About Accutest Research Laboratories India Pvt Ltd
Accutest is a full service clinical research organization with a core strength in BA/BE & PKA studies and Formulation Development. We have three centers, Mumbai, Pune & Ahmedabad spread over a total space of 28000 sq ft. Each center has a well equipped Clinical Pharmacology Unit, Clinical Pathology laboratory and state of the art Analytical Laboratory. To cater to the increasing demand, Accutest’s Mumbai facility is currently being expanded to have a total capacity of 160 beds.
In 2005, we established our presence in Japan, the world’s second largest pharmaceutical community. Our Japanese office is aimed at providing a specialist interface between East and West. Both the team members are native Japanese experts, possessing first hand knowledge of Japanese language, culture and industry practices. Being located in Japan the team is able to rapidly respond to client requirements both locally and internationally.
With a team of 215 professionals and 200+ studies across the therapeutic areas, Team Accutest has come to be recognized as an efficient & committed partner in clinical research. It was adjudged as “India’s a Best CRO 0f 2005 in Clinical Research Outsourcing” by Proximare, one of the leading management consulting firms based in Princeton, USA. Proximare chose the best CRO award after carrying out a comprehensive and neutral analysis of India’s clinical research industry, including 33 CROs.
All the activities related to the execution of Bioavailability studies are performed under one roof at Accutest. The following Divisions are available:
· Business Development (initial contact for preliminary protocols and quotes, as well as Confidentiality Agreements and Study Contracts)
· Project Management (includes a Dispensing Unit and Medical Writing group)
· Clinical Division (including a group for study medication and biological samples)
· Biometrics and Data Management
· Bioanalytical Services (GLP accreditation)
· Quality Assurance
Foray into Formulation Development
Having established our credentials in the clinical research, we have now charted out an ambitious growth plan for ourselves to emerge as “The Complete Partner in Drug Development Process”. As a first step towards this goal, we have set up a Formulations Development center, which commenced its operations from September 2006. By integrating various services under one roof, we are aiming to provide a complete resource that enables our clients to progress from pre-formulation to clinical trial quickly, safely and cost-efficiently.
Our Formulations Development team of 16 scientists undertakes work on new active substances, generics and reformulation of existing products and offers following services:
1. Pre- Formulation
2. Formulation of wide variety of dosage forms
3. Manufacture of batches for stability testing
4. Scale up and production of pilot batches
5. Process validation and technology transfer
The dosage forms include Solids, Liquids and Semi-solids dosage forms as well as medical devices. The facilities is equipped with technologies for Sustained release, Surge release, Controlled release, Hot melt filling of capsules, Aqueous & organic film coating and Active coating of tablets, granules and capsules.
Profile of Our Services
1. Bioavailability, Bioequivalence and Pharmacokinetic studies
2. Clinical Project management (Phase 1 through Phase 4 trials) including statistical analysis
3. Data management & biometrics
4. Regulatory affairs
5. Quality Assurance
7. Medical writing
8. Laboratory services
9. Herbal Analysis
10. Formulations Development (From September 2006)
1. Bioavailabilty & Bioequivalence Studies
These include studies with
· Fasted/fed conditions
· Immediate/modified-release preparations
· Interaction studies
· Various routes of administration
· Healthy volunteers/special population
With a continuously updated list, our analytical laboratory offers highly selective and sensitive validated methods for assay of drugs/ metabolites and endogenous compounds from biological matrices using LCUV, LCFL, LCECD and LC-MS/MS-6 techniques, Pharmacokinetic & statistical data evaluations, reporting of study results and archiving of all study related data. We use variety of approaches including Fluorescence HPLC detection, electrochemical detection and triple quadruple mass spectrometry. Our expertise in rapid method development and validation allows us to offer timely and cost-effective analysis of samples.
At each of the three facilities in Mumbai, Pune & Ahmedabad, we have
· Independent Clinical Pharmacology Unit (CPU)
· Independent State of the Art Analytical Laboratory with 16 LC MS/MS machines incl a Thermofinnigan & Waters machines
· Independent In-house Pathology Laboratory
· Well-defined Areas for different activities in CPU
· Independent Quality Assurance department reporting directly to the Directors.
· More than 70 validated Analytical methods
· About 2500 - 5000 volunteer data bank
· GCP trained clinical research professionals
· Well documented Qualification / Calibration program.
· UPS back up for critical operations
· Biometric registration system for Volunteer enrollment
· Total capacity of 198 Beds in CPUs
2. Clinical Trials Project Management
A team of 25 handles the clinical trials projects. A project manager leads a team of Clinical research associates (CRAs), Data manager, Safety monitors and Quality assurance auditors, which is assigned, to each project. The Project management team is responsible for:
a. Investigational sites & Investigators: Selection, initiation & monitoring visits
b. Protocol planning & development
c. Presentation of Protocol at investigators meeting
d. Designing of Care Record Forms (CRFs), Informed Consent Forms (ICFs), Investigator manuals & other documents
f. Investigational materials management
g. Investigators’ & Staff training on GCP guidelines
h. Source data verification at sites
i. Safety management including Adverse events/ Serious adverse events handling
j. QA audit visits
k. Close out visits
We have a total of 16 clinical trials of various phases to our credit.
3. Data management
Our Data Management team is an efficient group of Data managers, Biostatisticians, Medical writers and Programmers capable of handling electronic, paper, web based and other forms of data. Our data management processes are compliant with 21 CFR Part 11. Data entry is done based on International or Proprietary coding using SAS/ SPSS. The data input entry is done by double entry till the preparation of final data.
4. Regulatory Affairs
With the knowledge of current regulations, understanding of regulatory environment and regular & direct interaction with FDA & DCGI, our Regulatory Affairs team is able to help procure approvals for conducting clinical trials faster. The team is responsible for:
1. Review & preparation of regulatory dossiers
2. Acquiring all the necessary licenses
We provide complete dossier for NDA, ANDA submission to the FDA under the Certificate of Suitability (COS) or European submission.
5. Quality Assurance
Our Quality assurance team undertakes various audits, such as those of systems, investigator sites, documents, data management & biometrics and laboratories to assess the compliance with the GCP & GLP guidelines. The team is independent of clinical operations team and ensures that the guidelines are strictly adhered to and recommended improvements are implemented. The QA team reports directly to the management. They also coordinate the development and implementation of all internal SOPs.
Timely documentation and reporting of an adverse event or serious adverse event (AE/ SAE) to the sponsor and the regulatory authorities is a critical function. Our clinical management team efficiently handles this.
7. Medical writing
Our project team has expertise in Protocol designing, Investigator Brochure, CRF and Informed Consent Form (ICF) design and review, statistical and medical report writing, safety and efficacy report writing as per ICH and other regulatory requirements.
8. Herbal Analysis
We have developed competency in screening herbal medicines for their content & quality. We help the client in choosing right raw material and/or extract from cultivation stage through harvesting to marketing.
Our Work Experience
A. No of BA/ BE studies done: 300
a. Domestic: 152
b. International: 148
B. No of Clinical Trials done: 16