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Key Attributes while Selecting CRO for your Research Trials

Major criteria for CRO selection:<br>- Structure and financial stability<br>- Scientific capabilities<br>- Quality Assurance audit/review

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Key Attributes while Selecting CRO for your Research Trials

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  1. Challenges in the CRO Industry: Selecting a CRO for your Research Trials © 2017-2018 All Rights Reserved, No part of this document should be modified/used without priorconsent PEPGRA Healthcare PvtLtd INDIA: Nungambakkam, Chennai, 600034. UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com,Web:www.Pepgra.com.

  2. ChallengesintheCROIndustry:SelectingaCROforyourResearchTrialsChallengesintheCROIndustry:SelectingaCROforyourResearchTrials ClinicalResearchOrganizationforHealthcareprovidesclinical-studyandclinical-trial supportfordrugsandmedicaldevices,whereinmanypharmaceuticals,biotechnology, andmedicaldeviceindustrieshavingoperationsintheEuropeUnionstatesoutsource researchservicestoCROtoincreaseefficiencyandimproveproductivity. Contract Research Organization for Pharmaceutical Industryoffer services such as Project,DataandRegulatoryManagement;Contracting;MedicalWriting;andSiteand Medical Monitoring, which offers the comprehensive benefits for pharmaceutical companiesinEuropeUniontomakeclinicalresearchtrialsmoreefficientand cost-effectiveintestingeconomicperiod. © 2017-2018 All Rights Reserved, No part of this document should be modified/used without priorconsent PEPGRA Healthcare PvtLtd INDIA: Nungambakkam, Chennai, 600034. UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com,Web:www.Pepgra.com.

  3. ChallengesintheCROIndustry:SelectingaCROforyourResearchTrialsChallengesintheCROIndustry:SelectingaCROforyourResearchTrials • CRO industryChallenges • TheCROfacesmultifacetedchallengesintheformof • Increasinglybecomingcomplexnatureofregulatoryrequirements,GxP compliance, andquality. • HighlevelsofriskassociatedwiththeCRObusinessmodel • Increasingcostofresearchtrials • Inabilityof CRO’stoabsorbhighlevelsofrisk • Fragmentednatureofbusinessandcontinuoustrendtowardsconsolidation • Variablenatureofqualityinthebusinessthatisinfluencedbymanyfactors • Requirement of resource-intensivemanagement • Decreasedcostsavingsandprofitability. • Researchpersonnelchangesandlosingknowledgeableteammembersduring mergers andreorganizations • Global/localCompetitionintermsofpricevariation • KeyattributesinselectingaCROforaresearchtrial • SponsoringPharmaceuticalandMedicaldevicecompaniesgenerallyfocusonimportant attributes like confidentiality, quality, cGMP compliance, timeliness, project cost, the reputation of CRO while choosing their outsourcing partner for conducting research trials. • ThemajorcriteriaforCROselectioncaninclude CROstructure and financial stability Factorssuchascompanyreputation,structureandtheirfinancialconditionandtheir2 years past record performance are all good indicators to look out for in a CRO while outsourcing clinicaltrials Scientific capabilities andEfficiencies PharmaceuticalcompaniescanoutsourceresearchtrialstoCROafterdoingadetailed investigation on their complex skills and specialized competencies in the particular researchtrialareathatisnotavailablein-house. © 2017-2018 All Rights Reserved, No part of this document should be modified/used without priorconsent PEPGRA Healthcare PvtLtd INDIA: Nungambakkam, Chennai, 600034. UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com,Web:www.Pepgra.com.

  4. ChallengesintheCROIndustry:SelectingaCROforyourResearchTrialsChallengesintheCROIndustry:SelectingaCROforyourResearchTrials Serviceportfolio Medical Devices manufacturers and Pharmaceutical companies need to choose a quality-driven global Clinical Research Organization (CRO) possessing excellent therapeutic area expertise and experienced scientific and medical writers capable of producinghigh-qualityClinicalResearch writing forhealthcare.TheCROneedstooffer an array of services such as scientific medical writing, physician writing, publication support, biostatistics, and regulatory writing as per the European Union state requirements. TheMedicaldevicecompaniesneedtochooseCROthathasgoodcapabilitytoproduce quality-rich Regulatory writing for class iii Medical Devicesessential for getting Premarketapproval(PMA)andhasextensiveexperienceinpreparingClinicalEvaluation Reports(CER), CE-market studies, post-market studiesetc. Quality Assuranceaudit/review Quality Assurance (QA) plays a critical role throughout the sponsor company- CRO outsourcingpartnership,whichhelpsthehealthcare,pharmaceuticalandmedicaldevice companies sponsoring the research to ensure complete compliance with the Europe Union State-specific applicableGxP requirements. Thus, the pharmaceutical and medical device companies need to look out for these criticalelementswhileselectingasuitableCROfortheirresearchtrials,whichcanhavea significantimpactontherealizationoftheirbusinessgoalsandobjectives. AboutAuthor, Dr. Nancy, Editor-in-chief, PEPGRA HealthcarePvtLtd. © 2017-2018 All Rights Reserved, No part of this document should be modified/used without priorconsent PEPGRA Healthcare PvtLtd INDIA: Nungambakkam, Chennai, 600034. UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com,Web:www.Pepgra.com.

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