sovereign health profile

III Floor, SCO-28, Sector-14, Gurgaon (Haryana)

Tel: +91-124-4166412Fax: +91-124-4166449

http://www.sovhealthindia.com

Sovereign Health India Pvt. Ltd.

Introduction

� Warm Greetings from Sovereign Health India

Pvt. Ltd!!

� Sovereign Health is a Clinical Trial Management Organization, managing clinical trials in all therapeutic areas across the globe with compliance to ICH-GCP providing complete range of clinical research services to Pharmaceutical, Medical Device,

and Biotechnology companies

Sovereign Health – India

Mission:� To conduct studies that conform to the highest level

of quality, compliance, ethical standards and patient care to generate valid, reliable, credible and quality research data.

ICH-GCP compliant trials

� In-depth knowledge of national & international regulatory issues

� Local expertise

� Staff training

� Centralized systems and infrastructure

� Standardized SOPs and QA processes

Quality

� Sites are judged on the following:� Number of patients recruited

� Number of DCFs generated

� Adherence to regulatory and protocol compliance

� Standard SOPs

� Certified GCP and study specific training

� Membership of professional bodies

SovHealth Experiencein the conduct of CNS studies

4009Total

Pipeline0501Down Syndrome

Completed 05

Completed0302Schizophrenia

Enrollment starts Nov 08 0301MDD

Completed04

Ongoing, completion Q4-08 07

Completed02

03

Parkinson’s Disease

Enrollment starts Dec 0809

Ongoing, completion Q1-090202Alzheimer Disease

StatusNo. of Sites

No.ofStudies

Indication

Experience in the conduct of Non CNS studies

Feasibility stage1001Gynecology

Q1-090501Gastroenterology

2 studies-Q4-08,

1 study-Q1-09 & 1 study-pipeline

2004Oncology

1 study-Q1-09, 1 pipeline1102Diabetes

Feasibility stage0501Allergic Rhinitis

Q1-090201Medical device

Q1-090601Total Hip Replacement

Pipe Line0301Paediatric Psoriasis

Enrollment-Dec’08,

2 study-Pipeline

1003Hepatitis

Enrollment Nov’080401Rheumatoid Arthritis

Pipeline0601Osteo Arthritis

Our Investigator Pool

Sovereign Health has an extensive database of over 600 highly experienced Investigators from the following therapeutic areas:

� Cardiology (50)� Critical care (18)� Dental (35)� Dermatology (30)� Diabetology (45)� Endocrinology (45)� Gastroenterology (28)� Gynecology (30)� Internal Medicine (30)

� Nephrology (26)� Neurology (45)� Orthopaedics (70)� Ophthalmology (30)� Oncology (170)� Psychiatry (50)� Urology (15)

Investigator Coverage Across India

� North & Central Zone – 250

� West Zone – 150

� South Zone – 150

� East Zone – 50

Most of these investigators hail from Premiere Institutes

of India with a vast patient pool readily available to

participate in clinical studies.

Services Offered

� Project Management

� Clinical Operations

� Investigator Services

� Regulatory consultancy

� Clinical Trial Supply Management

� Quality Assurance Services

� Medical & research writing

Other Services

� Training programs and presentations

� Corporate compliance program development and maintenance

� FDA/RA inspection preparation

� Mock FDA/RA inspections

� Facilitation of FDA/RA inspections

What makes us different?

� Extensive Database of Investigators and study staff

� Providing Centralized Services

� Internal Monitoring

� Client satisfaction

� Regulatory Services

� Customer Support


� Extensive Database of Investigators and study staff

� Sovereign Health has an extensive database of highly qualified and experienced Investigators and extensively trained and experienced CRCs to support the Investigators throughout the study.

� We maintain a healthy and strong association and share an excellent rapport with the Investigators and the study staff at all the site. This helps us conducting feasibilities for studies in various therapeutic areas within a short timeline. We have an experience of conducting feasibility at 10 sites within a short span of 1 working day.


� Providing Centralized Services

� Sovereign Health has dedicated site based personnel, reporting to Sovereign Health’s Central office with daily recruitment data, documents data and handling of logistics at sites. It is often seen that Investigators have competing priorities and they cannot prioritize on a Sponsor study, thus our dedicated site based personnel ensures Sponsor outcomes are met within

timelines.

What Makes us different?

� We ensure that all our site based personnel are well versed withthe SOPs and ICH GCP and other regulatory guidelines before being placed at the respective sites. We recruit local personnelas CRCs who have a command with the local dialect to minimize the difficulty of communication with the patient population.

� Sovereign Health provides online training and certification to the Investigators not only towards the ongoing studies but also in general to the various other clients and students.


� Our CRCs are highly efficient to manage huge patient population in hospitals having huge OPD crowd. They are also trained to manage patients with the utmost hospitality and care in situations of long OPD hours and / or circumstances such as longer hours of procedure during screening and also sometimes during the study.


� Internal Monitoring

� The fact that we conduct internal monitoring visits at our sitesprior to the RMV (Regular Monitoring Visit) done by Sponsor / CRO representatives, makes SH a unique SMO.

� Our monitors (Project Associates) visit every site as and when required to monitor the TMF (study file) to check the availability of all the documents as per the Regular Monitoring Visit checklist and also ensure that all the previous issues with DataClarification Forms have been resolved. This activity of our SMOsaves time and effort of the Sponsor / CRO personnel and also helps the study conduct with minimum DCFs being generated.



� Sovereign Health maintains a very healthy relation with the clients (Sponsors and CROs) by delivering a timely and quality data from the sites. This is how we are favored by our clients and being awarded with repeated number of studies.

� Our Investigators are well recognized in the Clinical Research and pharmaceutical Industry and have also been awarded for their valuable contribution towards the drug development process.



� This is the reason behind the massive expansion of SovHealth’stherapeutic area of expertise from CNS to a domain of varied therapeutic areas such as Gynecology, Urology, Hepatoogy, Gastroenterology, Oncology, Dermatology, Orthopedics etc within a short span time.


� Regulatory Services

� SHIPL also renders the services of regulatory submission and timely approval to the Sponsor with minimal hassle.

� Customer Support

� We offer 24 X 7 round the clock support service to all our sitesand clients.

Success of Clinical Trials depends on

Good information flowGood information flow

Open communicationOpen communication

Channels among participantsChannels among participants

Contact Us

� For all business related queries please contact

Mr. Suraj Shaw

(Business Development Executive-Clinical Research)

at

[email protected] or +91-9311423408

A partner in your study success

Thanks !

www.sovhealthindia.com

Sovereign Health

sovereign health profile

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