Accutest Research Laboratories: Meet the Market Leader amongst Independent CROs

“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.

Why Accutest

• Global CRO
  Comprehensive drug development and testing services
• Truly Independent
  No stake or partnership with any pharmaceutical company
• Drug development and testing for chemical and biological molecules
  Partner to generic and innovator companies
• 17 years consistent global track record
  Leveraging infrastructure, equipment and experienced team through all challenges including First to File in the US
• International quality standards
  US FDA, WHO, EMA, ANVISA, DCGI, MCC and many more
• Competitive pricing
  Global best practices with delivery capabilities focused on key emerging markets.

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.

Services Offered
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.

• Clinical studies from proof of concept to global submissions in an ethical, efficient and regulatory compliant manner
• Customized studies for challenging drugs requiring complex designs and/or special attention towards safety parameters.
• Assistance in seeking regulatory permissions
• Post study support for archiving of records and sample retention

Expertise

• Assay bank of more than 550 Bioanalytical methods, developed and validated in compliance with international regulatory requirements
• Vast experience of executing more than 2,200 Bioavailability/Bioequivalence studies involving challenging clinical and bioanalytical parameters
• Competency in handling complex clinical trial designs (hormones, endogenous substances, elemental formulations and locally administered products) besides oral solids/liquid dosage forms
• Competency in handling different analytical challenges including pro-drug analysis, parent–metabolites simultaneous assays, chiral analysis, elemental analysis, hormones and endogenous substances

Infrastructure & Facilities

• 9 clinical units with 346 beds facilitating simultaneous conduction of multiple studies resulting in quick turnaround time
• Bioanalytical labs with 40 LC-MS/MS instruments
• Clinical pathology labs accredited by the College of American Pathologists (CAP) and National Accreditation Board for Testing and Calibration Laboratories (NABL), equipped to carry out tests for biochemistry, hematology, urine chemistry and serology

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
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.

Medical monitoring
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.

Data management
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.

Regulatory Affairs
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.

Biosimilars Services

• Cost-effective comparability solutions for biosimilars, novel biologics and non-biological complex generics
• Pharmacokinetics and pharmacodynamics
• Bioassay (i.e. potency determination) and immunological properties
• Biological activity (functional assays), in vitro and in vivo bioassays
• Multi-tiered approach immunogenicity assessment
• Anti-Drug Antibody (ADA) testing
• Neutralizing Antibody (NAb) testing
• Pre-clinical testing
• Cell banking- Master cell bank, working cell bank and ready to plate cell banks
• Mycoplasma testing
• Polyclonal monoclonal antibody production and immuno affinity purification
• Critical reagent preparation
• Drug and antibody labelling
• Stand alone study protocol/plans and study report review services

“We contribute to the well-being of humanity by being a partner in the drug development process.”