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EXECUTIVESUMMARY

JavaClinicalResearchLtdisanIrishClinicalResearchOrganisation(CRO)locatedinDublinandaffiliatedwithtwoof Irelandslargestmedicaluniversities,UniversityCollegeDublin(UCD)andTheRoyalCollegeofSurgeonsinIreland (RCSI).Javaprovidesacompleteclinicaltrialservicestothepharmaceutical,biotechnologyandmedicaldevice industries. Over the past few years, Java has recognised the clinical trial support needs of both established and emerging,indigenousstartupmedicaldevicecompaniesandnowprovidesexpertadvicebothinthedevelopment, planningandmonitoringstagesoftheirclinicalinvestigationalprogrammes.Javaissupportedbyexcellent laboratoryservicesanduniquetechnologyplatforms.

COMPREHENSIVERANGEOFSERVICES
OURSERVICESINCLUDE: ProjectManagement ClinicalMonitoring CompetentAuthoritySubmissions EthicsCommitteeApplications ICHGCPtrainingtoCRAsandSitePersonnel Expertfinancialandtaskmilestoneconsultancyadvice

StudyProtocolandCRFDesign GCPSOPwriting InvestigationalSiteAudits ScientificConsultancy

THERAPEUTICAREAEXPERTISE

Overthepast10years,Javasskilledresearchteamhavedevelopedsignificantexperienceinconductingclinical researchtrialsthatspanacrosstheentiredevelopmentspectrum,rangingfromtheinitialstudiesinPhaseIthrough topostmarketingsurveillancetrialsinPhaseIV,andincludesthefollowingkeytherapeuticareas: Oncology Cardiology Gastroenterology RespiratoryMedicine Analgesia Rheumatology Neurology MetabolicDiseases Gerontology Surgery

TOWARDSTHENEXTGENERATIONOFCLINICALTRIALS
OuraffiliationwithUCDandRCSI,andourestablishedrelationshipwithInvestigatorswhohaveparticipatedin previousJavastudies,givesusdirectaccesstoalargeinvestigatornetworkandlargepatientdatabases.These investigatorsareexperiencedresearchprofessionalwithhighlytrainedstaffandexcellentfacilities.Inaddition,since theIrishGovernmentsStrategyforScience,TechnologyandInnovation20062013recognisedtheneedtoupgrade existinginfrastructureanddevelopnewfacilitiestosupportresearchJavahasbenefitedfromoperatingina dynamicclinicalresearchenvironment.Overthepastfewyears,significantinvestmenttowardstheestablishmentof aworldclassresearchinfrastructurehasincludedthecreationofClinicalResearchCentres(CRCs)inthemainIrish teachinghospitals.JavaworkscloselywithresearchersintheCRCsandassociatedhospitalsanduniversitieswhoare engagedinnoveltranslationalandbiomedicalengineeringresearchinareasincludingvascularbiology,respiratory medicine,infectionandimmunity,metabolicdiseases,neuropsychiatryanddermatology.Workingwithboth physicians,scientists,engineersandthebiosciencesindustry,wekeepabreastwiththewiththelatestandbest technologiesinIreland. Thesehighqualityresourcesenableustocarryoutquickfeasibilityassessmentsandwillallowustoprovidesponsor companiesonadviceonrealistictimelinesandthemilestonesachievablefortheirproject. AGATEWAYTOEUROPE

WehaveformalisedallianceswithnetworksofEuropeanCROscomprisingofcompaniessimilarinsizetoJava.These allianceshaveprovenverysuccessfulforJavasclientswhowishtorunpanEuropeanprojects.Throughsuch networksJavaaretrulyagatewaytoEurope,providingmaximumflexibilityandoptimal,costeffective,trial managementatlocallevel.

Fromdeterminingwhereandhowtostartyourclinicaltrial,toidentifyingthemostinfluentialKeyOpinion LeadersacrossEurope,Javasexpertisewillhelpyourunthemostefficientandcosteffectivestudypossible.

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