral Routes. Local tissue tolerance studies, mutagenicity studies and Bio efficacy studies of biotechnologically derived products are also part of the RIL preclinical services.

Phase I – IV Clinical Trials

RCRS has an over-60 bedded clinical facility in Navi Mumbai and an over-35 bedded facility at Bangalore for conducting Bioequivalence and Bioavailability studies. Along with using techniques like bar-coding for volunteers and biological samples RCRS also complies with regulatory requirements of US FDA, ANVISA (Brazil), MPA (Sweden), MoH (Turkey), MHRA (UK), MCC (South Africa), TGA (Australia) and DCG (India). For phase II to IV of clinical trials, RCRS offers services for project management, co-ordination of investigator meetings, clinical trial site qualification and monitoring, clinical trial monitoring and supplies management, pharmacovigilance, biometrics and quality assurance. The Biometrics Group encompasses the functions of Data Management, SAS Programming, and Statistics. The Quality Assurance team at RCRS offers Clinical Investigator Site Audits, Sponsor Audits, Systems Audits, Central Laboratory Audits, Clinical Trial Supply Audits, Adverse Event Reporting System Audits, Computer Systems Validation Audits, Database and Data Management audits and GLP Audits.

Diagnostic Laboratory Services

The diagnostic laboratory of RCRS is enrolled with CAP and Bio-Rad for external proficiency testing. RCRS provides a host of molecular diagnostic services in association with Reliance Life Sciences’ Molecular Diagnostics and Genetics testing laboratory which include DNA amplification of infectious diseases, HLA typing, Bcr/abl RT PCR along with Genetic testing, karyotyping, FISH and pre-implantation genetic diagnostics. The laboratory also offers facilities for testing flow cytometry, CD4 / CD8 / CD3 absolute, percentage, Oncology Leukemia, Lymphoma markers, Serology, HIV 1 & 2 Ab, HBsAg, HCV Ab, Syphillis Ab, CMV lgG / lgM Ab, HTLV 1 & 2 Ab (LlA), HIV Western Blot and Cytokine / chemokine levels.

Medical Writing

RCRS offers regulatory, marketing, clinical and educational document writing services including peer-review publications. SOPs, developing scientific posters and writing manuscripts are also on offer by RCRS. The RCRS team consists of physicians who hold expertise in developing documents in various therapeutic areas like oncology, cardiology, infectious diseases, ophthalmology, diabetes, neuropsychiatry and respiratory disorders. US/EU/ICH guidelines and regulations are followed by RCRS while preparing documents.

RCRS offers the Young Clinical Research Professionals Program (YCPP) and the Advance Diploma in Clinical Research as courses that focus on the responsibilities of sponsors, investigators, Ethics Committe personnel and other clinical trial players.