- Global CRO
Drug development and testing services for chemical and biological molecules
- Truly Independent
No stake or partnership with any pharmaceutical company
- 17 years consistent global track record
Leveraging infrastructure, equipment and experienced team of 700+
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
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.
Vision & Mission
- 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 40 LC-MS/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 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
- Consistent track record of successful inspections (80+) 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
- 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
- Large and diversified database of 34,000+ 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 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 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 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.
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.
- 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
- 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
years consistent global track record
BA/BE studies successfully performed
ANDA filings using our services