vedic lifesciences pvt ltd

Vedic Lifesciences Pvt LtdCorporate Overview

Vedic Lifesciences SynopsisVedic has so far managed over 34 clinical studies (Phase II/ III) and more than 248 preclinical Studies across multiple therapeutic areas.

Core offerings include Regulatory Submissions & Consulting, Preclinical Studies, Clinical Project Management (Phase II to IV), Clinical Data Management, Bio-Statistics and Medical Writing

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.

www.vediclifesciences.com

http://www.vediclifesciences.com/

Vedic SynopsisPre Clinical Pre Clinical

ServicesServicesConsultingConsulting

Clinical TrialsClinical Trials(Phase I-IV)(Phase I-IV)

Clinical DataClinical DataManagementManagement

BioBioStatisticsStatistics

Medical Medical WritingWriting

RegulatoryRegulatoryConsultancyConsultancy

Other Other ServicesServices

Feasibility Feasibility EvaluationEvaluation

Study Study Protocol & Protocol & planningplanning

Experimental Experimental & Project & Project Management Management

AuditsAudits

GAP analysisGAP analysis

FeasibilityFeasibility

Analytical Analytical Development Development & Validation& Validation

Formulation Formulation DevelopmentDevelopment

Study Study Feasibility Feasibility AnalysisAnalysis

Investigator / Investigator / Site SelectionSite Selection

Regulatory Regulatory Submission & Submission & Approval Approval (IRB/EC & (IRB/EC & DCGI)DCGI)

Site InitiationSite Initiation

Assessment Assessment VisitsVisits

Site Site Management Management & Monitoring& Monitoring

Investigational Investigational Product Product ManagementManagement

CloseoutsCloseouts

Query Query ResolutionResolution

Data Data ValidationValidation

Database Database DesignDesign

Data Entry & Data Entry & TrackingTracking

Data CodingData Coding

Database Database Access Access ManagementManagement

Data Data Management Management ReportingReporting

Risk & Query Risk & Query managementmanagement

Clinical Trial Clinical Trial DesignDesign

Sample Size Sample Size CalculationCalculation

Statistical Statistical Analysis Analysis PlansPlans

Planning & Planning & Execution of Execution of interim interim analysisanalysis

Final Final Statistical Statistical AnalysisAnalysis

Statistical Statistical Report Report

Study Design/ Study Design/ OutlineOutline

Protocol & its Protocol & its AmendmentsAmendments

Informed Informed Consent Consent DocumentDocument

Patient Diary Patient Diary and Subject and Subject Emergency Emergency CardCard

Clinical / Clinical / Statistical Statistical study Reportstudy Report

Publication Publication SupportSupport

Strategic Strategic regulatory regulatory planning for planning for specific specific countriescountries

Pre – IND Pre – IND meetingsmeetings

INDsINDs

NDA and NDA and ADNAADNA

Applications Applications for marketing for marketing license license

SAE SAE collection, collection, evaluation, evaluation, classification classification & reporting& reporting

Medical case Medical case reviewsreviews

Adverse event Adverse event narration & narration & coding coding

PharmacovigilPharmacovigilanceance

BA/BE studiesBA/BE studies

Biochemical Biochemical AssaysAssays

Nutraceutical Nutraceutical studiesstudies


Proficiency in Pre Clinical


7

48

5660

72

50

10

20

30

40

50

60

70

80

FR&D AP RD AMD TOX ONCO

No.Of Studies

FR&D = Formulation DevelopmentAP = Animal PharmacologyRD = Regulatory DocumentationAMD = Analytical Method DevelopmentTOX = Toxicity StudiesONCO = Oncology

Proficiency in Clinical TrialsNumber of Trials

5

7

112222

7

1 4

DiabetesOrthopedicsRespiratory DisorderLifestyle DiseasesCardiovascular DiseasesDermatologyGastrointestinalHIV (Phase 0)Urology/AndrologyNeurologyOthers


Number of Subjects

340

800

150

60

120

80

110

50

680

60

240

Diabetes

Orthopedics

Respiratory Disorder

Lifestyle Diseases

Cardiovascular Diseases

Dermatology

Gastrointestinal

HIV (Phase 0)

Urology/Andrology

Neurology

Others

No. of subjs


Proficiency in Clinical Trials


Number of sites

16

33

925252

50

2 10

Diabetes

Orthopedics

Respiratory Disorder

Lifestyle Diseases

Cardiovascular Diseases

Dermatology

Gastrointestinal

HIV (Phase 0)

Urology/Andrology

Neurology

Others


Proficiency in Clinical Trials

Our Investigational Partners

4326

2088

4638

2740

2118

2212

1015

1036

0 15 30 45 60 75 90



Our reach



Our therapeutic focusOrthopedicsOrthopedics

Enriched experience of 7 trials, Vedic has a Enriched experience of 7 trials, Vedic has a pool of more than 46 investigators with pool of more than 46 investigators with more than 1000 patients load. Vedic has more than 1000 patients load. Vedic has recently completed 2 successful trials.recently completed 2 successful trials.

DiabetesDiabetes

Andrology /Andrology /UrologyUrology

Oncology Oncology

Vedic has proficiency of 5 studies. With Vedic has proficiency of 5 studies. With company of 38 investigators with patients company of 38 investigators with patients load of more than 1300. load of more than 1300.

Enriched experience of 7 trials, Vedic has Enriched experience of 7 trials, Vedic has pool of more 88 investigators with more pool of more 88 investigators with more than 1500 patients load.than 1500 patients load.With advisor Dr. M. Conti, renowned With advisor Dr. M. Conti, renowned Oncologist from Italy and 5 Pre-clinical Oncologist from Italy and 5 Pre-clinical projects & 43 clinical Investigator sites, projects & 43 clinical Investigator sites, Vedic can carry out any study.Vedic can carry out any study. We have recently completed a Disease Surveillance We have recently completed a Disease Surveillance

Survey in all Demographics regions of India Survey in all Demographics regions of India covering therapeutic areas like Orthopedics, covering therapeutic areas like Orthopedics, Diabetes, Anthology /Urology, Oncology, HIV, etc.Diabetes, Anthology /Urology, Oncology, HIV, etc.

Current ProjectsAndrology:Andrology:2 Studies2 StudiesOrthopedics: Orthopedics:

1 Study1 Study

BA /BE:BA /BE:2 Studies2 Studies

Inflammatory: Inflammatory: 1 Study1 Study

Dermatology:Dermatology:1 Study1 Study

Pre Clinical: Pre Clinical: 6 Studies6 Studies



Key Personnel• 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.

• 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.

• 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.

• 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.

Consultants

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Consultants

• 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.

Clinical Research Coordinator (CRCs): Clinical Research Coordinator (CRCs): Clean & Quality dataClean & Quality dataFast Recruitment rateFast Recruitment rateSource Data Verification 100%Source Data Verification 100%Start New Sites: Cater all therapeutic Start New Sites: Cater all therapeutic areas at higher rate areas at higher rate Provide study feasibility report within 36 Provide study feasibility report within 36 hourshoursRegulatory AcceptabilityRegulatory AcceptabilityPublication Acceptability Publication Acceptability

Our Strength



A strategic partner for Clinical Trial A strategic partner for Clinical Trial ManagementManagement

Our enriched experience for better Our enriched experience for better timelines and qualitytimelines and quality

Professional approach for organizing Professional approach for organizing your innovative research further your innovative research further

Clean & Transparent serviceClean & Transparent service

Competitive cost & Reliable ReportsCompetitive cost & Reliable Reports

You can count on us for…



Thank YouKindly visit us

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Contact Usat

Jayesh ChaudharyManaging DirectorManaging Director

[email protected] Phone: +91-(0)22-42172300 (D) +91-(0)22-42172319 (M) +91-(0)9821086665

vedic lifesciences pvt ltd

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