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AleadingglobalLifeScienceCompany

www.cliantha.in

History
2004
FoundedBAResearchIndiaLimited,nowrenamedasClianthaResearchLimited Inauguratedwith122bedsand4LC/MS/MS,CentralReferenceLabaccreditedbyCAP InauguratedanewfacilityatVadodaracity(2hourdrivefromAhmedabad) with200bedsandCAPaccreditedPathLab Bioanalyticallabupgradedto13LC/MS/MS IntroducedTransdermalclinicalstudies IntroducedanewfacilityinAhmedabadwithcapacityof100beds

2007

2009

IntroducedClinicalDataManagementServices Bioanalyticallabupgradedto16LC/MS/MS IntroducedpatientbasedClinicalTrials(PhaseIIIV) Bioanalyticallabupgradedto18LC/MS/MS

2010

2011

ClianthaResearchacquiredHillTopResearch;aleadingCROinUSAandCanadaspecialized inDermatologyRxandPersonalHealthcare.Fordetailslogon:www.hilltop.com EstablishedBA/BEservicesinMexicoCity ICPOESwasaddedtoBioanalyticallab Theexpertise,methodologyandexperienceofourClinicalTrials team inspiredustolaunchafocusedwebsite:www.clianthatrials.com

2012
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Winnipeg

CANADA
MexicoCity St.Petersburg Ahmedabad

INDIA
Vadodara

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SubmissionsandSponsors

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Accreditations&Inspections
GovernmentOfIndia Facilitiesinspected&approved byDrugsControllerGeneralof India RecentinspectioninOct2011 InspectedfacilityinNov2006

RecentinspectioninJune2012

InspectedinFeb2011

InspectedandcertifiedCliantha facilityinMexicoCityinApril2012

InspectedfacilityinJan2009

InspectedfacilityinApril2011

InspectionofDiagnosticlabin Aug2011

RecentinspectionofDiagnosticLabin July,2012

LocationsregisteredinSeptember,2012
2012ClianthaResearchLimited

RegulatoryInspectionsHistory India
ClianthaResearchhasbeensuccessfullyinspectedbyfollowingregulatoryagencies:
Date
Nov0611,2006 May1417,2007 Sep2021,2007 Sep1519,2008 Jan1213,2009 Jun1723,2010 Oct1820,2010 Oct1822,2010 Oct2527,2010 Feb910,2011 April1112,2011 April1315,2011 Oct37,2011 Jun1922,2012

Inspection
AhmedabadHQbyANSM(GCP&GLP) AhmedabadHQbyUSFDA(GCP) AhmedabadHQbyUSFDA(GCP,GLP&Stats) VadodarabyUSFDA(GCP) AhmedabadHQbyMCC(GCP,GLP&Stats) AhmedabadHQbyUSFDA(GLP&Stats) AhmedabadHQbyWHO(GCP,GLP&Stats) AhmedabadSigmabyUSFDA(GCP) AhmedabadHQbyUSFDA(GCP) VadodarabyAGES(GCP) VadodarabyAEMPS(GCP) AhmedabadHQbyAEMPS(GLP&Stats) VadodarabyUSFDA(GCP) AhmedabadHQandSigmabyWHO(GCP,GLP&Stats)

AllthethreelocationsofClianthaResearchLimitedareinspected&approvedbyDrugControllerGeneralofIndia(DCGI) 6
2012ClianthaResearchLimited

RegulatoryInspectionsHistory India
DiagnosticLab:
Date
Sep,2007 Sep,2008 Sep,2009 Sep,2010 Aug,2011 Aug,2011 July,2012

Inspection
ClianthaHQbyCAP ClianthaVadodarabyCAP ClianthaSigmabyCAP ClianthaVadodarabyCAP ClianthaSigmabyCAP ClianthaVadodarabyCAP ClianthaSigmabyANVISA

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RegulatoryInspectionsHistory Mexico
ClianthafacilityinMexicoCityhasbeeninspectedandcertifiedbyCofepris inApril2012andisnowfullyoperational

2012ClianthaResearchLimited

OurServices

ClianthaTrials

BA/BEStudies

Dermatology

Personal Healthcare

Biometrics

Central ReferenceLab

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ClianthaTrials
Infrastructuresetuptoconductglobal PhaseIIVtrials 1500+GCPtrainedvalidatedqualityinvestigator sitesinUSA,EUandIndia Therapeuticareas:Oncology/Hematology, Dermatology,Psychiatry,Cardiology, Diabetology,Ophthalmologyand Gastroenterology Combinedteamexperienceofmorethan 50yearsinclinicaltrials Formoredetailslogonto: www.clianthatrials.com
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Expertisein:
Globalfeasibilitystudies Projectmanagement Sitemanagementandrisk basedmonitoring Regulatoryaffairs Supplymanagement Centrallabservices

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BA/BEStudies
Conductedover1500studies 9clinicalunits,400beds,12ICUbedsand 20doctors CentralLabaccreditedbyCAP 55,000healthysubjectsdatabase Infrastructureincludesfreezers,cardiac monitors,securedpharmacy,controlled archives,andpowerbackup

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Bioanalytical
LabsinIndiaandMexicoCity Over180analyticalmethodsinbiological fluids 21LC/MS/MS(API3000,4000,5500) ICPOESforelementalanalysis Over1.5millionsamplesanalyzed

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Dermatology
ClianthaResearchacquiredHillTopResearch, whichspecializesinmanagingPhaseIIV clinicaltrialswithfocusonDermatology Opportunitytoexecutestudiesinmultiple locationswithmultipleclimaticconditionsin N.Americaand/orIndia EstablishedGlobalInterscorervariability
Expertisein:
Transdermal/Topical Bioequivalence ContactSensitization HumanRepeatInsultPatch Test(HRIPT) CumulativeIrritation(14 and21daystudies) Wearstudies SkinBlanching (Vasoconstrictionstudies)

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PersonalHealthcare
HillTopResearch,withover65yearsexperience inPersonalHealthcareindustry Twolocationswithdifferentclimaticconditions andpatientpool SafetystudiesforOTC,cosmeticandpersonal healthcareproducts

Expertisein:
Phototoxicity Photoallergy Comedogencity Skincare antiaging, moisturizers,skinofcolor Antiperspirantsand deodorants PersonalHygieneproducts Babycareproducts Femininecareproducts Cosmeticproducts

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Biometrics
Fullservice CDM,PharmacokineticsandStatistics InfrastructurebasedinIndia eCRFandpaperCRF SASPheedIT Libraries MedDRA,WHODD WinNonlin Pharmacokineticanalysis SAS Statisticalanalysis Reports FDA,ICHE3,TPD,TGAformats

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CentralReferenceLab
CAPaccreditedlabwithstateoftheartfacilities formulticentricClinicalTrials Completerangeofspecializedtestswitha test menucoveringHematology,Coagulation, Clinicalchemistry,Immunology,Serology,Clinical Pathology,FlowCytometry CombinesinnovativeR&Dcapabilitiesfor developingandvalidating ligandbindingassays formacromoleculesforPKandimmunogenicity studies CapabilitiestodevelopandvalidateanAssayto meetspecificneedsofaprotocol

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QualityAssurance(QA)
QAteamindependentlymonitorsallactivitiesensuringcompliancetoProtocol, SOPs,GCP,GLPandotherregulations:

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Projectflow

Set-up weekly calls for regular study updates

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TypicalTimelinechart
Day 07 814 1521 2228 2935 3642 4349 5056

(Assumptions: No. of subject: 36, No. of periods: 2,Washout period: 7 days; Delivery in < 120 days)
5763

Week
Project Confirmation Protocol finalization EC&BENOC/T License MD/MV (ifapplicable)

W1

W2

W3

W4

W5

W6

W7

W8

W9

Day

64-70

71-77

78-84

85-91

92-98

99-105

106 -113

114-120

Week
IPTransfer ClinicalPhase completion Bioanalysis PK/Statistics Draftreport Finalreport

W10

W11

W12

W13

W14

W15

W16

W17

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Casestudy
FlawlessfastestANDA FirsttoFilesubmission:
CompletedUSFDAbiosubmission studywithinaweek Meticulouscoordinationbetween therespectiveteamsenabledto accomplishperfectstudyanddeliver thedatawithoutcompromisingany ethicalstandards Clinicstarts Clinicends Bioanalysis starts Bioanalysis ends Milestones FastingBE Study(n=36) 04Apr2012 08Apr2012 08Apr2012 10Apr2012 FedBEstudy (n=36) 05Apr2012 09Apr2012 09Apr2012 10Apr2012 10Apr2012

Finalreport 10Apr2012

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Team
VijayPatel
ExecutiveDirector 21yearsManagementexperience

RahulNijhawan
AssociateDirector,GlobalProjectManagement 12yearsResearchexperience

NaveenSharma
ChiefOperatingOfficer 17yearsResearchexperience

ArpanaPrasad
AssociateDirector,Bioanalyticallab 15yearsBioanalyticalexperience

Dr.RobertA.Harper
President 25yearsDermatologyexperience

AnshulDogra
AssociateDirector,Bioanalyticallab 12yearsBioanalyticalexperience

Dr.CharuGautam
Director,GlobalClinicalOperations 13yearsClinicalexperience

Dr.ShaifaliGupta
Head,CentralReferencelab 11yearsPathologyexperience

AnitaKaul
VicePresident,GlobalQualityAssurance 20yearsQAexperience

Dr.SimranSethi
GeneralManager,MedicalAffairs 13yearsofResearchexperience

HiteshChauhan
AssociateDirector,Biometrics 12yearsofStatistics&CDMexperience
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OurAssets

Clianthateam
700 andgrowingincluding20doctors Combinedexperienceofover50yearsatleadingpharmacosandCROs

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ThankYou
www.cliantha.in

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