Dr. Sawant is a Ph.D in Analytical Chemistry and co-founded Accutest in 1998 after 12 years of experience in the …
Mr. Amrein runs the global commercial operations of Accutest. He brings 15 years of experience in Pharmaceuticals and Medical Devices …
Mr. Dubey is a certified Chartered Accountant & Company Secretary with an experience of 2 decades. He established, implemented and …
Dr. Pudage is a Ph.D in Analytical Chemistry from Mumbai University and is the President of the Bio-analytical department at …
Dr. Chavan is PhD in Biochemistry and has over 25 years of experience in the fields of bio-therapeutic molecules development, …
Dr. Gandhi is a Clinical Pharmacologist with around 14 years of experience. He has worked with major Indian pharma companies …
Mr. Talele (M. Pharm, MBA) holds 20 years of experience in the Drug Development Industry. He has worked in various …
Mr. Solankar is a post graduate in Pharmacology and has more than 15 years of experience. He is responsible for …
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 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 complied 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 our 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. We assess sites and their patient pools; suggest strategies for successful patient recruitment, leveraging our investigator database.Project management and planning
Our experienced project management team has successfully executed complex studies by accurately forecasting, identifying and mitigating project risks in different therapeutic areas and phases across various geographies. We emphasize both planning and execution and adhere to the highest standards of excellence to ensure high quality and on-time deliverables. The dedicated project manager is crucial between you and his project team.We work with SOPs designed for smooth communication and execution of complex studies.Clinical monitoring
Clinical Monitoring is the backbone of clinical trial and assures the quality of the trials. Our clinical monitoring team works closely with the project management team and the investigators to ensure excellent execution at all stages. Our CRAs, Sr. CRAs and Clinical Team Lead are familiar with industry best practices, local regulations. We provide exhaustive training in global guidelines, local regulations, study protocols and procedures, therapeutic areas including current changes like remote monitoring and risk based monitoring.Medical monitoring:
Our experienced and dedicated medical monitoring team provides 24x7 support to our 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.
Our qualified in-house trained and experienced physicians manage all medical monitoring and safety-related requirements:
We offer Clinical Data Management ("CDM") services in conjunction with the Clinical Trials services bundled or stand-alone. We have successfully completed CDM assignments, along with a biostatistical analysis for regulatory studies.Our CDM services offerings are further strengthened by:
Our complete documentation includes the data management plan, data entry guidelines, data handling guidelines, edit check specifications, obvious correction document and tracking sheet as per project requirements.Bio-statistics & Statistical Programming
Our medical writers have long track records in scientific and/or clinical research areas, ensuring that all medical writing requirements are met in an efficient and timely manner.
Our diverse platform covers
Our dedicated team manages all regulatory issues with the regulatory authorities and client expectations in a realistic and transparent manner in every county we operate, achieving faster approvals for all studies.
We provide cost-effective comparability solutions for biosimilars, novel biologics and non-biological complex generics.
Accutest Research Laboratories
Accutest Research Laboratories INC
103 Carnegie Center Drive
Princeton, New Jersey - 08540
Accutest Laboratorio De Pesquisa E Participações Ltd.
Rua Manoel da Nobrega
n° 1280, 10° floor, Paraíso
04001-902, São Paulo
Accutest Research Laboratories (I) Pvt. Ltd
A-31, Khairne MIDC
TTC Industrial Area
Thane Belapur Road
400 709 Navi Mumbai
Accutest Research Laboratories Netherlands B.V.
Claude Debussylaan 24,