Clinical Research Capabilities Bioavailability & Bioequivalence - - PowerPoint PPT Presentation

Clinical Research Capabilities Bioavailability & Bioequivalence Studies

Clinical Research Division

CLINICAL RESEARCH SERVICES

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VIMTA STRENGTHS

• Experience – 32 years of track record in supporting

Pharma & Life Sciences industries Pharma & Life Sciences industries

• A Truly Independent CRO – Not affiliated to any Pharma or Life

Sciences organization

• Core Value – Integrity of service through honesty, responsibility and

uncompromising devotion to Quality

• Strong Regulatory Compliance – Long standing experience in working

as per different regulatory frameworks One-stop-shop for testing your generic pipeline

• One-stop-shop for testing your generic pipeline
• 900 + knowledgeable, experienced, motivated and committed team
• Effective and Efficient Project Management

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Bioavailability & Bioequivalence Studies

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REGULATORY AUDIT EXPERIENCE

REGULATOR

• NO. OF INSPECTIONS

DCGI (India) 4 DCGI (India) 4 FDA (USA) 10 MHRA (UK) 2 BfArM (Germany) 2 ASNM (France) 2 WHO 4 DRAs of Denmark, Portugal & 1 DRAs of Denmark, Portugal & Sweden* 1 MCC (South Africa) 2 ANVISA (Brazil) 2 NPCB (Malaysia) 1

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BA/BE SERVICES

• Full service for BA/BE studies (1) In healthy volunteers &

(2) In patients (2) In patients – Study designing & protocol development – Method development & validation – Pre-study approvals for project initiation – Project execution as per protocol and standard procedures – Pre & post project regulatory support – Statistical data analysis Statistical data analysis – eCTD submission

• Standalone services (Clinic/Bioanalytical/clinical Lab)

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EXPERIENCE

• Study designing & protocol preparation

Cross over, parallel, steady state, average – Cross over, parallel, steady state, average bioequivalence (full/reference replicate designs)

• Testing of various dosage forms

– Tablets, capsules, orally disintegrating strips, gels, oral solutions, dermal patches and injectables solutions, dermal patches and injectables

• Execution of studies with large sample size
• Over 350 validated bio-analytical methods

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EXPERIENCE

• > 1700 BA/BE studies for customers across the globe
• Successfully contributed to more than 120 ANDAs

and 505.B(2) applications in regulated markets and 505.B(2) applications in regulated markets

• Submissions to regulatory agencies:

Regulatory Agency Studies conducted since

• No. of pivotal studies

conducted so far

DCGI (India) 1994 >400 USFDA 2000 >300 USFDA 2000 >300 EU 2001 >50 WHO 2000 >15 Others (Health Canada, TGA, MCC, etc.) 2000 >50

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IT POWERED PROCESSES

• Biometric solutions for identification of volunteers and cross

Biometric solutions for identification of volunteers and cross participation status

• Audio-Video recording of consent process
• MedDRA for Adverse Event Coding
• Analyst software version 1.4.2 for LCMS MS
• Mass Lynx version 4.1 for Micro Mass
• SAS version 9.2 Enterprise Guide 4.2
• SAS version 9.2 Enterprise Guide 4.2
• WinNonLin version 6.2 for PK analyses
• Electronic Document Management System
• SAP for Material Management

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CLINIC

• 180 beds clinic capacity
• 180 beds clinic capacity
• 29000 Healthy Volunteers Database
• In house volunteer screening facility
• In house clinical lab for safety assessments
• Fully equipped ICU to handle medical emergencies
• Synchronized clock systems (RF mesh network)

Pharmacy for controlled storage of Investigational Products

• Pharmacy for controlled storage of Investigational Products
• High volume centrifuges (temperature controlled)& freezers
• In-house catering facility to provide standardized food

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CLINICAL LAB

Dedicated automated biochemistry analyzers

• Dedicated automated biochemistry analyzers
• Back-up equipments to ensure continuity
• Testing for drugs of abuse

Accreditations

• ISO/IEC 15189 by NABL (National Accreditation Board for Testing &

Calibration Laboratories, India) Calibration Laboratories, India)

• College of American Pathologists (CAP)

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BIOANALYTICAL

• Pool of 24 Mass spectrometers for rapid turnaround
• Different varients of LC MS MS (API 2000/3200/4000 & Micromass)
• LC MS MS 8050/8060 (for molecules with low sensitivity)
• GC MS MS (single & triple quadrapole)
• ICP MS for elemental analysis
• ELISA analyses for Iron preparations
• Dedicated equipment & scientists for each project
• Dedicated QC team for data verification
• Power backup for all equipments

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SAMPLE STORAGE FACILITIES

• Cold storage, across 2 Sites in Hyderabad :

Cold storage, across 2 Sites in Hyderabad :

• Eleven Deep Freezers

– four (-) 200C – seven (-) 700C – (-) 200C walk-in-chamber

• Long term data archival facility
• Dedicated storage facilities for clinical samples,

bioanalytical samples, and clinical lab kits with central monitoring facility

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Thank You For Your Time Vimta - CR Division

www.vimta.com

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