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COMPANY PROFILE MISSION & VISION INFRASTRUCTURE OUR WEBSITE TEAM PLAYERS SERVICES PROVIDED COMPANY REGISTRATION INVESTIGATOR DATABASE COLLABORATIONS & ACCREDITATION STANDARD OPERATING PROCEDURES PROJECT SUMMARY (SITE MANAGEMENT FORMATMIN) ROLES & RESPONSIBILITIES PROJECT MANAGEMENT OVERVIEW WORK PLAN BUDGET 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
MD Dr. Amin Krupa Rajendrabhai CEO Dr. Adersh Nair

COO Dr. Preeti Bawa

DIRECTOR Mr. Somnath Ghosh (Admin.) Ms. Shaikh Nikhat (HR) Mr. Vigneshwar Reddy (Project)
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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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 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

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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 projects 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
Dr. Preeti Bawa Dr. Amin Krupa Rajendrabhai

ROLE
Project manager Deputy project Manager

RESPONSIBILTIES
Accomplishing and obtaining the objectives Assisting the project manager in Accomplishing and obtaining the objectives Data collection and collating of data and information. Skills and techniques use to manage time when accomplishing specific task, project and goals Analyses the market and develops marketing strategy. Overlooking the financial transactions.

Dr. Adersh Nair Mr. Somnath Ghosh

Data Manager Task and Time Manager

Ms. Shaikh Nikhat Mr. Vigneshwar Reddy

Marketing manager Financial Co-ordinator

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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

Study Group
80 80

Site 4
Site 5 Site 6
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Control Group

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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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SMO Setup Budget VASPAN Set Up Budget.xls Project Budget 21-03-2011 rupees.xls

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 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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