• 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

• 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

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

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 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.

• 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 & 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

Therapeutic Experience

Our diverse platform covers

• Oncology
• Psychiatry
• Cardiology
• Nephrology
• Dermatology
• Ophthalmology
• Vaccine
• 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.

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.