sovereign health brochure
TRANSCRIPT
Integrating with your organisation for better results
Our mission is to Conduct Studies that conform to the highest level of quality, compliance, ethical standards and patient care.
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
Why Sovereign Health
?Dedicated clinical research sites under one management
?Network of sites trained to international standards
?In-depth, therapeutic experience
?Innovative leadership
?Comprehensive training & development
?Local leadership of key opinion leaders
?Centralized systems and infrastructure
?Centralized training and project management,
?Standardized SOPs and QA processes
?Extensive experience in CNS studies
?Comprehensive training in standard operating procedures
?High recruitment and retention
?Large database of patients
?GCP Compliance
?Knowledge of local and global regulations
?Expertise in local regulatory standards
?Capabilities in Regulatory Affairs
?Capabilities in Project Management
?Data quality of international standards
?Centralized infrastructure with data generation capabilities of international standards
?Fully bilingual staff
?Local expertise
?4 global Offices
Sovereign Health is a Clinical Trial Management
Organization, managing clinical trials across the
globe with compliance to ICH-GCP providing clinical
trial support to Pharmaceutical and Biotechnology
companies and Clinical Research Organizations
(CROs) worldwide.
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
was a response to the demands of global
pharmaceutical companies for conducting
multinational trials that include India. Sovereign owns
and operates its own dedicated clinical research
sites, as well as provides sites and investigators
assistance in conducting clinical studies conforming
to ICH GCP guidelines to ensure accuracy,
authenticity and consistency of quality of clinical data
generated.
Our sites are in locations covering a wide and
heterogeneous mix of population. This is the first
network of its kind in India to help provide the fastest
patient recruitment and specialty areas for clinical
research in Phase II to phase IV studies. We are
fortunate to have with us Principal Investigators who
represent some of India's best clinicians and
researchers and are key opinion leaders in their fields
of expertise.
Sovereign Health's specialist focus in central
management policy means all sites benefit from
the same high standards of infrastructure and
quality control systems as well as regular
centralized training for site staff and
investigators.
AdditionalServices
?Pharmacovigilance and Safety Monitoring
?Clinical Trial Supply Management
?Document Reviews and Translations of Study Documents
?Medical and Research Writing
?Study Monitoring
?Central and Local Laboratory Services
?Drug Importation and Accountability
?Investigational Product Management using a state-of-the-art Central Pharmacy
?Courier Services
Co-ordination of Study kick-off and Investigator Meetings
Training
Data Management
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.
The meetings also include training in key areas including trial protocol,
current Good Clinical Practice and study-specific procedures. From
scientific presentations to program management, meeting services,
creative design and production, Sovereign aims to conduct meetings
that are engaging, dynamic and effective
Centralized and continuous training are key features at Sovereign
Health sites. Every member is given a comprehensive induction. Their
individual training needs are assessed and training is provided on
continuous basis. Our team has the expertise to conduct ICH GCP
training and workshops for clinical research professionals. Prior to
initiating trials, we ensure that all investigators and site personnel are
well trained in GCP and any training that is protocol specific.
Sovereign offers cost-effective Data Management solutions customized
to meet the requirements of clients. The Project Management teams
work closely with the clients and act as the custodians of timelines and
responsibilities through all phases of the project
The Group provides secure electronic data capture (EDC) and near real
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.
Local Solutions to global challenges
Project Management
Site Management
Investigator Services
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.
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.
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
provides comprehensive services. The
clear, continual communication with a single
point-of-contact is the key to our strong
relationships with investigators. Our
extensive database of experienced
investigators provides access for a quick
study initiation within stipulated timeframe.
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.
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
place to provide improvement and control of quality in management
of clinical studies.
Quality Assurance has established systems and processes to
ensure that clinical work is performed and data are produced in
compliance with all applicable regulations, guidelines, sponsor and
clients' SOPs, Client contracts. Our experienced quality assurance
professionals work with our clients to conduct internal and external
GCP auditing. All studies performed are audited by our Quality
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
Regulatory Consultancy
Quality Assurance Services
Dedicated and competent Project Management Team.Your partner in making studies successful.
What makes Sovereign Health Different?
?Extensive Database of Investigators and study staff
?Providing Centralized Services
?Internal Monitoring
?Client satisfaction
?Customer Support
As part of the Cognition Group,
Sovereign Health has inherited the expertise
of conducting CNS clinical trials in over
40 countries
Project Management
Site Management
Investigator Services
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.
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.
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
provides comprehensive services. The
clear, continual communication with a single
point-of-contact is the key to our strong
relationships with investigators. Our
extensive database of experienced
investigators provides access for a quick
study initiation within stipulated timeframe.
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.
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
place to provide improvement and control of quality in management
of clinical studies.
Quality Assurance has established systems and processes to
ensure that clinical work is performed and data are produced in
compliance with all applicable regulations, guidelines, sponsor and
clients' SOPs, Client contracts. Our experienced quality assurance
professionals work with our clients to conduct internal and external
GCP auditing. All studies performed are audited by our Quality
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
Regulatory Consultancy
Quality Assurance Services
Dedicated and competent Project Management Team.Your partner in making studies successful.
What makes Sovereign Health Different?
?Extensive Database of Investigators and study staff
?Providing Centralized Services
?Internal Monitoring
?Client satisfaction
?Customer Support
As part of the Cognition Group,
Sovereign Health has inherited the expertise
of conducting CNS clinical trials in over
40 countries
Integrating with your organisation for better results
Our mission is to Conduct Studies that conform to the highest level of quality, compliance, ethical standards and patient care.
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
Why Sovereign Health
?Dedicated clinical research sites under one management
?Network of sites trained to international standards
?In-depth, therapeutic experience
?Innovative leadership
?Comprehensive training & development
?Local leadership of key opinion leaders
?Centralized systems and infrastructure
?Centralized training and project management,
?Standardized SOPs and QA processes
?Extensive experience in CNS studies
?Comprehensive training in standard operating procedures
?High recruitment and retention
?Large database of patients
?GCP Compliance
?Knowledge of local and global regulations
?Expertise in local regulatory standards
?Capabilities in Regulatory Affairs
?Capabilities in Project Management
?Data quality of international standards
?Centralized infrastructure with data generation capabilities of international standards
?Fully bilingual staff
?Local expertise
?4 global Offices
Sovereign Health is a Clinical Trial Management
Organization, managing clinical trials across the
globe with compliance to ICH-GCP providing clinical
trial support to Pharmaceutical and Biotechnology
companies and Clinical Research Organizations
(CROs) worldwide.
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
was a response to the demands of global
pharmaceutical companies for conducting
multinational trials that include India. Sovereign owns
and operates its own dedicated clinical research
sites, as well as provides sites and investigators
assistance in conducting clinical studies conforming
to ICH GCP guidelines to ensure accuracy,
authenticity and consistency of quality of clinical data
generated.
Our sites are in locations covering a wide and
heterogeneous mix of population. This is the first
network of its kind in India to help provide the fastest
patient recruitment and specialty areas for clinical
research in Phase II to phase IV studies. We are
fortunate to have with us Principal Investigators who
represent some of India's best clinicians and
researchers and are key opinion leaders in their fields
of expertise.
Sovereign Health's specialist focus in central
management policy means all sites benefit from
the same high standards of infrastructure and
quality control systems as well as regular
centralized training for site staff and
investigators.
AdditionalServices
?Pharmacovigilance and Safety Monitoring
?Clinical Trial Supply Management
?Document Reviews and Translations of Study Documents
?Medical and Research Writing
?Study Monitoring
?Central and Local Laboratory Services
?Drug Importation and Accountability
?Investigational Product Management using a state-of-the-art Central Pharmacy
?Courier Services
Co-ordination of Study kick-off and Investigator Meetings
Training
Data Management
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.
The meetings also include training in key areas including trial protocol,
current Good Clinical Practice and study-specific procedures. From
scientific presentations to program management, meeting services,
creative design and production, Sovereign aims to conduct meetings
that are engaging, dynamic and effective
Centralized and continuous training are key features at Sovereign
Health sites. Every member is given a comprehensive induction. Their
individual training needs are assessed and training is provided on
continuous basis. Our team has the expertise to conduct ICH GCP
training and workshops for clinical research professionals. Prior to
initiating trials, we ensure that all investigators and site personnel are
well trained in GCP and any training that is protocol specific.
Sovereign offers cost-effective Data Management solutions customized
to meet the requirements of clients. The Project Management teams
work closely with the clients and act as the custodians of timelines and
responsibilities through all phases of the project
The Group provides secure electronic data capture (EDC) and near real
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.
Local Solutions to global challenges