Clinical Research Capabilities Bioavailability & Bioequivalence Studies Clinical Research Division
CLINICAL RESEARCH SERVICES 03
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 04
Bioavailability & Bioequivalence Studies 05
REGULATORY AUDIT EXPERIENCE REGULATOR NO. OF INSPECTIONS DCGI (India) DCGI (India) 4 4 FDA (USA) 10 MHRA (UK) 2 BfArM (Germany) 2 ASNM (France) 2 WHO 4 DRAs of Denmark, Portugal & DRAs of Denmark, Portugal & 1 1 Sweden* MCC (South Africa) 2 ANVISA (Brazil) 2 NPCB (Malaysia) 1 06
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) 07
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 08
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 No. of pivotal studies conducted since conducted so far DCGI (India) 1994 >400 USFDA USFDA 2000 2000 >300 >300 EU 2001 >50 WHO 2000 >15 Others (Health Canada, 2000 >50 TGA, MCC, etc.) 09
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 10
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 11
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) 12
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 13
SAMPLE STORAGE FACILITIES • Cold storage, across 2 Sites in Hyderabad : Cold storage, across 2 Sites in Hyderabad : • Eleven Deep Freezers – four (-) 20 0 C – seven (-) 70 0 C – (-) 20 0 C walk-in-chamber • Long term data archival facility • Dedicated storage facilities for clinical samples, bioanalytical samples, and clinical lab kits with central monitoring facility 14
Thank You For Your Time Vimta - CR Division www.vimta.com 15
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