“Our mission to become the preferred CRO partner to pharmaceutical and biotechnology companies globally”
Accutest is a global independent and internationally accredited Contract Research Organisation (“CRO”) founded in 1998, offering services to customers around the world with operations in India, across Asia, and in Brazil. Accutest is the market leader amongst independent CROs, with the highest quality standards and quick turnaround times. They have a strong regulatory track record and numerous accreditations/approvals from global regulatory agencies.
Meet the Leaders
Dr. Satish Sawant, Co-Founder, CEO & Managing Director– Dr. Sawant is a Ph.D in Analytical Chemistry and co-founded Accutest in 1998 after 12 years of experience in the pharmaceutical field with Merck and Kopran. His earlier research work’ focused on the development of analytical methodologies for the assessment of bulk drugs and their marketed formulations. He has 18 national and international publications to his credit and is an active member of the Indian Pharmaceutical Association, a committee member of India’s FDA, and IDMA (Indian Drug Manufacturer’s Association). He is also a visiting faculty at Mumbai University.
Andreas Amrein, President– Amrein runs the global commercial operations of Accutest. He brings 15 years of experience in Pharmaceuticals and Medical Devices with Novartis and Abbott, where he was responsible for the Asia business of the Diabetes Care Division. Prior to Abbott, he had been working with Novartis for 11 years in business development/M&A, finance, marketing, sales, strategy in HQ, APAC regional office, China, Germany and Indonesia. Before Novartis, Andreas was a banker with UBS in equity research. Amrein is a Physicist (ETH Zürich), MBA (INSEAD) and a speaker and panelist at numerous conferences.
Phase I BA/BE Studies
Accutest is the partner of choice for all international pharmaceutical companies looking to execute Bioequivalence studies on various dosage forms at top quality, top speed and at competitive prices.
Infrastructure & Facilities
Phase II – IV Clinical Development Services
Clinical trials are integral part of Drug Development. Accutest runs end-to-end services for Phase II to IV clinical trials on small molecules, large molecules and medical devices with fully ICH GCP compliant operations.
Clinical trial feasibility and patient access planning
The clinical study feasibility involves analyzing key regulatory considerations, disease incidences and prevalence and practical implications of conducting clinical trials in a particular geography. It is an essential and critical component of any study set up, and their extensive network of clinical investigators and allied functions will assist you in the effective planning and identifying of the most efficient and rapid route of success.
Clinical Monitoring is the backbone of clinical trial and assures the quality of the trials. Their clinical monitoring team works closely with the project management team and the investigators to ensure excellent execution at all stages. Their CRAs, Sr. CRAs and Clinical Team Lead are familiar with industry best practices, local regulations.
Their experienced and dedicated medical monitoring team provides 24×7 support to clinical monitoring group and to the investigators, answering protocol and therapeutic area related queries. With the investigators it reviews the study protocol and the brochure, identifying and anticipating challenges during the execution of your study. In addition the medical monitoring team trains the clinical group to continuously improve the quality of execution of the trials.
They offer Clinical Data Management (“CDM”) services in conjunction with the Clinical Trials services bundled or stand-alone. They have successfully completed CDM assignments, along with a biostatistical analysis for regulatory studies.
Their dedicated team manages all regulatory issues with the regulatory authorities and client expectations in a realistic and transparent manner in every county they operate, achieving faster approvals for all studies.