Sovereign Health  Profile
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Sovereign Health  Profile Sovereign Health Profile Presentation Transcript

  • Sovereign Health India Pvt. Ltd. III Floor, SCO-28, Sector-14, Gurgaon (Haryana) Tel: +91-124-4166412 Fax: +91-124-4166449 http://www.sovhealthindia.com
  • 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 Experience in the conduct of CNS studies Indication No.of No. of Status Studies Sites Alzheimer Disease 02 02 Ongoing, completion Q1-09 09 Enrollment starts Dec 08 Parkinson’s Disease 02 Completed 03 07 Ongoing, completion Q4-08 04 Completed MDD 01 03 Enrollment starts Nov 08 Schizophrenia 02 03 Completed 05 Completed Down Syndrome 01 05 Pipeline Total 09 40
  • Experience in the conduct of Non CNS studies Osteo Arthritis 01 06 Pipeline Rheumatoid Arthritis 01 04 Enrollment Nov’08 Hepatitis 03 10 Enrollment-Dec’08, 2 study-Pipeline Paediatric Psoriasis 01 03 Pipe Line Total Hip Replacement 01 06 Q1-09 Medical device 01 02 Q1-09 Allergic Rhinitis 01 05 Feasibility stage Diabetes 02 11 1 study-Q1-09, 1 pipeline Oncology 04 20 2 studies-Q4-08, 1 study-Q1-09 & 1 study-pipeline Gastroenterology 01 05 Q1-09 Gynecology 01 10 Feasibility stage
  • Our Investigator Pool Sovereign Health has an extensive database of over 600 highly experienced Investigators from the following therapeutic areas: Cardiology (50) Nephrology (26) Critical care (18) Neurology (45) Dental (35) Orthopaedics (70) Dermatology (30) Ophthalmology (30) Diabetology (45) Oncology (170) Endocrinology (45) Psychiatry (50) Gastroenterology (28) Urology (15) Gynecology (30) Internal Medicine (30)
  • 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
  • What makes us different? 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.
  • What makes us different? 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 with the SOPs and ICH GCP and other regulatory guidelines before being placed at the respective sites. We recruit local personnel as 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.
  • What Makes us different? 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.
  • What Makes us different? Internal Monitoring The fact that we conduct internal monitoring visits at our sites prior 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 Data Clarification Forms have been resolved. This activity of our SMO saves time and effort of the Sponsor / CRO personnel and also helps the study conduct with minimum DCFs being generated.
  • What Makes us different? Client satisfaction 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.
  • What Makes us different? Client satisfaction This is the reason behind the massive expansion of SovHealth’s therapeutic 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.
  • What Makes us different? 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 sites and clients.
  • Success of Clinical Trials depends on Good information flow Open communication Channels among participants
  • Contact Us For all business related queries please contact Mr. Suraj Shaw (Business Development Executive-Clinical Research) at s.shaw@sovhealth.com or +91-9311423408
  • Sovereign Health A partner in your study success Thanks ! www.sovhealthindia.com