Accutest India Pvt. Ltd. - a Contract Research Organisation (CRO) offering the services exclusively to Pharma/Chemical industries in the technical areas.

Clinical studies:

Accutest Research Laboratories (ARL) is committed to quality, time deadlines and economy. Clinical studies / trials are done as per in-house developed SOPs in accordance with ICH GCP guidelines and Indian GCP guidelines.

Selection of site, investigators
Protocol planning and development in consultation with the investigators
Designing of CRFs and other trial related (monitoring) documents
Development of clinical trial protocol related statistical aspects (study design, sample size, statistical power determination) and analysis (interim/final) by biostatistician
Data management
Training of investigators/staff for GCP guidelines and presentation of protocol at investigators meeting
Custom designed visit and site-specific clinical trial materials
Development of protocol-specific investigator instruction manuals and flow charts
Regular monitoring visits to the sites to resolve queries related to data and reporting of AE/SAE
Timely submission of study status reports to the sponsor
Professional commitment to high quality standards yet economical
A total sponsor-dedicated project management through selection of reputed centers and investigators.

Selection of world class, reputed sites and investigators from over 10 cities across the country.

ARL. is affiliated to Deenanath Mangeshkar Hospital and Research Center for Phase 1 studies
450-bed hospital Multi specialty hospital with state of the art infrastructure to carry out research

Laboratory services:
Biochemistry, Hematology, Lipid Profiles, Coagulation Studies, Diabetic profiles, Infectious disease serology, PCR & branch chain DNA amplification, Endocrinology.

Laboratory Reporting
Protocol-specific laboratory reports created as CRF formats Result transmittal tailored to meet needs of individual protocol

Phase I

Bioavailability, Pharmacokinetic drug interaction studies in compliance with GCP and GLP standards.
Twenty-four bed unit with ICU set-up
Advanced healthcare and analytical facilities needed to attract and motivate volunteers.
Specialized staff at the site: investigators, physicians, pharmacologists, pharmaceutical scientists, nurses and analysts.

Phase II & III

Study sites: Selection of sites most appropriate for the protocol
Investigators: Enrollment of investigators
Efficient development and speedy initiation of the project
Patient recruitment: Faster recruitment of the right patients more quickly
Anticipate and resolve issues, problem during the run of the trial keeping the standards of quality high
Ensure regulatory compliance keeping in mind “schedule Y” of drugs and cosmetics act.
Economy: Avoiding unnecessary expenditure to control cost

Phase IV / Post marketing surveillance

To satisfy regulatory requirements for a new labeling, advertising, efficacy or safety claim
Clinical Experience Trials to widen exposure and usage of the product
To support marketing claims and strengthen the product safety profile
Collecting new data: Indication, dosage, population, safety profile for presentations and publications
Extensive review of data and submission to regulatory agencies

Regulatory Affairs

Interaction with regulatory agencies

Direct interaction with FDA / DCGI with efficient communication saves crucial time for the project Knowledge of current regulations and understanding of regulatory environment ensures smooth and efficient drug development process

DCGI approvals for clinical trials

Review and preparation of efficacy and safety data from preclinical/animal / clinical studies for presentation to DCGI Faster approvals of clinical trial protocol from DCGI

IND / Drug registration. NDA, ANDA support

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