Sovereign Health Brochure
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Sovereign Health Brochure

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    Sovereign Health Brochure Sovereign Health Brochure Document Transcript

    • 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 ? 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
    • 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.
    • 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.
    • 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 ? 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