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.

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

2. Vedic. Introduction
2
 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. Vedic. Services
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4. Vedic. Study Outlines
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 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. Vedic. Study Outlines
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6. Vedic. Investigator Brochure
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 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. Vedic. Protocols
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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. Vedic. Protocols
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9. Vedic. Case Report Form
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 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. Vedic. Informed Consent Form
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 Non – technical language
 Easy to understand
 Comprehensive information to form a rational decision
 Translations in local languages
 Back translation certificates; if required

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

12. Vedic. Clinical Study Reports
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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. Vedic. Clinical Study Reports
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14. Vedic. Statistical Analysis
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 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. Vedic. Manuscript
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 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. Vedic Research Papers. Published
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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. Vedic Research Papers. Published
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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. Vedic Research Papers. Submitted
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Therapeutic Area Title Journal
Male Sexual A double-blind randomized, placebo- International Peer-reviewed
Health controlled study of a polyherbal journal specializing in the
preparation in erectile dysfunction publication of studies in
sexual medicine
Leg 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 medicine
Diabetes 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/Asia
Diabetes 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. Vedic. The Team
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 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. Vedic. The Team
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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. Vedic. Advisory Board
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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. Vedic. Advisory Board
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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. Vedic. Social Media
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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