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BioM-ForumWie finde ich die richtige CRO?

Norman G. Neville, MD06 Mai 2008

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Outline

Why outsource to a CRO?How many CROs should I evaluate? Where is the CRO industry headed?What exactly does the project require?How to recognize the ideal CRO? When to begin search?How to standardize? What kind of financial arrangement?Best practices

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Why outsource to a CRO?

Can reduce the time required to develop and bring a new drug to market Sponsor can convert the fixed costs of maintaining the personnel, expertise and facilities like data management necessary for clinical trial management into variable costs Non-availability of services in-house Knowledge of regulatory affairs in a particular country of interest Increased complexity of clinical trials Increased amount of data required from clinical trials Multinational and multi-center nature of current clinical trials Large requirement of patient populations Regionalized diseases

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How many CROs should I evaluate? (“Short” list)North & South AmericaAdvanced Clinical ResearchAlgorithme PharmaAllied Clinical ResearchAlquest, Inc.Amarex Clinical ResearchAnapharmArkios BioDevelopment InternationalARS, Inc.Atlantic Life Sciences Inc.Averion Inc.BioClin Health ResearchBiovail Contract ResearchBRI Biopharmaceutical Research Inc.Carolinas Research AssociatesCato ResearchCCS Associates, Inc.Cellular Technology Ltd.Center for Health Services ResearchA CentraLabS Clinical ResearchChiltern InternationalCirion Biopharma ResearchClinical Assistance ProgramsClinical Research Consulting, Inc.Clinical Supplies Management Inc.Clinimetrics Research AssociatesClinStat, Inc.CovanceCPIC Latin AmericaC.R.O.Cont(r)actsCroMedica Group of Medicines Development

CompaniesCTO Clinical Trial Operations b.v. NetherlandsDermTech InternationalEmissary, Inc.GENTIAE Clinical ResearchGrayline Clinical Drug TrialsGulf Coast Research Associates, Inc.ICON Clinical ResearchINC ResearchInfoQuestIngenix Pharmaceutical ServicesInternational Drug Development Institute

(IDDI)Inveresk Research International, Ltd.KAI

Kriger Research Group InternationalKriger Research Center IncMarshall-BlumMAT & ASOC.Millenix, Inc.Moncoa Medical Research Inc.MonitorForHire.comNCGS Laboratories, Inc.NeuromorphometricsNew Brunswick ScientificNew Drug ServicesNorthwest KineticsNorwich Clinical Research Associates LtdNovum Pharmaceutical Research ServicesOmnicare Clinical ResearchOperatrix Consulting Inc.P3 Research, Ltd.PeachTree Clinical Research, LLC.Pharmaceutical Consultants, Inc.PharmaLinkFHIPharmatek Laboratories, Inc.Piedmont Consulting Group, LLCPinnacle Research Group, LLCPremier ResearchPrevalere Life Sciences, Inc.Quantum Clinical ResearchQuintiles Transnational Corp.Research & Development RA SAResearch Dynamics Consulting Group, Ltd.Scian Research ServicesScirex CorporationSFBC InternationalSMO-USA, Inc.Southern Clinical & Regulatory, Inc.Stone ConsultoresSymbion Research InternationalSynergos, Inc.Synteract, Inc.Target Health Inc.TERRE Clinical Research Services, Inc.TherImmune Research CorporationTKL Research, Inc.Trial Management Group, Inc.TrialStar, Inc.ViroMed LaboratoriesVPDC, Inc.Washington Biotechnology, Inc.

EuropeASCOpharmAster CephacBiodata Services ApSBio-Kinetic Europe, Ltd.BiotrialC &T ParadigmCEPHA s.r.o.ClinResearch, GmbHClintriaClinTrial LtdCognatec Research CentreCORONIS Research SACTO Clinical Trial Operationsd-TargetDW Coordinating CenterEpiStat Group, Inc.EuphamedFOCUS Clinical Drug DevelopmentFOVEA GroupHungaroTrialIFE Baltic, UABImro Tramarko Contract Research OrganisationIndependent Clinical Research Consulting (ICRC)Independent Research and Laboratory Solutions (ILS SA)Institut fuer Klinische Pharmokologie GmbH (IKP)Intercern Clinical ResearchIST GmbHK.A. Seldeslagh & Associates (Kasa)Kriger Research Center Inc Meddoc ApSMedical Statistics ConsultancyMedico Chemical LabMedicon A/SMonipolNorthWise ServicesNottingham Clinical Research GroupPFC Pharma FocusPharm PlanNetPharmalog - Institute for Clinical ResearchPharmaPart AGPhase 1 CTU Ltd.PhaVistaPSI Pharma Support IncRadwan Clinical Research Center

Remedium Clinical ResearchRotrimenRussian Clinical TrialsScope InternationalSedoc Pharmaceutical Medicine ABSiteSupportSpadille ApSSquarepoint-PointcarréSwiss Pharma ContractSynexus, Ltd.TNO BIBRA International Ltd.UniMRUrodoc Limited VALID-TRIO GmbH

AsiaAPEX International Clinical Research Co., Ltd.Asian Clinical TrialsCatalyst Clinical ServicesGleneagles CRCKansai Research InstituteKriger Research Center Inc Metrics ResearchMonitor Medical Research and Consulting Protech Pharmaservices Corporation (PPC)Siro ClinPharm Pvt LtdSynchron Research Services Pvt. Ltd.

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Where is the CRO industry headed?

2005 pharmaceutical and biotechnology R & D expenditures57 billion USD!14 billion USD of which on CROs

Outlays will increase further as CROs broadening services

Over 1,200 organizations involved in clinical researchpharmaceutical and biotechnology in-house clinical researchsite management organizations (SMOs)academic medical centersprivate research sitescontract research organizations (CROs)

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Define scope of work: Full service vs selective tasksMore than one CRO for a projectEvery conceivable service is offered

What exactly does the project require?

Project managementRegulatory affairsPharmacovigilanceCardiac safetyData managementCRF designBiostatisticsSite managementStudy logistics, drug supply, IVRS

Core/central lab (imaging, pathology, etc)SAPQuality AssuranceProduct DevelopmentMedical WritingManufacturingGxP complianceCommercialization

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Professional, motivated, dedicated and focused staff with thorough, up-to-date training

SOPs, training logs, internal vs external training opportunitiesProject reporting tools, eg, internet portal, spread sheets, prompt meeting minutes

Low attrition, stable staff, project team member longevityExpertise in target indication: in house vs external consultantsLarge database/network of vetted investigative sitesTestimonials: customer (sponsor), investigator site commentsAudit reports; inspection outcomes

How to recognize the ideal CRO? (1)

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Study start-up times Recruitment speed: actual vs projected; on target vs overtimePatient/site ratioData integrity/query resolutionNumber of indications, patients, trials, sites, countries (where, and since when)Sponsors: big pharma vs biotechDirect presence vs partner CROs, eg, Russia, IndiaDrugs brought to market; success in phase 1-3

How to recognize the ideal CRO? (2)

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Demonstrated leadership in industry organisationsSponsor awards (best recruiting CRO)Composition of Scientific Advisory Committee/Board MembersProfessional certifications (lab professionals)Membership in professional organisations:

Association of Clinical Research Organizations (ACRO) Association of Clinical Research Professionals (ACRA)Society of Clinical Research Associates (SoCRA)DIA

How to recognize the ideal CRO? (3)

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Start early: process can take 6 months or more to conduct a successful CRO search, evaluation and contract finalization

CROs need time to do a thorough evaluation of project, patient recruitment potential, internal and external costsSponsors need time to evaluate all bids and schedule bid defensesFinal contract ready much later than anyone predicted

Understand your project needsdefine precisely roles and expectationsdo a targeted search of CROs based on project specs

Mature protocol/synopsis/project plan, etc. is key to successful search

When to begin search?

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Request for proposal (RFP) is a mustInvitation for suppliers/CRO via a bidding process to submit a proposal for a specific serviceBrings structure to the procurement/bidding processAllows identification of risks and benefitsMore than a request for priceInformation may include:

basic corporate and financial informationtechnical capabilitiesestimated completion datesdetailed project specificationscost break-down of component services

How to standardize? (1)

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Request for ProposalInsist on use of sponsor RFP templateSponsor-defined spec sheet yields better cross-bid comparabilityObtain at least 4 bids from CROsFace to face bid defense for runners-up

Checklists can focus scrutiny and insure completeness

How to standardize? (2)

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Low up front payment, eg, Letter of Intent (LOI)minimizes financial exposure at early project stage

Incentivization and milestone based payment scheduleShould be anticipatory, complete and comprehensive at start of projectShould insure low likelihood of Change(s) of Scope due to insufficient planning

Major reason for sponsor dissatisfaction Define liability in event of project delay, failure (risk sharing)Feasibility analysis “free” in the event of award

What kind of financial arrangement?

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Start search and evaluation earlyPrepare solid project plan/study outline to guide needs reviewBigger is not necessarily better: smaller CROs may have more flexibilityWhere feasible perform pre-selection auditObtain testimonials; ask colleagues for experienceUse standardized RFP to obtain inter-bid comparibilityRisk-sharing contracts

Best practices

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THANK YOU