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Best BABE CRO in India

Veeda CR offers to conduct, manage and monitor Clinical Trials in a wide range of therapeutic areas and monitor BABE studies in India.

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Best BABE CRO in India

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  1. Global Clinical Development Partner Providing Quality Clinical ResearchSolutions

  2. Table OfContents 2 The VeedaAdvantage Infrastructure CorporateOverview People Quality atVeeda Clients andAwards Experience

  3. The VeedaAdvantage 3 ExtensiveScientific Competence toservicea Diverse clientbase IndependentCRO High Customer Centricity andSatisfaction Robust Quality &Regulatory Compliance Skilled personnel withfocus on Continuous Professional Development One stop solution forComplex Studies

  4. 4 CORPORATEOVERVIEW

  5. Evolution 5 Privately owned, board managedcompany New Facility at Mehsana, Total number of Employees970 New Facility atVedant First regulatory inspectionfrom WHO, US FDA & UKMHRA Founded at Shivalikwith 37Employees 2004 2006 First regulatory inspection fromANVISA 2007 2010 • 20152018 • New Facility at Skylar, Exclusively forScreening • CX Partnersjoin 2019 Ahmedabad New Facility atInsignia Corporate Outlook Operational Stability based on experienced professional management and strong qualityculture Focus on Organic and Inorganicgrowth strategies to enhance servicecapabilities Ongoing investments in technology to enhance operating efficiencies and compliance management Financial Stability based on prudent management & Private Equity sponsorship

  6. CorporatePhilosophy 6 MISSION &VISION To strive for Excellence in Quality and Endeavour to become the Partner of choicefor our Sponsors and ourStakeholders VALUES Nurturing Individual Growth Excellence Humility Openness Honesty and Integrity Innovation

  7. QualityStructure 7 “Veeda’s management is committed to continuous improvement in the effectiveness of our Quality culture,to providing quality research solutions that meet sponsor and regulatory requirements and to protecting the rights, safety and well being of the studyvolunteers” Balanced Score Cards (BSC) for augmenting corporatestrategy Quantifiable Performance Metrics for all departments Quality Policy Quality Management System • Comprehensive system with more than 350SOPs • QC & QAmonitoring • Monthly Quality Review Meetings • CAPAManagement Individual KPI’s &KRA’s linked toBSC QualityCulture Continuous process improvement Focus on implementing policies & nurturing individual behavior to sustain our culture ofquality

  8. RegulatoryCredentials 8 • 68 successful regulatory audits tilldate • 26 successful regulatory audits in last 24months 1 33* 3 1 8 1 5 13 3 *FDA : 17 AUDITS FOR PATIENT BASEDSTUDIES 16 AUDITS FOR HEALTHY SUBJECTSSTUDIES

  9. Experience 9 BA/BEstudies 1012Pilot 12 Glucose Clampsstudies (700clamps) Total 3232 19 InhalationStudies 45 SpecialStudies *BothPilot and Pivotal BA/BE 1632Pivotal 588 StandaloneBio-Analytical 4Suppositories 14 FTFStudies 10 PatchesStudies 88 Complex ClinicalStudies Patient basedstudies Type ofStudy TherapeuticSegment No. ofStudies Global multi-centred Phase II clinicaltrials Completed 04 Oncology Ongoing 02 Oncology andCVS PK ClinicalTrials Completed 22 Oncology (14), Psychiatry (6), Rheumatology & Dermatology (1), HIV(1) Ongoing 08 Oncology (6), Psychiatry (1), Gynaecology(1) Phase III studies of injectableimplants 02 Bonedisease Stand-alone Medical writing BE-PKstudies 04 Psychiatry andoncology

  10. 10 INFRASTRUCTURE

  11. Clinical Infrastructure 11 VEDANT Clinical, Bioanalyticalwith administrativeoffices SHIVALIK DedicatedClinical facility Spread across 17clinics Vedant 170 Beds+ 6 Special carebeds INSIGNIA DedicatedBioanalytical facility MEHSANA Clinical andScreening facility Shivalik 170 Beds+ 7 Special carebeds 12 Intensively monitoredbeds to conduct Phase Istudy 502Beds + 20Special carebeds SKYLAR Common screening facility for both Shivalik and Vedant ARCHIVES Internal archival areain eachfacility. Separate long termarchival facility at Mehsana and Unjha Mehsana 162 Beds+ 7 Special carebeds

  12. BioanalyticalInfrastructure 12 • StorageCapacity • PlasmaSample: • 45 Deep freezers with capacity to store 11,25,000samples at -80Cﹾ • IPStorage: • 3 Walking type stability chambers with overallcapacity tostore34000Ltrforretentionatroomtemperature • 4Humiditychamberswithoverallcapacityof3200Ltr • 4 Pharmaceutical refrigerators having storage capacity of3550Ltrat2-8Cﹾ • Archival: Capacity to archive approximately 51000files • 46 LC-MS/MSmachines • Insignia -33 • Vedant -13 • API 5500/4000/3200/3000/2000 • Shimadzu8060/8050/8040 • QuattroPremier • 2ICP-OES • WatsonLIMS

  13. 13 CAPABILITIES

  14. BA/BECapabilities 14 Volunteer Database (More than53,900) MaleVolunteers >47,000 Complexstudies: • Cotinine freestudies • High number of ambulatorysamples • Long Washoutperiods FemaleVolunteers >3,800 ElderlyMales >1,600 Post - MenopausalFemales >1,500 FTFstudies • Routes ofadministration • 20 different dosageforms • Inhalation • Transdermal Patches • Rectal/Vaginalsuppositories • Orals • Glucoseclamps • LAIs Intensive SafetyMonitoring

  15. Patient Trialscapabilities 15 TherapeuticExpertise Oncology Psychiatry • Chronic myeloid leukaemia(CML) • Metastatic BreastCancer • Non – small cell lung cancer(NSCLC) • Renal cell carcinoma(RCC) • ColorectalCancer • Small cell lung cancer(SCLC) • Ovarian Cancer • Schizophrenia • Epilepsy • Alzheimer Clinical End point studies Phase II /Phase III studies Cardiology, Immunology (HIV), Dermatology,Rheumatology, Gastroenterology, Orthopaedics Ophthalmology, ENTetc PK / PDEnd point studies Diverse Routes of administration • Extensive Investigators network and experienced project managementteam • eCTD compilation and datamanagement

  16. BioanalyticalCapabilities 16 Types ofMethods Total available Bioanalytical methods are more than850 • State of theart • Capability to develop methods withlowest quantification level- up to 0.1pg • Methods developedfor: 731+ 19 63 Complex Generics+ PD/IM • Endogenousmolecules • Hormones • Steroids • Inhalationformulation • ElementalBioanalysis • Immunogenicity • Large molecules/ECLIA/ELISA 63 27 NCEs MD/MV • Multiple analysis in singleinjection • Central labs for Phase II /Phase III studies • Tissue distributionstudies Bioanalytical SalientFeatures • Average capacity of 1,00,000samples per month • Central BioanalyticalLaboratory

  17. Biopharmaceutics and ProjectManagement 17 StudyDesigning Regulatory eCTDcompilation MedicalWriting PK and stats Data evaluation

  18. Training &Development 18 People 12 Continuous Professional Development (CPD)program topics/year/department 5 6 P HD Dedicated Training Laboratory withworld classfeatures MD ACLS/BLS training conducted everyquarter eModules Training done throughiPads 22 M B BS 715 GCP/GLP training conducted externally once every year SOP training conducted on an ongoingbasis OTHERS

  19. 19 CLIENTS ANDAWARDS

  20. Clientele 20 Revenue Generation by ClientSize OverallCustomer RetentionRate >90% Large size / MNC(s) Mid-Size Clients 30% 36% Small Clients 34% 90% of the revenue comes from Existingclients TotalClients 9ROW 142130 Clients Active in the Pastyear 3ROW 58 41 India US India US 54 19 EU 89 16 EU China China

  21. Achievements 21 14+ 2017 2019 2018 2004 Y E A RS Organization AwardCategory Organization AwardCategory National ExcellenceAward Best Quality Clinical Research Organization in India Best PharmaceuticalCRO Health & SafetyAwards Best Clinical Research-India Best Quality Clinical Research Organization in India Best Clinical Research- India Mark ofExcellence Indian Clinical Research company of theyear

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