site management organization (smo) establishment & management of a clinical evaluation

9th May 2011 of 30

1. COMPANY PROFILE

2. MISSION & VISION

3. INFRASTRUCTURE

4. OUR WEBSITE

5. TEAM PLAYERS

6. SERVICES PROVIDED

7. COMPANY REGISTRATION

8. INVESTIGATOR DATABASE

9. COLLABORATIONS & ACCREDITATION

10. STANDARD OPERATING PROCEDURES

11. PROJECT SUMMARY (SITE MANAGEMENT – FORMATMIN)

12. ROLES & RESPONSIBILITIES

13. PROJECT MANAGEMENT OVERVIEW

14. WORK PLAN

15. BUDGET

16. FUTURE PLANS

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Name: VASPAN Clinical Research Pvt. Ltd.

About us: VASPAN is a SMO, acts as a common platform

between Principal investigator and study sponsor/ CRO

for successful execution of clinical trials. It has been

established to meet the ever-growing performance and

quality expectations at the level of clinical trial sites.

Our SMO is an organization of excellence, which

provides a step ahead towards brighter future for the

upcoming clinical research trial in India. The main

headquarter of VASPAN organization is located in

Electronic city ,Bangalore.

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• Our company provides a wide range of

clinical trial and site management services

for the phase I to IV clinical trial as per

the regulatory requirements for achieving

the quality results.

• VASPAN is situated in a 25X25 sq feet

office in Lekshmi Towers, located in

Electronic city, Bangalore, Karnataka.

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Mission: Quality execution of clinical trials for

actualizing the ethical and scientific

excellence.

Vision: Creating a competitive advantage by

offering services through Innovation,

Customer Relations, and Delight our

sponsors by meeting their needs in fulfilling

the schedules with professional excellence in

all that we do.

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• WAREHOUSE

• TRAINING ROOM

• COUNSELLING ROOM

• CONFERENCE HALL

• PRODUCTION LABS

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Board of Directors

Dr. Amin Krupa Rajendrabhai

Dr. Adersh Nair

Dr. Preeti Bawa

Mr. Somnath Ghosh (Admin.)

Ms. Shaikh Nikhat (HR)

Mr. Vigneshwar Reddy (Project)

MD

CEO

COO

DIRECTOR

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Clinical Research Coordinators

Site Selection Specialists

Recruitment Specialists

Clinical Trial Assistant

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1. TRIAL MANAGEMENT

Study Design & Protocol Development

Selection & Training of potential investigators as per the guidelines

Pre – study site preparation

Site initiation & training

Site monitoring

Study closeout

2. DATA MANAGEMENT

Precise & Accurate data entry method, data storage & data archiving

Maintaining accuracy, integrity & confidentiality of study data at every stage of the clinical trial.

Supporting EDC

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3. REGULATORY SUPPORT

Facilitate ethics committee approval , DCGI clearance etc.

Site support for pre & post regulatory inspections

Obtain import and export licenses for new products

4. Site Coordinator Support

5. Corporate Training

6. Clinical Consulting

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Registrar of Companies

Obtain Director Identification Number (DIN) for

proposed directors (1098-FormDIN1) 1098-FormDIN1

Obtain Digital Signature Certificate (DSC) for proposed

directors (TCS) TCS

Reserving the company name (1030-Form1A) Form1A

Pay stamp duties, file all incorporation forms and

documents and obtain certificate of incorporation (COI)

Obtain a company seal

Apply for Permanent Account Number (PAN)

Obtain a tax Account Number (TAN)

Register under Shops and Establishment Act

Register for Value Added Tax (VAT)

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DIN.pdf

DIN.pdf

DIN.pdf

Digital Certificate Form.pdf

Name Availability.PDF

Certificate of Incorporation.JPG

• DIABETOLOGISTS

• ENDOCRINOLOGISTS

• ONCOLOGISTS

• CARDIOLOGISTS

• DERMATOLOGISTS

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HOSPITALS

• Cliniheart Multispeciality Hospital

• Fortis Hospitals

• Apollo Hospitals

• Wockhardt Hospitals

• Manipal Hospital

• M. S. Ramaiah Memorial Hospital

LABORATORY

Vantac Advance Molecular & Biochemical Labs.

ISO Certification

Our quality management system fully complies with the

requirements of ISO 9001:2008 standards.

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Our project undertaking and management as

well as record maintenance will be based on the

documentations mentioned below:

SOP OF SOPs

SOP of Organization

SOP of Principal Investigators

SOP of CRCs

SOP of Site Management

SOP of Archiving Study Documents

SOP for Auditing

Page 7 of 309th May 2011

Med plus Pharmaceuticals Ltd.(UK) intend to

conduct drug trial (phase III) in India for oral

hypoglycemic agent (Formatmin) to be marketed

both in India as well as in UK.

Formatmin is Biguanide oral hypoglycemic

agent. It is used in the treatment of Type –II

Diabetes Mellitus. It improves the glycemic control

by improving the insulin sensitivity and also by

decreasing the intestinal glucose absorption.

The results of pre-clinical as well as early clinical

(phase I & II) studies shows that Formatmin is safe

for using in human beings

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To meet the requirements, we propose to undertake

the following responsibilities:

Development of the regulatory requirements

for importing and storing the study drug to

India

Strategy development for selecting potential

investigators

Develop strategies for complete management

of the trial at the selected site including

regulatory requirements

Development of project’s budget plan

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Meeting the regulatory requirements

Preparation of Essential Documents

Identification of sites and other support services

IEC approval

Commercial and quality management

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NAME ROLE RESPONSIBILTIES

Dr. Preeti Bawa Project manager Accomplishing and obtaining the

objectives

Dr. Amin Krupa Rajendrabhai Deputy project Manager Assisting the project manager in

Accomplishing and obtaining the

objectives

Dr. Adersh Nair Data Manager Data collection and collating of data

and information.

Mr. Somnath Ghosh Task and Time Manager Skills and techniques use to manage

time when accomplishing specific task,

project and goals

Ms. Shaikh Nikhat Marketing manager Analyses the market and develops

marketing strategy.

Mr. Vigneshwar Reddy Financial Co-ordinator Overlooking the financial transactions.

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Aim:

To prove the efficacy and tolerability of oral

hypoglycemic drug Formatmin in large

population.

Objectives:

Primary objective: To assess the reduction of

blood glucose level in Type II Diabetes Mellitus

patients.

Secondary Objective: To prove patients

compliance to oral hypoglycemic (Formatmin

therapy)

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Study type: Interventional study.

Study Design: Randomized, double blinded,

multicentre, cross over study design.

Recruited patients will be randomly assigned into

two groups:

1) Control group: Standard drug (Sulfonylurea)

2) Active group: Patient receives Formatmin

850 mg twice a day.

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Study Population

960 Patients (Males & Females)

Site 1

Site 2

Site 3

Site 4

Site 5

Site 6

Study Group

Control Group

80

80

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A) Importer Exporter Code Number (IEC)

GUIDELINES FOR APPLICANTS

• Applying For New IEC Number

B) Application Form for Issue / Modification in

Importer Exporter Code Number (IEC)

C) Bank Certificate for Issue of IEC

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WORK PLAN_GANTT CHART.mpp

SMO Setup Budget

VASPAN Set Up Budget.xls

Project Budget

21-03-2011 rupees.xls

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VASPAN Set Up Budget.xls






• VASPAN is successful in obtaining

Clinical study (Phase III) from

MedPlus Pharmaceuticals Pvt. Ltd.

• Our company has a broad scope

that covers the conduct of clinical

trials on human subjects in India.

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• We would like to see our company at a

Global Platform undertaking major

Clinical Trials happening around the

Globe.

• We would also want to upgrade

VASPAN as a CRO in the near future.

• Enhancement of services and

commercialization.

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VASPAN Clinical Research Pvt. Ltd, represents

a management structure with the capability to

implement streamlined processes for its clinical

trials, ensuring quality, time efficiency and

transparency, from start till finish, across all

disciplines and functions involved.

VASPAN represents a ‘Best Practice’ example of

the combination of ‘Content’ and ‘Process’ in

raising standards internally within clinical

research sites.

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THANK YOU

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