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Clinical Research Services
VLL/CR/G20/ 2009/09/30
 Clinical Research Services
 About VIMTA Labs
 Why VIMTA?
Services
 Bioavailability/Bioequivalence studies
 Clinical end point studies
 Phase I-IV trials of drugs and medical devices
 Bioanalytical Services
 Safety and efficacy studies on cosmetics
Full Service CRO for BA/ BE Studies
 Regulatory services
 Medical Writing
 ICF Design & implementation in regional
languages.
 IEC (IRB) Approval
 Volunteer recruitment & Clinical screening
 Clinical conduct
 PK Analysis
 Stats & Report Writing
 Adverse Event Reporting
 Long term archival
Clinical Study Experience
 Bioavailability/Bioequivalence studies on various dosage
forms: Tablets, capsules, film strips, gels, jellies, oral solutions,
dermal patches
under several study designs
 Single dose, cross over studies
 Single dose, replicate design studies
 Multiple dose, steady state design studies
 Parallel design studies
 Clinical end point studies: Gastrointestinal
 Safety and efficacy studies on cosmetics: Deodarants,
Industrial Hand Wash products, Shampoos, etc.
Total No. of clinical studies completed so far: 1000+
BA / BE Studies
 Bio-availability/Bio-equivalence studies conducted since
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1994
Volunteer database of 20,000 healthy volunteers,
including female volunteers
200 bed clinic capacity
Fully equipped ICU (8 beds)
Bioanalytical lab, with 11 mass specs, dedicated to BE
studies - operates round the clock
In-house Clinical Lab, that is among the most
sophisticated in India
Notable Achievements
 FDA Submissions: Provided bioanalytical support for
more than 100 ANDA filings, few INDs and NDAs
 FTE model: Provided bioanalytical services to a large
American pharma company under FTE model, that
resulted in a rate as low as $19 per sample
 Developed capabilities in a diverse set of analytical
methodologies for PK analysis – such as LC MS, GC
MS, ICP MS, RIA, etc.
Capabilities for Studies in
Patient Population
 Site Management and Study Monitoring services for
Phase II-IV trials
 PK studies in patients
 Clinical end point studies
Site Management Services
 Investigator (& site personnel) support
 Site Support Study Conduct
 Facilitate Initiation, Monitoring, Close-out,
 Close coordination with Sponsors and CROs &
 Site preparation for Audit
 Study Process Management
Vimta Site Management
Services: for Investigators
 On-site training programs to PI and study team
 Trained and experienced clinical research coordinators
placed on site
 Protocol analysis
 Budget negotiations with Sponsor
 Implementing proven patient recruitment strategies
 Independent protocol audits by QA team
 Preparation for external Audit (sponsor/FDA/Third party)
Vimta Site Management Services:
for Clinical sites (Hospitals)
 Site set up & Conduct of Clinical Trials
 IRB/ EC set up & members’ training
 Site specific & EC WPDs & SOP’s
 GCP and protocol training (to Site Staff)
 Onsite Pharmacy set up
 Trained and experienced clinical research coordinators
placed on site
 Drug Safety Services
 Training
Vimta Site Management Services:
for Study Processes
 Patient- Recruitment, Informed Consent, Investigations, admissions (if inpatient),
follow-ups (if outpatient), compensation, information & queries;
 Study Drugs or Devices management including Randomization & IVRS, cold/
temperature controlled storage, drug/ device dispensation logs & accountability;
 Documents management including but not limited to
Informed Consent Documents & their translations / back translations; CRF entries
& Query generation; Diary card preparation & its training; Site master files; Study
logs; Clinical trial reports;
 Regulatory including a] Ethics committee correspondence, approvals and query
management, b] DSMB coordination
Collaborations
 Vimta is now associated with multiple
Indian hospital sites. Overall 20 sites
to collaborate.
 7 Sites signed MOUs for CCEs
exclusively with Vimta.
New Delhi
Lucknow
West Bengal
Vishakapatnam
Mumbai
 Spread across TAs-2 teaching
hospitals/medical universities; TA
Specific- 1 Neuropsychiatry, 1 Derma
& 1 oncology.
Rajamhundry
Hyderabad
Bangalore
Coimbatore
Chennai
Madurai
 Sites chosen based on clinical care &
clinical research capabilities.
 Predominantly near South India:
better logistics& cost control.
Study Monitoring Services
 Clinical Trial Operations
 Medical Affairs
 Clinical Quality Control (& Independent Quality Assurance)
 Project Management
 Regulatory Liaison & Consulting
 Clinical Data Management & Biometrics
Study Monitoring Services:
Clinical Operations
 Education profile: M.D, M.B.B.S, Ph.D, M. Pharmacy;
 Team Composition: Project Managers, Group Leaders, Scientists, CRAs, CTAs
 Experience profile:
 PM ~ 5-7 years: M.Pharm, Ph.D
 GL & Above~ 1-4 years: M.B.B.S, M.D, Ph.D
 Scientists & CRA ~ 1-2 years: M.Pharm, M.Sc
 Main Functions:
 Site Initiation, Monitoring, Close-out, Project Management - Experienced CRAs
& PMs
 Coordinating Site Audits- With External Auditors
 Medical Monitoring-Qualified & Trained (CR) Clinicians/ Consultants available
Site Monitoring Services:
Medical Affairs
 Education profile: M.D, M.B.B.S, M.Pharm, M.Sc
 Team Composition:
 Medical Monitors & Reviewers- M.D / M.B.B.S with Experience
 Safety Associates: M.B.B.S / M.Pharm / M.Sc with Experience;
 Clinical Associates- M.B.B.S / M.Pharm / M.Sc with Experience
 Medical Writers- M.D/M.B.B.S / M.Pharm with Experience
 Functions:
 Investigator/ Site Pre-Qualification, Selection & Feasibility – Feasibilities<1-2
Wks;
 Trial Documents’ Preparation- Protocols & Reports;
 Support to Clinical Operations for Medical Monitoring & Drug Safety;
Notable Achievements
 FDA Submissions: Provided bioanalytical support for
more than 100 ANDA filings, few INDs and NDAs
 FTE model: Provided bioanalytical services to a large
American pharma company under FTE model, that
resulted in a rate as low as $19 per sample
 Developed capabilities in a diverse set of analytical
methodologies for PK analysis – such as LC MS, GC
MS, ICP MS, RIA, etc.
Summary of Regulatory
Submissions
Studies
conducted
since
year of 1st
inspection
No. of pivotal
studies
conducted so
far
US-FDA
BE studies, TK
studies,
Phase-I trials
2002
2005
> 200
WHO
BE studies
2000
2004
> 15
EU
BE studies
2001
2005
> 20
DCGI (India)
BE studies
1994
N/A
>300
Others
(Health
Canada, TGA,
MCC, etc.)
BE studies
2000
N/A
>20
Regulatory
Agency
Study reports
submitted
 Clinical Research Services
 About VIMTA Labs
 Why VIMTA?
Service Offerings
Bio-analytical
Clinical Research
Clinical Ref. Lab
Adv. Mol. Bio.
VIMTA
Pre-Clinical
Analytical
R&D
Environmental
Recognitions & Accreditations
 Accreditations
• ISO 15189 and ISO 17025 by National Accreditation Board for
Testing & Calibration Laboratories (NABL), India
 Regulatory Audit History
• US FDA (Ref. ICH GCP and GLP) – 4 inspections
• DRAs of Sweden, Denmark, & Portugal (Ref. ICH GCP and
GLP)
• BfArM Germany (Ref. ICH GLP)
• WHO (Ref. ICH GCP and GLP) – 4 inspections
• Anvisa, Brazil (certification due for renewal)
• Pre-qualified by WHO for cGMP compliance
IT Infrastructure
 Hardware:
 IBM i550 server (Consists 12 Logical Servers)
 IBM DS 6800 (Capacity 15 TB expandable to 62 TB)
 First 10 G Passive Network in the Asia Pacific Region
 Cisco 6513 Integrated Services Router
 Software:
 Labware LIMS
 Waters SDMS (Scientific Data Management System)
 SAS and WinNonLin
 Lotus DomDoc (for Document Management)
Staff
• Scientific staff - 442
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Undergraduates – 125
Masters – 274
Doctorates (Ph.D.) – 22
Clinicians (MBBS/MDs) – 21
• Supporting staff – 265
• Total – 707
 Clinical Research Services
 About VIMTA Labs
 Why VIMTA?
Why VIMTA?
 Independence: Truly independent CRO, not affiliated to any
pharmaceutical or other drug development company, or any other
organization
 Good Governance: Being first CRO to be listed national stock
exchanges of India, we operate in an ethical and transparent manner
 Financial stability:
 25 years of track record in sustained growth
 Strong balance sheet
 Ability to fund massive investments: invested ~$30 M during the last
three years in capacity building
 Credibility & Strong Project Management Skills: Long term
partnerships built with many industry leaders across the globe
Thank you