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Axis Clinicals Corporate Presentation

AXIS Clinicals, a privately owned well established full-service CRO (Contract Research Organization) headquartered in Hyderabad, India<br>

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Axis Clinicals Corporate Presentation

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  1. A Promiseto Precisionin Clinical Trials

  2. Vision/Mission •Tobe thepreferred,trustedand valued Clinicaldevelopmentpartner forglobalpharmaceutical& biotechnologycompanies. •Knownasan Integratedhealthservice providerofchoice. •Deliver sophisticatedclinicalresearch services withoutcompromisingqualityortimelines. APromisetoPrecisioninClinicalTrials

  3. Overview  Establishedin Sept.2004. CentralHeadquartersatHyderabad,India. Facilitiesin4 Countries(India, US, MexicoandThailand) andmorethan500+professionalsoperatingworldwide. FullyCompliantwithICHGCP,ICMR,MexicanCOFEPRIS, ThaiFDAandSchedule–YGuidelines. CombinedClinicalbedStrengthof570+,supportedby32 LC-MS/MSinstruments,withmorethan300+validated analyticalmethods. Morethan55,000activestudyparticipantsinglobal database. Over80%business:Repeatbusiness.      LeadingGlobalClinicalResearch organizationacceleratingtheDrug Development.  APromisetoPrecisioninClinicalTrials

  4. Overview… Experience:    9+yearsofBiopharmaceuticalexperienceforGlobalclients. 70+PharmaandBiotechSponsorsallovertheglobe. 1800+successfulclinicalstudies. Consistency:   Less than5%attritionYOY. Morethan80% RepeatBusiness. GlobalFootprints:   Operations:India,USA,MexicoandThailand. OfficesinIndia, USA,MexicoandThailand. APromisetoPrecisioninClinicalTrials

  5. Global Regulatory Accreditations- Milestones 2015 2014 ANVISA-Brazil: March WHO: March 2013 Thai-GLP:January USFDA: March ANVISA-Brazil:June 2012 ANVISA– Brazil: August USFDA:August UK-MHRA: September ANVISA– Brazil: October. USFDA:October. US-FDA: February. US-FDA: March. US-FDA: October. ANVISA-Brazil : August. UK-MHRA: October. Turkey-MOH:December. 2011 2010 US-FDA: May. US-FDA: June. 2009 UK-MHRA:February. FRENCH-AFSSAPS: June. ANVISA-Brazil: October. US-FDA: October. US-FDA:March. US-FDA:October. 2008 2007 NABL :January. ANVISA-Brazil : August. APromisetoPrecisioninClinicalTrials

  6. Capabilities/ PK/PDstudies Expertise @ AXIS ClinicalResearch            Bioequivalence/Bioavailabilitystudies Pharmacokinetic/Pharmacodynamic studiesinHealthysubjects Special/PatientPopulationstudies. Foodeffect/Drug–DrugInteraction studies. ProofofConceptstudies. End-toEndService -ProtocoltoReport ProjectManagement FinalsubmissionReport(eCTD/ICHE3) PhaseII-IVtrials PK/PDStudiesin patients FeasibilityStudies ProjectPlanningand Setup StudyDesignandProtocolWriting RegulatoryApprovals Design&DevelopmentofCRF/eCRF ProjectManagement Site/InvestigatorIdentificationand Selection SiteMonitoring SiteManagement QualityAssurance/AuditServices           APromisetoPrecisioninClinicalTrials

  7. Capabilities/ Expertise@ AXIS ClinicalDataManagement … Biostatistics&Medical Writing SampleSizeandPowerCalculation Medicalwritingandliteraturesearch ProvidingStatisticalInputsduring ProtocolDesigning Randomization StatisticalAnalysisPlan(SAP) SASProgrammingandValidation InterimAnalysis StatisticalReport       DataManagementPlan DatabaseDesign&Development Double-DataEntry QueryManagement MedicalCoding,SAEDataReconciliation Edit,ValidationandDesigncheck programming DataValidation DataCleaning QualityControlandDataQualityAudits DatabaseLockandExporttoSAS CleanDataFiles ProjectDataArchivalandStorage       APromisetoPrecisioninClinicalTrials

  8. Capabilities/ Expertise @ AXIS … StandAlone Services        RegulatoryServices. CentralReferenceLabServices. BioAnalyticalServices. MetalIonanalysis. Biostatistical&MedicalWriting. QualityAssurance. ClinicalDataManagement. APromisetoPrecisioninClinicalTrials

  9. Credentials RegulatoryInspections& Approvals   Successfullycompleted45+regulatoryauditsbyIndianandInternationalregulatorybodies Completed70+NationalandInternationalsponsor audits ProductApprovals UK MHRA Brazil ANVISA USFDA WHO Canada FranceAFSSAPS Turkey MOH South Africa Australia WHO Thai GLP MexicoMOH Malaysia NABL India APromisetoPrecisioninClinicalTrials

  10. Bio-studiesExperience : Geographical Submissions France,6 Turkey,18 Korea,30 Australia,69 Brazil,78 Russia,3 India,3 WHO,15 US,1153 Canada,124 Europe,337 StudiesCompleted =1836 APromisetoPrecisioninClinicalTrials

  11. ClinicalPharmacology: IndiaOperations India     292Bedsarrangedin7 studyareasin 2 locations. 1,90,000sq.ftarea. 7 IntensiveCareUnitswithcardiacmonitoring. Audited&/oraccreditedbyUSFDA,UKMHRA,Brazilian ANVISA,India(DCGI),AFSSAPS,NABLandISO9001:2000. World-classinfrastructuretosupportclinicalactivities. 18LC-MS/MS&3ICP-OESforbioanalysis. Capacitytohandleapprox.2000Clinicaldosings/month. Capabilitytoanalyzeapprox.35,000samples/ month.     APromisetoPrecisioninClinicalTrials

  12. In-House ClinicalReference Laboratory  Testing@ACRL      HematologyandCoagulationAssays Biochemistry ClinicalPathology Immunoassays Histopathology  NABL(NationalAccreditationBoardforTestingand CalibrationLaboratories)accreditedlaboratory AuditedbyBrazilANVISA&UKMHRA   ServicesforClinicalTrialshavingmultiplesites&CROs (StandAloneServicesalsooffered). APromisetoPrecisioninClinicalTrials

  13. BioanalyticalLab  18LC-MS/MS (SCIEXAPI2000,3000,3200,4000,4000Qand5000) 5 HPLC-UV/FluorescentDetectors. 3 ICP-OESforTraceMetalAnalysis. 300+validatedassays. Quantitativeanalysisofparentdrugsandtheir metabolitesin avarietyofbiologicalmatrices. NetworkedChromatographicDataManagement (ScientificDataManagementSystem) SolidPhaseExtractionSystems. NitrogenEvaporators. Capabilitytoanalyse>35,000samples/month.         APromisetoPrecisioninClinicalTrials

  14. BioanalyticalLab…  CriticalassaysdevelopedFirst-in-Asiaforsmallmolecules      ConjugatedEstrogen EsterifiedEstrogens Estradiol EthinylEstradiol &Levonorgestrol ManycombinationsofOralContraceptives  First-in-worldassaysforsmall&largemolecules    Loteprednolin AqueousHumor DexamethasoneinAqueousHumor Testosteronein serum  Criticalassayin developmentandvalidation molecules stageforlarge    Insulin Glucagon Enoxaparin APromisetoPrecisioninClinicalTrials

  15. Expertise(Formulations &Therapeutic Areas) Therapeutic Areas Formulations              Antibiotic/Antimicrobial Antidepressant Antiepileptic Antiretroviral Hormone Hypoglycemicagents Lipidloweringagents Musclerelaxants NSAIDs Narcotics Oralcontraceptive Psychotropicagents OralSolids–Capsules,Tablets, Softgels,Granules,ODT,ODP, ModifiedRelease LiquidOrals Parenterals Transdermalpatches TopicalGel Cream Inhalers NasalSprays        APromisetoPrecisioninClinicalTrials

  16. Quality Systems@ AXIS    DedicatedteamreportingtoQAHead. QualityControl(QC)Proceduresin placeapartfromQualityAssurance(QA)Procedures. AllactivitiesaresubjectedtorigorousreviewforQualityAssuranceincluding    Clinical(over50SOP’s) Bio-analytical PK/Stats/ Reporting     InternalAuditsbyQAteam forAreaSpecificSOPcompliance. In-housecapabilitiestoperformSiteAudits,Systems/ProcessAudit,VendorAudit. DocumentAudits(Protocol,ClinicalStudyReport&essentialClinicalTrialdocuments). AllQAsystemsarecompliantwithall applicablelocal&internationalregulations. APromisetoPrecisioninClinicalTrials

  17. Clinical Research (Phase II–IV)  Phase2-4 ClinicalTrials(NewChemicalEntities)    >450sites >800Investigators Oncology,CNS,Cardiology,Gastrointestinal,Orthopedic, Ophthalmology,Endocrinology&Metabolism    505(b)(2)ClinicalStudies. ClinicalEndPointStudies. PatientPopulationPKStudies, APromisetoPrecisioninClinicalTrials

  18. Experience – Clinical Trials Sr.No. Segment Studyphase Patients/ Currentstatus Sites 1. OPHTHAL PhaseIII 514;10 sites Recruitmentexpectedto completein 90days 2. Gastro PhaseIII 485; 20sites Recruitmentexpectedto completein 180days 3. CNS ClPK study 28; 2sites Recruitmentexpectedto completein 45days 4. CVS ClPK study 32; 2sites Recruitmentexpectedto completein 50days 5. Onco ClPK PD study 30; 5sites Recruitmentexpectedto completein 50days 6. Onco ClPKPDstudy 120;20 sites Recruitmentexpectedto completein 60 days 7. CNS ClPK study 28; 2 sites Recruitmentcompletedwithin50 days 8. CNS ClPK study 40; 3 sites Recruitmentcompletedwithin81 days 9. CNS ClPK study 26; 4 sites Recruitmentcompletedwithin79 days 10. CNS ClPK study 34; 2 sites Recruitmentcompletedwithin170 days 11. URO PhaseIIa 180; 8sites Recruitmentcompletedwithin120 days 12. CNS ClPK study 42; 4 sites Recruitmentcompletedwithin75 days APromisetoPrecisioninClinicalTrials

  19. Clinical Data Management &Biostatistics             OracleClinical®v4.6withRemoteDataCapture ProjectSpecificClinicalDataManagementPlan CustomizedDatabaseDesign&Development IndependentDouble-DataEntry QueryManagement MedicalCoding,SAEDataReconciliation Edit,ValidationandDesigncheck DataValidation DataCleaning QualityControlandDataQualityAudits DatabaseLockandExporttoSAS DocumentationCDMReport APromisetoPrecisionin ClinicalTrials

  20. Support Teams at Axis ProjectManagementGroup(PMG):DedicatedProject Managersare assigned toeach Client toensure thetimelyexecutionof theprojectsatAXISClinicals. Back up Project Managers helpto maintainthe continuity.  QA Department:ExperiencedpersonneltomaintainQualityofthehighest standards. Validation:AXIShas a dedicatedteamfor Validationand themaintenanceof Scientific equipmentis done on aregularbasis bytheGLPEngineers. Pharmacy:Each of the ClinicalUnitsofAXIShas DedicatedPharmacistsfor the IMPManagement   APromisetoPrecisioninClinicalTrials

  21. Clinical Pharmacology USA      360BedsinCPU 1,20,000sq.ftarea(Dilworth,MN)Dedicated DermatologyResearchCenterExpertisein DermaandControlledsubstances World-classinfrastructuretosupporttheAmerica market&otherRegulatedmarkets. 25+LC-MS/MSforbioanalysis. IndependentProjectManagementGroup.   APromisetoPrecisioninClinicalTrials

  22. Clinical Pharmacology Mexico     100Bedsarrangedin3 studyareas. IntensiveCareUnitswithcardiacmonitoring. DedicatedClinicalReferenceLab. ApprovedbyCofepris(MexicanRegulatory Agency)forClinicalandBioanalyticaloperations. World-classinfrastructuretosupporttheLatin Americamarket&otherRegulatedmarkets. 4 LC-MS/MSforbioanalysis. IndependentProjectManagementGroup.    APromisetoPrecisioninClinicalTrials

  23. ClinicalResearch Thailand       CapabilitiestoconductandmonitorthePhaseII–IVstudies TieupwithHospitalsetupforclinicalstudies SiteManagement ClinicalEndPointStudiesPatientPopulationPKStudiesIndependent ProjectManagementGroup. APromisetoPrecisioninClinicalTrials

  24. The AXIS Edge  EndtoEndserviceproviderwithexperiencedClinicalresearchprofessionalsandExcellent infrastructure. ImpressiveAccreditationsfromInternationalRegulatoryBodies. SuccessfulRegulatoryInspectionstrack record. TeamswithRich professionalExperience. Expertisein variousTherapeuticsegment. AccesstoPatient’sinmajortherapeuticareas. Fast andexcellentTurnaroundtime. CompetitivePricingas comparedtoIndustryPeers. AXIScanhelpyoutofileFTFapplicationin 18–20days. Top5InternationalGenericcompaniesamongthelistofClient’s.          APromisetoPrecisioninClinicalTrials

  25. we CorporateHeadquarter: 1-121/1,Miyapur,Hyderabad500049,INDIA AbhijitChaudhari Director-BusinessDevelopment(India,EU& ROW) abhijit.chaudhari@axisclinicals.com www.axisclinicals.com ThankYou APromisetoPrecisioninClinicalTrials

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