Clinical Study Protocols, Reportsand Research Papers for Nutraceuticals  AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
Vedic. Introduction2       A decade of experience as full and functional service CRO       Widest range of services for ...
Vedic. Services3
Vedic. Study Outlines4       Study Outlines for global clients: 265       Indications served: Cardiac health, metabolic ...
Vedic. Study Outlines5
Vedic. Investigator Brochure6       A detailed document containing pre-clinical and clinical        information related t...
Vedic. Protocols7        A document that describes –          The objective(s), design, methodology, statistical consider...
Vedic. Protocols8
Vedic. Case Report Form9       Structured for accurate data compilation       Reviewed for detailed comparison with prot...
Vedic. Informed Consent Form10        Non – technical language        Easy to understand        Comprehensive informati...
Vedic. Diary11        Concise and user friendly        Detailed instructions for correct data capture        Translated...
Vedic. Clinical Study Reports12         A written description of a trial/study of any therapeutic,         prophylactic, o...
Vedic. Clinical Study Reports13
Vedic. Statistical Analysis14        Robust statistical analysis plans        Formulation of appropriate research questi...
Vedic. Manuscript15        Journal database        ICMJE guidelines        Herbal CONSORT guidelines        Effective ...
Vedic Research Papers. Published16     Therapeutic Area                Title                             Journal     Joint...
Vedic Research Papers. Published17     Therapeutic Area                 Title                            Journal     Joint...
Vedic Research Papers. Submitted18Therapeutic Area    Title                                         JournalMale Sexual    ...
Vedic. The Team19           Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been           ...
Vedic. The Team20             Dr. Bhakti Shinde has been vital in designing and development of essential             docum...
Vedic. Advisory Board21           Dr. Arun Nanivadekar has had an impressive career spanning 3 decades and           winni...
Vedic. Advisory Board22           Dr. Vinayak Kale currently holds the esteemed position of Director of Medicine          ...
Vedic. Social Media23
24                               India      203, Morya Landmark 1, Off new Link Road, Andheri West,                       ...
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Clinical Study Protocols, Reports and Research Papers for Nutraceuticals

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Clinical Studies for Nutraceuticals and Pharmaceuticals need to be designed and reported as per internationally recognized guidelines like ICH for the data to be globally accepted in today's stringent regulatory environments.

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Clinical Study Protocols, Reports and Research Papers for Nutraceuticals

  1. 1. Clinical Study Protocols, Reportsand Research Papers for Nutraceuticals AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
  2. 2. Vedic. Introduction2  A decade of experience as full and functional service CRO  Widest range of services for the Dietary Supplements, Nutraceuticals, Botanical Drug Products, Medical Foods, Natural Health Products, Cosmetics & Personal Care Products  Clinical Trials for label claim substantiation  Compliant data to meet regulatory requirements  Product development support  ISO 9001:2008 certified  Headquarters in Mumbai, India with office in California, USA
  3. 3. Vedic. Services3
  4. 4. Vedic. Study Outlines4  Study Outlines for global clients: 265  Indications served: Cardiac health, metabolic function, joint health, skin care, hair care, prostrate health, Gastro-intestinal health, oxidative stress, lifestyle diseases  Efficient study designs for claims substantiation  Cost effective study plan  Adaptive trial designs
  5. 5. Vedic. Study Outlines5
  6. 6. Vedic. Investigator Brochure6  A detailed document containing pre-clinical and clinical information related to a test product  IBs completed: 44  Extensive literature search  Prepared by knowledge engineers from Vedic
  7. 7. Vedic. Protocols7 A document that describes –  The objective(s), design, methodology, statistical considerations and organization of a trial  Gives the background and rationale for the trial  Protocols completed: 44  Intellectual and creative team involving clinical experts, statisticians, protocol editors, and regulatory affair officers  High-quality, comprehensive clinical trial protocols  Clearly defined and achievable end-points  Use of validated questionnaires  Accurate version control for evolving drafts
  8. 8. Vedic. Protocols8
  9. 9. Vedic. Case Report Form9  Structured for accurate data compilation  Reviewed for detailed comparison with protocol  Entry and format validation before finalization  No duplication of data  Flexibility in formats: Visit or study parameter  User friendly with annotations
  10. 10. Vedic. Informed Consent Form10  Non – technical language  Easy to understand  Comprehensive information to form a rational decision  Translations in local languages  Back translation certificates; if required
  11. 11. Vedic. Diary11  Concise and user friendly  Detailed instructions for correct data capture  Translated in local languages
  12. 12. Vedic. Clinical Study Reports12 A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report  CSRs completed: 36  ICH E3 and Regulatory compliant  Collaborative writing process  Effective interpretation of statistical results  Accurate version control for evolving drafts
  13. 13. Vedic. Clinical Study Reports13
  14. 14. Vedic. Statistical Analysis14  Robust statistical analysis plans  Formulation of appropriate research question (study hypothesis)  Precise estimation of sample size  Reliable and sensitive statistical methods  Use of validated software  Compliance with ICH & regulatory requirements  Performed by appropriately trained personnel  Verified by expert Biostatisticians
  15. 15. Vedic. Manuscript15  Journal database  ICMJE guidelines  Herbal CONSORT guidelines  Effective reviewing and revising by industry experts  Harmonious integration of heterogeneous input  Regular updates and efficient coordination  Research papers published in International peer- reviewed journals
  16. 16. Vedic Research Papers. Published16 Therapeutic Area Title Journal Joint Health Comparison of Glucosamine Sulfate BMC, Complementary and a polyherbal agent for the and Alternative BMC CAM relief of osteoarthritis of the knee Medicine Joint Health Early relief of osteoarthritis Journal of symptoms with a natural mineral Inflammation Journ of Infl supplement and a herbomineral combination: A randomized controlled trial Sexual Health Efficacy and safety of two American Journal of polyherbal preparations in male Therapeutics AJT 1 sexual dysfuction
  17. 17. Vedic Research Papers. Published17 Therapeutic Area Title Journal Joint Health Efficacy and safety of a American Journal of herbal agent in moderate to Therapeutics AJT 2 severe symptoms of osteoarthritis: a double-blind randomized placebo Controlled disorders Pain Management A Phase fourth Safety and A Peer-Reviewed Efficacy study of an oral Journal Jour of CTs agent in musculoskeletal disorders
  18. 18. Vedic Research Papers. Submitted18Therapeutic Area Title JournalMale Sexual A double-blind randomized, placebo- International Peer-reviewedHealth controlled study of a polyherbal journal specializing in the preparation in erectile dysfunction publication of studies in sexual medicineLeg Complaints A double-blind randomized, placebo- International Peer- reviewed controlled, cross-over, sequential design journal with a focus on study of a novel intervention for relieving rigorous research in pain, oedema and other leg complaints complementary and alternative medicineDiabetes Mellitus Open label study of a herbal medication One of the oldest peer- as an add-on therapy in diabetes mellitus reviewed journals in India/AsiaDiabetes Mellitus A Double-blind randomized, placebo- International Peer- Reviewed controlled study of a herbal medication in journal in Diabetes care patients inadequately controlled on oral hypoglycemic agents
  19. 19. Vedic. The Team19  Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been involved in product development and international business since 1994. He has a rich experience in regulatory affairs, research and marketing for nutraceutical and phyto- pharmaceutical actives and formulations for the EU and US markets. Trained in Pharmacy and Microbial Engineering from University of Minnesota, Jayesh was responsible for the Biocatalyst and Natural Products technical support and national sales at Boehringer Mannheim India in the early ‘90s. • Dr. Navneet Sonawane is heading the Clinical Research Department. She has 12 years of experience in the field of Medical Science & Clinical Research, which include areas such as Medical Writing, Regulatory Affairs, Project Management & QA. She has successfully headed Global Clinical Studies across various therapeutic segments. During her tenure at Vedic, she has developed a strong network of GCP trained clinical investigators around India and has been appreciated by Sponsors around globe. She places a high premium for meeting time line while ensuring delivering of quality.
  20. 20. Vedic. The Team20 Dr. Bhakti Shinde has been vital in designing and development of essential documents like study outline, protocol, investigators brochure and clinical study reports. She has to her credit original research articles published in various international peer reviewed journals. Dr. Shinde has worked on a number of therapeutic indications like, Osteoarthritis, Diabetes Mellitus, Sexual dysfunction, Hypertension and dermatological indications. Dr. Anuradha Kulkarni has been actively involved in creating a strong scientific base for our innovative research methodologies. Her intense research skills supported by sound clinical knowledge have facilitated the development of a variety of high quality scientific documents Dr. Shivjaya Parwar plays a pivotal role in writing and editing of scientific and regulatory documents. With her industry knowledge, she has been instrumental in devising effective medical and scientific communications.
  21. 21. Vedic. Advisory Board21 Dr. Arun Nanivadekar has had an impressive career spanning 3 decades and winning him industry accolades for his contribution to the field of Clinical Research Methodology, Biostatistics, and Medical Communications. Doctor of Medicine (Pharmacology), Master of Science (Medical Faculty), Bachelor of Medicine and Bachelor of Surgery (MBBS), Dr. Nanivadekar at Vedic will provide strategic insights to create innovative study design and project management. Dr. Rahul Chakor is a practicing Neurologist, Neurosurgeon, Brain / Nerve Specialist. He has completed his Fellowship in Clinical Neurophysiology and Epilepsy from Cleveland Clinic, USA. Dr. Chakor will oversee the study protocol of trials connected with Neurology and review the data compiled. Dr. Sanjay Chopda is a practicing cardiologist and has an extensive clinical and research experience of over 17 years in interventional cardiology. He has written and submitted papers in annual conferences on various topics related to cardiac care. Dr. Chopda will oversee the development of protocols for cardiovascular disorders and cardiovascular devices and review the data compiled.
  22. 22. Vedic. Advisory Board22 Dr. Vinayak Kale currently holds the esteemed position of Director of Medicine Department and In charge of Diabetes Unit at an accredited hospital in Pune, India. A Bachelor of Medicine and Bachelor of Surgery ( MBBS ), Diplomate of National Board ( DNB ). A practicing endocrinologist, Dr. Kale will oversee the study protocol of trials connected with Diabetes and review the data compiled. Dr. Erande, Doctor of Medicine (MD) has completed his Post Graduate Diploma in Diabetes from Australia. He is a practicing consultant at his Diabetes Centre and Insulin Pump Clinic established in Pune, India.
  23. 23. Vedic. Social Media23
  24. 24. 24 India 203, Morya Landmark 1, Off new Link Road, Andheri West, Mumbai 400053 Tel.: +91 22 42172300 / +91 22 42025719 USA 552, Shorebird Circle, Unit #1101, Redwood Shores, CA. 94065 Tel.: (650) 855-4832 bizdev@vediclifesciences.com, www.vediclifesciences.com

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