Clinical Research Services

VLL/CR/G20/ 2009/09/30

Clinical Research Services

About VIMTA Labs

Why VIMTA?

ServicesBioavailability/Bioequivalence studiesClinical end point studiesPhase I-IV trials of drugs and medical devicesBioanalytical ServicesSafety and efficacy studies on cosmetics

Full Service CRO for BA/ BE StudiesRegulatory servicesMedical Writing ICF Design & implementation in regional

languages. IEC (IRB) ApprovalVolunteer recruitment & Clinical screeningClinical conductPK AnalysisStats & Report WritingAdverse Event ReportingLong term archival

Clinical Study ExperienceBioavailability/Bioequivalence studies on various dosage forms:

Tablets, capsules, film strips, gels, jellies, oral solutions, dermal patchesunder 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 StudiesBio-availability/Bio-equivalence studies conducted since 1994Volunteer database of 20,000 healthy volunteers, including

female volunteers200 bed clinic capacityFully equipped ICU (8 beds)Bioanalytical lab, with 11 mass specs, dedicated to BE studies

- operates round the clockIn-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 ServicesInvestigator (& 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 ManagementServices: 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.

Spread across TAs-2 teaching hospitals/medical universities; TA Specific- 1 Neuropsychiatry, 1 Derma & 1 oncology.

Sites chosen based on clinical care & clinical research capabilities.

Predominantly near South India: better logistics& cost control.

Hyderabad

New Delhi

Chennai

Vishakapatnam

Rajamhundry

Coimbatore

Madurai

Mumbai

LucknowWest Bengal

Bangalore

Clinical Trial Operations

Medical Affairs

Clinical Quality Control (& Independent Quality Assurance)

Project Management

Regulatory Liaison & Consulting

Clinical Data Management & Biometrics

Study Monitoring Services

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

Study Monitoring Services: Clinical Operations

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

Regulatory Agency

Study reports submitted

Studies conducted

sinceyear of 1st inspection

No. of pivotal studies

conducted so far

US-FDABE 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

Clinical Research Services

About VIMTA Labs

Why VIMTA?

Service Offerings

Bio-analytical

Analytical

Pre-Clinical

Clinical Ref. LabClinical Research

Environmental

Adv. Mol. Bio.

R & D

VIMTA

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 InfrastructureHardware:

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• 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