ICBio Clinical Research Pvt. Ltd.
Winner of India 5000 Best MSME Awards 2024
ICBio Clinical Research Pvt. Ltd.
Winner of India 5000 Best MSME Awards 2024
Details
ICBio Clinical Research Pvt. Ltd.
Private Limited Company
Hospital and Diagnosis Instrument
Contract Research Organisation - Clinical Research Solutions to Domestic & International Pharmaceutical & Biopharmaceutical Companies.
2008
54
Bengaluru (Bangalore) Urban
Bengaluru - 560097
Karnataka
Introduction
ICBio Clinical Research Pvt. Ltd. provides specialized services in Bioavailability/Bioequivalence studies, Phase I-IV clinical trials, pharmacovigilance, and clinical safety services. The clinical facility is equipped with five independent air-conditioned CPUs, ICU facilities, and access-controlled UPS backup, allowing for the simultaneous conduct of multiple studies, which results in quick turnaround times. The bio-analytical facility is outfitted with state-of-the-art equipment, including SCIEX 4500 Series, Shimadzu 8040 & 8050 mass spectrometers, and PerkinElmer ICP-MS, with developed and validated methods for 150 molecules. The organization also maintains a large database of study volunteers.
With exceptional scientific expertise and the ability to handle complex studies, the ICBio team supports various regulatory agencies such as DCGI, ISP Chile, EMA, USFDA, MHRA, Health Canada, and TGA. The company is approved by DCGI, CDSCO, EMA, ISP Chile, MOH Kazakhstan, and operates a NABL Accredited Central Laboratory integrated with LIMS. Accreditation from NPRA Malaysia and ANVISA Brazil is currently in progress. The highly experienced staff at ICBio is dedicated to delivering outstanding clinical research services to sponsors, offering considerable cost savings, and is recognized in India for being a cost-effective, high-quality CRO.
ICBio Clinical Research Pvt. Ltd. was established by a group of experts committed to providing quality, knowledge, and expertise. The organization offers comprehensive, integrated, end-to-end clinical research solutions both in India and globally. These services include Clinical Trials (Phase I-IV), BA/BE studies, Clinical Endpoint studies, and quality research solutions for studies ranging from PK studies in healthy volunteers to patient trials for generics and NCEs. The company serves clients in industries such as pharmaceuticals, biopharmaceuticals, herbal/nutraceuticals, medical devices, and cosmetics and personal care, providing customized solutions to meet the needs of sponsors throughout the clinical research spectrum.
They aims to become a one-stop clinical trial services provider, helping clients streamline all aspects of human clinical trials. By offering high-quality services, ICBio seeks to be the preferred research partner in drug development, assisting worldwide clientele in innovator, biosimilar, and generic drug development programs.
CEO & Founder Director Details
Dr. Harisha S
Post Graduation
Dr. Harish S, the CEO and Founder Director of ICBio Clinical Research Pvt. Ltd., is a pioneering figure in India's clinical research industry. With a post-graduate degree in Biochemistry from Kuvempu University and a doctorate from Miami University, Dr. Harish's journey as a first-generation entrepreneur began as a corporate trainer. Today, he leads one of the country's foremost Contract Research Organizations (CRO).
With over two decades of experience, Dr. Harish has coordinated all phases of global and domestic clinical trials, including BA/BE studies. His expertise spans biochemistry, bioinformatics, clinical research, and R&D. He has also played a key role in developing and revising clinical trial-related SOPs, protocols, and budgets for both CROs and Ethics Committees.
In 2005, Dr. Harish founded the ICBio Institute for Clinical Research, which offers specialized courses tailored to the clinical research industry's needs. These programs are designed to train students from medical, pharmacy, life sciences, and nursing backgrounds, helping them meet the growing demand for professionals in the pharmaceutical, healthcare, life sciences, and biomedical sectors. As a key link between academia and industry, Dr. Harish has personally trained hundreds of professionals in ICH-GCP, working with pharmaceutical companies, CROs, SMOs, and clinical sites.
He has served as Chairman of the Board of Examiners and as a member of the Board of Studies in Clinical Research at the University of Mysore. Dr. Harish's contributions to the establishment of several CROs in India have been instrumental in advancing clinical operations, business development, and industry processes. His leadership has driven innovations such as faster enrollment and retention strategies, as well as the implementation of new technologies and processes.
Dr. Harish maintains strong professional connections with global experts in the fields of CRO, SMO, bioinformatics, and biotechnology. He has also made significant contributions to academic research, with experience in structure prediction and pattern searching. Over the years, he has published 84 research papers, authored four books, and edited seven more.
Known for his enthusiasm, hard work, and positive attitude, Dr. Harish excels in public relations, teamwork, and communication. His dedication to excellence under pressure and his ability to lead teams have made him a respected figure in the clinical research industry.
