1. Local Solutions to global challenges
Sovereign Health is a Clinical Trial Management
Our mission is to Conduct Organization, managing clinical trials across the
Studies that conform to the globe with compliance to ICH-GCP providing clinical
trial support to Pharmaceutical and Biotechnology
highest level of quality, companies and Clinical Research Organizations
compliance, ethical standards (CROs) worldwide.
and patient care. Sovereign Health was established in 2006 to
improve the capability of the site level service required
for running high quality ICH-GCP clinical trials. This
Why Sovereign Health was a response to the demands of global
Dedicated clinical research sites under one
? pharmaceutical companies for conducting
management multinational trials that include India. Sovereign owns
? of sites trained to international standards
Network and operates its own dedicated clinical research
? therapeutic experience
In-depth, sites, as well as provides sites and investigators
Innovative leadership
?
assistance in conducting clinical studies conforming
Comprehensive training & development
?
to ICH GCP guidelines to ensure accuracy,
Local leadership of key opinion leaders
?
authenticity and consistency of quality of clinical data
Centralized systems and infrastructure
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generated.
Centralized training and project management,
?
Standardized SOPs and QA processes
? Our sites are in locations covering a wide and
Extensive experience in CNS studies
? heterogeneous mix of population. This is the first
Comprehensive training in standard operating
? network of its kind in India to help provide the fastest
procedures
patient recruitment and specialty areas for clinical
High recruitment and retention
?
research in Phase II to phase IV studies. We are
Large database of patients
?
fortunate to have with us Principal Investigators who
GCP Compliance
?
represent some of India's best clinicians and
Knowledge of local and global regulations
?
researchers and are key opinion leaders in their fields
? in local regulatory standards
Expertise
Capabilities in Regulatory Affairs
?
of expertise.
Capabilities in Project Management
?
Sovereign Health's specialist focus in central
Data quality of international standards
?
management policy means all sites benefit from
Centralized infrastructure with data generation
?
capabilities of international standards the same high standards of infrastructure and
Fully bilingual staff
? quality control systems as well as regular
Local expertise
? centralized training for site staff and
? Offices
4 global investigators.
Integrating with your organisation for better results

2. Project Management
At Sovereign a High Calibre Clinical Research Team
well known for pro activeness, professionalism and
quality in the field works in partnership with clients to
ensure that the project is effectively and efficiently
managed.
Every project is assigned to a Project Manager who
is experienced in all aspects of handling a successful
clinical project in accordance to ICH/GCP, local
regulations and SOPs. We utilize a team-oriented
approach, leveraging the years of experience that
each member has, along every step of the process,
thereby providing the client with a high quality
service, at the same time ensuring that all timelines
are strictly adhered to.
Providing innovative leadership the project managers
serve as a primary resource and a single point of
communication for the different projects. Through
meticulous planning and co-ordination, the team strives
to deliver projects with a clear focus on providing quality
backed by on-time and on-cost deliverables.
The team provides dedicated and well equipped
clinical research sites spread all across India for
carrying out Sponsor clinical trial and trains, certify
and position clinical research coordinators at the
sites to assist the investigator in conduct study as per
protocol.
Site Management
Sovereign Health upholds stringent standards to ensure adequate protection of the rights and safety of all
subjects involved in clinical investigations. We offer complete Site Management Services across the country,
delivered through a highly experienced team. To support the work of principal investigators and sub-
investigators trained and qualified coordinators are positioned at the site.
Investigator Services
We identify appropriate investigators and continually nurture relationships throughout the study to ensure the
timely, cost-effective success of clinical trial. From recruitment, to essential documents, to agreements and
budgets to investigator meetings, to grants management, the Investigator Services staff assigned to the project
Your partner in making studies successful.

3. provides comprehensive services. The
What makes Sovereign Health Different?
clear, continual communication with a single
Extensive Database of Investigators and study staff
? point-of-contact is the key to our strong
? Centralized Services
Providing relationships with investigators. Our
? Monitoring
Internal extensive database of experienced
Client satisfaction
? investigators provides access for a quick
Customer Support
?
study initiation within stipulated timeframe.
Regulatory Consultancy
The Regulatory Affairs Department at Sovereign is geared to provide the most effective regulatory assessment
and strategy for timely submission and early approval. Our pharmaceutical regulatory consultant services offer
the best solutions to meet all kinds of challenges for pharmaceutical, biotechnology, diagnostics and CRO
industries.
Sovereign provides regulatory consulting as a customized stand-alone service or through our full service
clinical trials. Our regulatory professionals ensure client satisfaction through streamlined procedures that
provide rapid turnaround of tasks, enabling faster start up and compliance with applicable guidelines.
Quality Assurance Services
Sovereign's quality assurance and quality control systems aim to
ensure high quality performance throughout the entire study period.
The Quality Assurance department follows an independent,
planned, systemic, ongoing quality assessment program focusing
on management and organizational performance to ensure
excellence in delivery to our sponsors. Self-check systems are in
As part of the
place to provide improvement and control of quality in management Cognition Group,
of clinical studies.
Sovereign Health has
Quality Assurance has established systems and processes to
ensure that clinical work is performed and data are produced in
inherited the expertise
compliance with all applicable regulations, guidelines, sponsor and of conducting CNS
clients' SOPs, Client contracts. Our experienced quality assurance
professionals work with our clients to conduct internal and external clinical trials in over
GCP auditing. All studies performed are audited by our Quality 40 countries
Assurance and Compliance Department according to FDA
regulations and ICH-GCP guidelines. Audits are conducted
according to Sponsor/ CRO SOPs, and client contracts. SOPs are
rigorously followed and in-service training is attended by all the site
personnel on a regular basis to guarantee the highest quality and
compliance with ICH-GCP guidelines
Dedicated and competent Project Management Team.

4. Co-ordination of Study kick-off and Investigator Meetings
An Investigator meeting coordinated by Sovereign is geared towards
creating a dynamic environment for the interaction of individuals with a
common purpose. These interactive meetings are designed to be both
informative and thought provoking and enable investigators to develop a
dialogue with sponsors on best practices for gathering clinical trial data.
Additional The meetings also include training in key areas including trial protocol,
Services current Good Clinical Practice and study-specific procedures. From
scientific presentations to program management, meeting services,
Pharmacovigilance and Safety
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creative design and production, Sovereign aims to conduct meetings
Monitoring that are engaging, dynamic and effective
? Trial Supply
Clinical Training
Management
Centralized and continuous training are key features at Sovereign
Document Reviews and
? Health sites. Every member is given a comprehensive induction. Their
Translations of Study individual training needs are assessed and training is provided on
Documents
continuous basis. Our team has the expertise to conduct ICH GCP
? and Research Writing
Medical training and workshops for clinical research professionals. Prior to
Study Monitoring
?
initiating trials, we ensure that all investigators and site personnel are
well trained in GCP and any training that is protocol specific.
? and Local Laboratory
Central
Services Data Management
Drug Importation and
? Sovereign offers cost-effective Data Management solutions customized
Accountability to meet the requirements of clients. The Project Management teams
work closely with the clients and act as the custodians of timelines and
Investigational Product
?
Management using a state-of- responsibilities through all phases of the project
the-art Central Pharmacy
The Group provides secure electronic data capture (EDC) and near real
? Services
Courier
time web reporting as well as data management, statistical analysis
services. The unique web-based reporting system allows access to data
in near real time. The data is available to viewing immediately after it is
uploaded into a customized database. Interim data reports are provided
and data queries are raised throughout the trial. The data management
team utilizes the software Microsoft SQL Server 2000/2005, Extensible
Markup Language, Active Server Pages, SAS/SPSS.
Sovereign Health India Pvt. Ltd.
India Office : SCO - 28, IIIrd Floor, Sector - 14, Gurgaon - 122 001 (Haryana)
Tel: 91 124 4166 400 Fax: 91 124 4166 449
US Office : 254 Chapman Road, Topkis Building, Suite 100, Newark, DE 19702
Tel: +1-302-454-1265 Fax: +1-302-454-7868
UK Office : Twisleton Court, Priory Hill Dartford, Kent Da1 2EN
Tel: +44-1322-286 862 Fax: +44-1322-319271
www.sovhealthindia.com