Vedic Lifesciences Pvt Ltd


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Vedic Lifesciences Pvt Ltd

  1. 1. Vedic Lifesciences Pvt Ltd Corporate Overview
  2. 2. Vedic Lifesciences Synopsis <ul><li>Vedic has so far managed over 34 clinical studies (Phase II/ III) and more than 248 preclinical Studies across multiple therapeutic areas. </li></ul><ul><li>Core offerings include Regulatory Submissions & Consulting, Preclinical Studies, Clinical Project Management (Phase II to IV), Clinical Data Management, Bio-Statistics and Medical Writing </li></ul><ul><li>Founded in 2000, Vedic is a contract research organization that provides broad-based yet highly tailored drug development & support services to global Pharma, Biotech and Lifesciences players . </li></ul>
  3. 3. Vedic Synopsis Pre Clinical Services Consulting Clinical Trials (Phase I-IV) Clinical Data Management Bio Statistics Medical Writing Regulatory Consultancy Other Services <ul><li>Feasibility Evaluation </li></ul><ul><li>Study Protocol & planning </li></ul><ul><li>Experimental & Project Management </li></ul><ul><li>Audits </li></ul><ul><li>GAP analysis </li></ul><ul><li>Feasibility </li></ul><ul><li>Analytical Development & Validation </li></ul><ul><li>Formulation Development </li></ul><ul><li>Study Feasibility Analysis </li></ul><ul><li>Investigator / Site Selection </li></ul><ul><li>Regulatory Submission & Approval (IRB/EC & DCGI) </li></ul><ul><li>Site Initiation </li></ul><ul><li>Assessment Visits </li></ul><ul><li>Site Management & Monitoring </li></ul><ul><li>Investigational Product Management </li></ul><ul><li>Closeouts </li></ul><ul><li>Query Resolution </li></ul><ul><li>Data Validation </li></ul><ul><li>Database Design </li></ul><ul><li>Data Entry & Tracking </li></ul><ul><li>Data Coding </li></ul><ul><li>Database Access Management </li></ul><ul><li>Data Management Reporting </li></ul><ul><li>Risk & Query management </li></ul><ul><li>Clinical Trial Design </li></ul><ul><li>Sample Size Calculation </li></ul><ul><li>Statistical Analysis Plans </li></ul><ul><li>Planning & Execution of interim analysis </li></ul><ul><li>Final Statistical Analysis </li></ul><ul><li>Statistical Report </li></ul><ul><li>Study Design/ Outline </li></ul><ul><li>Protocol & its Amendments </li></ul><ul><li>Informed Consent Document </li></ul><ul><li>Patient Diary and Subject Emergency Card </li></ul><ul><li>Clinical / Statistical study Report </li></ul><ul><li>Publication Support </li></ul><ul><li>Strategic regulatory planning for specific countries </li></ul><ul><li>Pre – IND meetings </li></ul><ul><li>INDs </li></ul><ul><li>NDA and ADNA </li></ul><ul><li>Applications for marketing license </li></ul><ul><li>SAE collection, evaluation, classification & reporting </li></ul><ul><li>Medical case reviews </li></ul><ul><li>Adverse event narration & coding </li></ul><ul><li>Pharmacovigilance </li></ul><ul><li>BA/BE studies </li></ul><ul><li>Biochemical Assays </li></ul><ul><li>Nutraceutical studies </li></ul>
  4. 4. Proficiency in Pre Clinical FR&D = Formulation Development AP = Animal Pharmacology RD = Regulatory Documentation AMD = Analytical Method Development TOX = Toxicity Studies ONCO = Oncology
  5. 5. Proficiency in Clinical Trials
  6. 6. Proficiency in Clinical Trials
  7. 7. Proficiency in Clinical Trials
  8. 8. Our Investigational Partners
  9. 9. Our reach
  10. 10. Our therapeutic focus Orthopedics <ul><li>Enriched experience of 7 trials, Vedic has a pool of more than 46 investigators with more than 1000 patients load. Vedic has recently completed 2 successful trials. </li></ul>Diabetes Andrology / Urology Oncology <ul><li>Vedic has proficiency of 5 studies. With company of 38 investigators with patients load of more than 1300. </li></ul><ul><li>Enriched experience of 7 trials, Vedic has pool of more 88 investigators with more than 1500 patients load. </li></ul><ul><li>With advisor Dr. M. Conti, renowned Oncologist from Italy and 5 Pre-clinical projects & 43 clinical Investigator sites, Vedic can carry out any study. </li></ul>We have recently completed a Disease Surveillance Survey in all Demographics regions of India covering therapeutic areas like Orthopedics, Diabetes, Anthology /Urology, Oncology, HIV, etc.
  11. 11. Current Projects Andrology: 2 Studies Orthopedics: 1 Study BA /BE: 2 Studies Inflammatory: 1 Study Dermatology: 1 Study Pre Clinical: 6 Studies
  12. 12. Key Personnel <ul><ul><ul><li>Jayesh Chaudhary, Founder & Managing Director, has been involved in pharmaceutical development and international business since 1994. Jayesh brings in expertise and leadership skills through the entire drug discovery and development pathway having been involved in several studies hands-on for scientific design or conduct. 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. </li></ul></ul></ul><ul><ul><ul><li>Dr. Aliya Shakeel is responsible for Medical Writing & Regulatory Services. Aliya’s experience in Trial Design and Study Reporting form the basis of Vedic’s Medical Writing department. Her team provides technical & regulatory support to Sponsors and ensures we are constantly innovating in trial design and conduct. Aliya is a qualified physician and trained in clinical research & hospital administration. </li></ul></ul></ul><ul><ul><ul><li>Dhirendra V. Singh has a distinguished career of over four years combining outstanding talent in Clinical Research Project Management, New Business Planning, Risk reduction techniques and high caliber skills in Business Development. Dhirendra has a formal training of Drug discovery at Molecular Hematology & Oncology Research Institute, Germany. His familiarity with Clinical Operations provides a critical support in his role in Business Development at Vedic Lifesciences. With past experience as Project Coordinator and Project Consultant, he has fair knowledge of crafting Business & Marketing Plans and Pre-establishment Market Research. </li></ul></ul></ul><ul><ul><ul><li>Dr. Navneet Sonawane heads Clinical Operations, having 10 years of experience in Clinical Research and practice, which include areas such as Medical Writing, Regulatory Affairs, Project Management & QA. She has successfully headed Global Clinical Trials in Phase 0 to III across diverse therapeutic areas. During her tenure at Vedic, she has developed a strong network of GCP trained clinical investigators around India and her team’s efforts have been appreciated by Sponsors around the globe. She places a high premium on meeting timelines while ensuring quality. </li></ul></ul></ul>
  13. 13. Consultants <ul><ul><ul><li>Dr. Mark Miller had a distinguished career as an academic, pharmaceutical industry researcher, consultant and entrepreneur. His research has made major contributions to numerous fields of medical research. His recent interests centre on the development of therapeutic agents from South American ethno-medicines. He reviews grants for numerous international agencies, editorial reviews for over 40 journals and consults with the World Bank on industry development. </li></ul></ul></ul><ul><ul><ul><li>Dr. Mukesh Kumar leads the Regulatory Affairs Department at Amarex, a USA based CRO. In addition to regulatory expertise, he has experience as a GLP/GCP auditor and as a trainer in business processes. Significant appointments of his career include research scientist at the NIH & Baylor College of Medicine (Houston). Doing research in virology, gene therapy, and molecular biology, he acquired expertise in biological and combination products. </li></ul></ul></ul><ul><ul><ul><li>Dr. Matteo Conti is currently leading the implementation of a brand new Regional Clinical Pharmacology Laboratory (RCPL) in Cesena (Italy). He is an Oncologist and obtained his PhD in Medical Science. While working in IRST, Italy, he was associated with a number of projects and published in the field of Anticancer Pharmacology. His last book “The Selfish Cell” is considered to be a summary of his current views in the field of Oncology. </li></ul></ul></ul><ul><ul><ul><li>Dr. Arun Nanivadekar was formerly Medical Director at Pfizer & Wyeth. He has been a member of Several IRBs/IECs and editorial advisory boards such as the British Medical Journal, Journal of Association of Physicians of India, and Indian Journal of Pharmacology. Since 1997, he has been associated with Academy of Clinical Excellence (ACE), Mumbai, Symbiosis Institute of Health Sciences, and several hospitals. He has been honored with the Lifetime Achievement Award by Indian Society of Clinical Research in 2008, for his contributions to the field of clinical research. </li></ul></ul></ul>
  14. 14. Consultants <ul><ul><ul><li>Dr. Shanta Banerjee is our collaborator and consultant. She is Managing Director of Phytomed Service Germany. She has achieved her PhD degree in Pharmaceutical Chemistry. She has worked as postdoctoral Scientist in renowned research laboratories in Europe and America, before starting her own venture. She has co-author of 30 research publications. </li></ul></ul></ul><ul><ul><ul><li>Dr. Hemant K Singh has been involved in some pioneering work in drug research in India. He has served as Scientist at the Govt. of India premier drug research center, Central Drug Research Institute (C.D.R.I.) for last 30 years. </li></ul></ul></ul><ul><ul><ul><li>Dr. Krishnan Ramaswamy has an illustrious career in Pharmaceutical product development in the US Drug Industry. He pursued his masters & PhD from Purdue University. He started his career in Outcomes Research at Pfizer, as Senior manager. He also worked with Janssen Pharmaceutical, as Associate Director of Outcomes Research. Currently his responsibilities include AIDS relief, grant reviews and project management and research with Infinity Foundation as V.P, R & D. </li></ul></ul></ul>
  15. 15. <ul><li>Clinical Research Coordinator (CRCs): Clean & Quality data </li></ul><ul><li>Fast Recruitment rate </li></ul><ul><li>Source Data Verification 100% </li></ul><ul><li>Start New Sites: Cater all therapeutic areas at higher rate </li></ul><ul><li>Provide study feasibility report within 36 hours </li></ul><ul><li>Regulatory Acceptability </li></ul><ul><li>Publication Acceptability </li></ul>Our Strength
  16. 16. <ul><li>A strategic partner for Clinical Trial Management </li></ul><ul><li>Our enriched experience for better timelines and quality </li></ul><ul><li>Professional approach for organizing your innovative research further </li></ul><ul><li>Clean & Transparent service </li></ul><ul><li>Competitive cost & Reliable Reports </li></ul>You can count on us for…
  17. 17. Thank You Kindly visit us at Contact Us at Jayesh Chaudhary Managing Director [email_address] Phone: +91-(0)22-42172300 (D) +91-(0)22-42172319 (M) +91-(0)9821086665