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Major criteria for CRO selection:\n- Structure and financial stability\n- Scientific capabilities\n- Quality Assurance audit/review

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challenges in the cro industry selecting

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.

challenges in the cro industry selecting 1

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.

challenges in the cro industry selecting 2

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.

challenges in the cro industry selecting 3

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.