Vedic Lifesciences Pvt Ltd

Vedic Lifesciences Pvt Ltd: 

Vedic Lifesciences Pvt Ltd Corporate Overview

Vedic Lifesciences Synopsis: 

Vedic Lifesciences Synopsis Vedic has so far supported over 34 clinical studies (Phase II/ III) and more than 248 preclinical Studies across multiple therapeutic areas. Core offerings entail Preclinical Studies, Project Management (Phase I to IV), Clinical Data Management, Bio-Statistics, Medical Writing & Regulatory Consulting. Founded in 2001, Vedic is a contract research organization that provides broad-based yet highly tailored drug development & support services to global Pharma, biotech and Lifesciences players. www.vediclifesciences.com

Vedic Synopsis: 

Vedic Synopsis Pre Clinical Services Consultancy Clinical Trials (Phase I-IV) Clinical Data Management Bio Statistics Medical Writing Regulatory Consultancy Other Services Preclinical Consultancy Feasibility Evaluation Study analysis & Protocol Study Set – up & Audits Experimental & Project Management GAP analysis Feasibility CMC Analytical Development & Validation Formulation Development Study Feasibility Analysis Investigator / Site Selection Regulatory Submission & Approval (IRB/EC & DCGI) Site Initiation Assessment Visits Site Management & Monitoring Investigational Product Management Closeouts Query Resolution Data Validation Database Design Data Entry & Tracking Data Coding Database Access Management Data Management Reporting Risk & Query management Clinical Trial Design Sample Size Calculation Statistical Analysis Plans Planning & Execution of interim analysis Final Statistical Analysis Statistical Report Study Design/ Outline Protocol & its Amendments Informed Consent Document Patient Diary and Subject Emergency Card Clinical / Statistical study Report Publication Support Strategic regulatory planning for specific countries Pre – IND meetings INDs NDA and ADNA Applications for marketing license SAE collection, evaluation, classification & reporting Medical case reviews Adverse event narration & coding Pharmacovigilance BA/BE studies Biochemical Assays www.vediclifesciences.com

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Proficiency in Pre Clinical www.vediclifesciences.com FR&D = Formulation & Development AP = Animal Pharmacology RD = Regulatory Documentation AMD = Analytical Method Development TOX = Toxicity Studies ONCO = Oncology

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Proficiency in Clinical Trials www.vediclifesciences.com

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www.vediclifesciences.com Proficiency in Clinical Trials

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www.vediclifesciences.com Proficiency in Clinical Trials

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Our Investigational Partners www.vediclifesciences.com

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Our reach www.vediclifesciences.com

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Our therapeutic focus Orthopedics Enriched experience of 7 trials, Vedic has pool of more 46 investigators with more than 1000 patients load. Vedic has recently completed 2 successful trials. Diabetes Andrology / Urology Oncology Vedic has proficiency of 5 trials. With company of 38 investigators with patients load of more than 1300. Enriched experience of 7 trials, Vedic has pool of more 88 investigators with more than 1500 patients load. On board consultant Dr. M. Conti, well known Oncologist from Italy, is to share his expertise. With 5 Pre clinical project & 43 Investigators, Vedic can carry out any study. 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.

Current Projects: 

Current Projects Andrology: 2 Studies Orthopedics: 1 Study BA /BE: 2 Studies Inflammatory: 1 Study Dermatology: 1 Study Pre Clinical: 6 Studies www.vediclifesciences.com

Key Personnel: 

Key Personnel Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been involved in product development and international business since 1994. He is thorough with 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.

Consultants: 

Consultants

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Clinical Research Coordinator (CRCs): Clean & Quality data Fast Recruitment rate Source Data Verification 100% Start New Sites: Cater all therapeutic areas at higher rate Provide study feasibility report within 36 hours Regulatory Acceptability Publication Acceptability Our Strength www.vediclifesciences.com

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A strategic partner for Clinical Trial Management Our enriched experience for better timelines and quality Professional approach for organizing your innovative research further Clean & Transparent service Competitive cost & Reliable Reports You can count on us for… www.vediclifesciences.com

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Thank You Kindly visit us at www.vediclifesciences.com Contact Us at Dhirendra V. Singh Business Development Manager bizdev@vediclifesciences.com Phone: +91-(0)22-42172300 (D) +91-(0)22-42172317