Everything in One Place
- 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
- 21 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
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.
- Bioanalytical services with 38 LC-MS/MS, 1 ICP-OES and 1 ICP-MS instruments
- Specialized solutions in pharmacokinetic and statistical analysis using Win-Nonlin and SAS
- Dedicated client specific project management for support and co-ordination
- Regulatory support including e-CTD compliant dossier submissions and resolving regulatory queries
- Assistance in seeking regulatory permissions
- Post study support for archiving of records and sample retention
- Assay bank of more than 900+ Bioanalytical methods, developed and validated in compliance with international regulatory requirements
- Vast experience of executing more than 3,000 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
- Consistent track record of successful inspections (100+) from prominent global regulatory bodies, including USFDA, ANVISA, EMA, WHO, DCGI, MCC, NPCB-Malaysia, FDA-Thai, ISP-Chile, MOH-Turkey and MOH-UAE
- Strict adherence to current GCP/GLP and applicable regulatory guidelines
Infrastructure & Facilities
- 10 clinical units with 400+ beds facilitating simultaneous conduction of multiple studies resulting in quick turnaround time
- Bio-analytical labs with 38 LC-MS/MS, 1 ICP-OES and 1 ICP-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
- Large and diversified database of 41,000+ volunteers including female, post-menopausal female and geriatric population
- Pool of latest and highly sensitive mass spectrophotometers, including API-6500, API-5500, Waters Xevo-TQS coupled with UPLC and ICP-OES
- Regulatory compliant archiving facility spread over 10,000 sq. ft.
- Ample storage facility for retaining samples at -20°C and -70°C
- Team of clinical investigators, analytical investigators, quality assurance, regulatory affairs, biostatisticians and project management professionals
Phase II – IV Clinical Development Services
Clinical trial feasibility and patient access planning
Project management and planning
Our experienced and dedicated medical monitoring team provides 24×7 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:
- AE and SAE reporting
- Medical query and its resolution to ensure protocolcompliance, accurate data collection and GCP compliance
- Regulatory reporting for safety issues as per local requirements
Clinical data management and biostatistics
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:
- SOPs which have been developed to meet local and global guidelines of CDM and the services in adherence to 21CFR Part 11
- Quality coding with thesaurus management system using WhoDRA and MedDRA
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
- Development of study design and study protocols
- Definition of study objectives and endpoints
- Sample size determination and randomization plan
- Preparation of statistical analysis plans, consistent with ICH guidelines
- SAS programming
- Statistical analyses and reporting of study results
- Production of tables, listings and graphs, in compliance with ICH guidelines
- Validated software: SAS® 9.2 and WinNonlin 5.0.1 for apt output
- Exhaustive discrepancy management
Medical writing & safety
Medical writing & submission
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.
- Protocol conceptualization, designing and preparation
- ICF designing
- Preparation of abstracts and research and/or review articles, short communications etc.
- Preparation of Posters
- Report writing in compliance with ICH E3 guidelines/applicable regulatory submission
- Site specific and country specific reports
Our diverse platform covers
- Pain management specialties
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.
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.
Services for Nutraceutical Companies
Market share of any nutraceutical product is proportional to evidence based research and to do so, industry look for experienced and capable partners to support this research. Accutest have the capability have the capability to manage study in stipulated time period and ultimately helping them to boost your overall marketing strategy.
Nutraceutical products which are backed by clinical data are adept to garner premium pricing from an increasingly knowledgeable consumer.The demand of rigor and extensiveness of clinical data are very high in a competitive market place.In order to meet the demand of this competitive market place, every Nutraceutical company needs a qualified partner to support and plan their clinical studies.
Any clinical evidences to claim can attract better market positioning. In order to meet the demand of today’s competitive market place, Accutest is the best CRO partner for every Nutraceutical company to satisfy product by supporting studies.
Accutest can offer you our wide array of services, that we are currently offering to support studies for nutraceutical companies.
USFDA inspected us 28 times and is endorsed to deliver the best Quality in Global CRO segment, wehavealso been awarded the “International Quality Summit Award in the GOLD category” by Business Initiative Directions, US based on customer voting. India INC. 500 award” for being one of the fastest growing company, “The Inc India Innovative 100 award” in recognition of smart innovation and ingenuity.
Propriety combination of product often use published date for making claims and we at Accutest can assist all the propriety medicine/ combination to substantiate claims through required, statistically significant studies.
We are expert in study conceptualization, planning, execution and report submission of nutraceutical studies. Accutest can provide services as bundled or stand alone as mentioned below:
1. Conceptualization of the study / studies
2. Calculating statistically significant sample size for the study
3. Designing the study with protocol development – protocol will include objective of the study, inclusion/exclusion criteria for study, investigations, statistical plan, etc
4. Conduct of the study at site level
5. Data mining, concluding and reporting study results
6. Selection of subjects from our database (utilizing our current database of 38,000+ healthy subjects)
We have database of healthy subjects (more than 38 K), diseased subjects (diabetology, cardiology, gastrology, psychiatry etc) and relevant doctors/ hospitals to complete such studies. We have successfully completed studies in the areas of dietary supplements, functional foods for Glycemic Index calculation.
Let the Accutest’s clinical development team of experienced managers and medical staff develops and manage your next nutraceutical study.
- OECD-GLP approved and GCLP compliant lab facility
- 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
- Biochemical Characteristics of biologics: intact mass, peptide mapping, di-sulfied bonding analysis, glycan analysis, N and –C terminal sequencing
- Physiochemical integrity of biologics
- Impurities present in formulation, quantification of mAb, HCP and HDC
- Immunogenicity testing for vaccines
- 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
President (Global Business Development)
Dr. Suhas Khandave
President (Clinical Services)
A global best-in-class Contract Research Organization offering comprehensive services along the whole drug development process to pharmaceutical, generics and biotechnology companies
CONTRACT RESEARCH ORGANISATION
Accutest is a global independent and internationally accredited Contract Research Organisation (“CRO”) founded in 1998. We are 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. We have a strong regulatory track record and numerous accreditations/approvals from global regulatory agencies.
Years consistent global track record
BA/BE studies successfully performed
ANDA filings using our services
Regulatory Inspections (Times)
NPRA Malaysia (5x)
MOH Turkey (1x)
Accutest Research Laboratories (I) Pvt. Ltd.
A-31, Khairne MIDC,
TTC Industrial Area,
Khairne, Navi Mumbai-400 709.
A-77, Thane – Belapur Rd, TTC Industrial Area, MIDC Industrial Area, Kopar Khairane, Mumbai, Maharashtra 400709
4th floor, The Grand Monarch,
Nr Seema Hall, Anandnagar Road,
Satellite, Ahmedabad -380059
101-103, 1st floor and 201-204, 2nd floor, Synergy square complex,
Krishna Industrial Estate, BIDC,
Gorva, Vadodara -390016