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AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH Clinical Study Protocols, Reports and Research Papers for Nutraceuticals 1.

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Presentation on theme: "AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH Clinical Study Protocols, Reports and Research Papers for Nutraceuticals 1."— Presentation transcript:

1 AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH Clinical Study Protocols, Reports and Research Papers for Nutraceuticals 1

2 Vedic. Introduction  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 2

3 Vedic. Services Services Regulatory Dossier Preparation & Consulting Preclinical Formulation and Standardization Toxicology In vitro & In vivo Animal studies Clinical Human Bioavailability Studies Human Clinical Studies Medical Writing 3

4 Vedic. Study Outlines  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 4

5 Vedic. Study Outlines 5

6 Vedic. Investigator Brochure  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 6

7 Vedic. Protocols 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 7

8 Vedic. Protocols 8

9 Vedic. Case Report Form  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 9

10 Vedic. Informed Consent Form  Non – technical language  Easy to understand  Comprehensive information to form a rational decision  Translations in local languages  Back translation certificates; if required 10

11 Vedic. Diary  Concise and user friendly  Detailed instructions for correct data capture  Translated in local languages 11

12 Vedic. Clinical Study Reports 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 12

13 Vedic. Clinical Study Reports 13

14 Vedic. Statistical Analysis  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 14

15 Vedic. Manuscript  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 15

16 Vedic Research Papers. Published Therapeutic AreaTitleJournal Joint HealthComparison of Glucosamine Sulfate and a polyherbal agent for the relief of osteoarthritis of the knee BMC, Complementary and Alternative Medicine Joint HealthEarly relief of osteoarthritis symptoms with a natural mineral supplement and a herbomineral combination: A randomized controlled trial Journal of Inflammation Sexual HealthEfficacy and safety of two polyherbal preparations in male sexual dysfuction American Journal of Therapeutics 16

17 Vedic Research Papers. Published Therapeutic AreaTitleJournal Joint HealthEfficacy and safety of a herbal agent in moderate to severe symptoms of osteoarthritis: a double-blind randomized placebo Controlled disorders American Journal of Therapeutics Pain ManagementA Phase fourth Safety and Efficacy study of an oral agent in musculoskeletal disorders A Peer-Reviewed Journal 17

18 Vedic Research Papers. Submitted Therapeutic AreaTitleJournal Male Sexual Health A double-blind randomized, placebo- controlled study of a polyherbal preparation in erectile dysfunction International Peer-reviewed journal specializing in the publication of studies in sexual medicine Leg ComplaintsA double-blind randomized, placebo- controlled, cross-over, sequential design study of a novel intervention for relieving pain, oedema and other leg complaints International Peer- reviewed journal with a focus on rigorous research in complementary and alternative medicine Diabetes MellitusOpen label study of a herbal medication as an add-on therapy in diabetes mellitus One of the oldest peer- reviewed journals in India/Asia Diabetes MellitusA Double-blind randomized, placebo- controlled study of a herbal medication in patients inadequately controlled on oral hypoglycemic agents International Peer- Reviewed journal in Diabetes care 18

19 Vedic. The Team 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. 19

20 Vedic. The Team 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. 20

21 Vedic. Advisory Board 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. 21

22 Vedic. Advisory Board 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. 22

23 Vedic. Social Media 23

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, 24

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