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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
  • 16 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

About Us

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, Brazil and Mexico. Accutest is the market leader amongst independent CROs, with the highest quality standards and quick turnaround time. We have a strong regulatory track record and numerous accreditations/approvals from global regulatory agencies.

Vision

Global best-in-class Contract Research Organization offering comprehensive services along the whole drug development process to Pharmaceutical, Generics and Bio-Technology companies

Mission

Become the preferred CRO partner to pharmaceutical and bio-technology companies globally, by means of recognition, scientific competence, professional approach, timely delivery, cost effectiveness and quality excellence

Values

Contribute to the well-being of humanity by being a partner in the drug development process, along with pharmaceutical companies

Leadership Team

Our Services

Bioavailability/Bioequivalence > Services

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
  • Bio-analytical services with 44 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
Bioavailability/Bioequivalence > Expertise
  • Assay bank of more than 470 Bio-analytical 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 Bio-analytical parameters
  • Competency in handling complex studies in clinical trial designs (difficult drugs like hormones, endogenous substances, elemental formulations and locally administered products) besides oral solids/liquid dosage forms
  • 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 (70+) from prominent global regulatory bodies, including USFDA, ANVISA, EMA, WHO, DCGI, MCC, MOH-Turkey, MOH-UAE, FDA-Thai, ISP-Chile, NPCB- Malaysia.
  • Strict adherence to current GCP/GLP and applicable regulatory guidelines
Bioavailability/Bioequivalence > Infrastructure & Facilities
  • 9 clinical units with totally 346 beds facilitating simultaneous conduction of multiple studies resulting in quick turnaround time
  • 4 Bioanalytical labs with a total of 44 LC-MS/MS machines accredited by the College of American Pathologists (CAP) and by the National Accreditation Board for Testing and Calibration Laboratories (NABL), equipped to carry out tests for Biochemistry, Hematogram, Urine Chemistry and Serology
  • Large and diversified database of 34,000+ volunteers; including female (4,400); post-menopausal female (1,700) and geriatric population (1,000)
  • Pool of latest and highly sensitive mass spectrophotometers, including API-6500, API-5500, Waters Xevo-TQS coupled with UPLC and ICP-OES
  • Availability of replicate platforms of same sensitivity of the LC-MS/MS, enabling efficient and quick handling of larger studies with optimum assay transfer and validation time
  • 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, Bio-statisticians and Project Management professionals

Clinical Trials are integral part of Drug Development. Accutest runs end-to-end services for Phase II to IV clinical trials on small molecules, big molecules and medical devices with fully ICS and GCP qualified 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 resolving 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 back-bone 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 best in class execution at all stages. Our CRAs, Sr. CRA and Clinical Team Lead are familiar with industry best practices, local regulations. We provide exhaustive training in 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:

  • AE and SAE reporting
  • Medical query and its resolution to ensure protocol compliance, accurate data collection and GCP compliance
  • Regulatory reporting for safety issues as per local requirements
Clinical Data Management and Biostatistics

Data Management

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 Bio-statistical analysis for regulatory studies commissioned by the Drug Controller General of India (“DCGI”) and Case Report Form (“CRF”) designing and Bio-statistical analysis projects for Japanese clients.

Our CDM services offering are further strengthened by the following:
  • Oracle Clinical - the industry standard clinical data management system
  • 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

We offer Bio-statistical analysis and statistical programming including:

  • 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
  • Assiduous double data entry
Medical Writing & Safety

Medical Writing & Submission

Our medical writers have long track records in scientific and/or clinical research areas, ensure that all medical writing requirements are met in an efficient and timely manner.

  • Protocol conceptualization, designing and preparation
  • CRF designing
  • 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
Therapeutic Experience

Our diverse platform covers

  • Oncology
  • Psychiatry
  • Cardiology
  • Nephrology
  • Dermatology
  • Ophthalmology
  • Vaccine
  • Biosimilars
  • Pain Management specialties

With our vast and rich experience we offer and specialize in late phase testing services to conduct complex patient based PK studies

Regulatory Affairs

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.

Biologics Services

We are a leading CRO providing cost-effective end to end solutions for analytical characterizations of novel biologics and comparability solutions for biosimilars (protein therapeutics intended to substite existing branded biologic products).

  • Complete physico-chemical characterization as per relevant guidelines to meet the applicable regulatory requirements
  • BioAssay (i.e. potency determination) and immunological properties
  • Customized studies enabling pre-clinical in vitro comparability testing
  • Pharmacokinetic (PK) and pharmacodynamic (PD) assessments in animal and human samples
  • PK, PD, immunogenicity and other safety/efficacy parameters testing for investigational biopharmaceutical drugs through clinical studies incl. patient/volunteer/data management
  • Custom assay design, method development, validation and transfer to test APIs, new biologics and generic biologics
  • Biological Activity (Activity/Potency Assays), In vitro and In vivo bioassays
  • Multi-tiered approach immunogenicity testing
  • Anti-Drug Antibody (ADA) Testing
    • Binding Antibody Testing (Screening and confirmation)
    • Enzyme-Linked Immunosorbent Assay (ELISA)
    • Standard sandwich ELISA
    • Bridging ELISA
    • Surface Plasmon Resonance (SPR; BioRadProteOn XPR36)
  • Neutralizing Antibody (NAb) Testing with Blocking Assays
  • Related to mechanism of action of biologics
  • Receptor Binding
  • Cell based functional assays
  • Pre-clinical testing
  • Biochemical Characteristics of Biologics
    • Size, concentration, pH and Osmolarity
    • Identity - (N-terminal, C-terminal, peptide mapping, immunoblots, bioassays)
    • Purity (1D/2D SDS-PAGE, HPLC, immunoblot, DNA, endotoxin, viral (Bioburden))
  • Physiochemical integrity – Biologics
    • Impurities from aggregates and degraded products
    • Post-translational modifications (glycosylation, acylation, phosphorylation, etc)
    • Stability studies

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years consistent global track record

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BA/BE studies successfully performed

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employees

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ANDA files using our services

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Regulatory Inspections / Approvals (times)

International Addresses

GLOBAL

Accutest Research Laboratories Baarerstrasse 14
6300 Zug
Switzerland
Email:business@accutestglobal.com

USA

Accutest Research Laboratories INC 103 Carnegie Center Drive
Suite 300
Princeton, New Jersey - 08540
USA

Brazil

Accutest Research Laboratories Rua Cassiano Ricardo,
483 – CEP. 04640.020
São Paulo
Brazil

India

Accutest Research Laboratories (I) Pvt. Ltd
A-31, Khairne MIDC
TTC Industrial Area
Thane Belapur Road
400 709 Navi Mumbai
India

Mexico

Accutest Research Laboratories Mexico S.A. de C.V. Andres Teran 1125,
Colonia Chapultepec Country,
Código postal- 44620
Guadalajara, Jalisco
México

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