BioM-Forum Wie finde ich die richtige CRO? Norman G. Neville, MD 06 Mai 2008
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
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
How many CROs should I evaluate? (“Short” list) North & South America Advanced Clinical Research Algorithme Pharma Allied Clinical Research Alquest, Inc. Amarex Clinical Research Anapharm Arkios BioDevelopment International ARS, Inc. Atlantic Life Sciences Inc. Averion Inc. BioClin Health Research Biovail Contract Research BRI Biopharmaceutical Research Inc. Carolinas Research Associates Cato Research CCS Associates, Inc. Cellular Technology Ltd. Center for Health Services Research A CentraLabS Clinical Research Chiltern International Cirion Biopharma Research Clinical Assistance Programs Clinical Research Consulting, Inc. Clinical Supplies Management Inc. Clinimetrics Research Associates ClinStat, Inc. Covance CPIC Latin America C.R.O.Cont(r)acts CroMedica Group of Medicines Development Companies CTO Clinical Trial Operations b.v. Netherlands DermTech International Emissary, Inc. GENTIAE Clinical Research Grayline Clinical Drug Trials Gulf Coast Research Associates, Inc. ICON Clinical Research INC Research InfoQuest Ingenix Pharmaceutical Services International Drug Development Institute (IDDI) Inveresk Research International, Ltd. KAI
Kriger Research Group International Kriger Research Center Inc Marshall-Blum MAT & ASOC. Millenix, Inc. Moncoa Medical Research Inc. MonitorForHire.com NCGS Laboratories, Inc. Neuromorphometrics New Brunswick Scientific New Drug Services Northwest Kinetics Norwich Clinical Research Associates Ltd Novum Pharmaceutical Research Services Omnicare Clinical Research Operatrix Consulting Inc. P3 Research, Ltd. PeachTree Clinical Research, LLC. Pharmaceutical Consultants, Inc. PharmaLinkFHI Pharmatek Laboratories, Inc. Piedmont Consulting Group, LLC Pinnacle Research Group, LLC Premier Research Prevalere Life Sciences, Inc. Quantum Clinical Research Quintiles Transnational Corp. Research & Development RA SA Research Dynamics Consulting Group, Ltd. Scian Research Services Scirex Corporation SFBC International SMO-USA, Inc. Southern Clinical & Regulatory, Inc. Stone Consultores Symbion Research International Synergos, Inc. Synteract, Inc. Target Health Inc. TERRE Clinical Research Services, Inc. TherImmune Research Corporation TKL Research, Inc. Trial Management Group, Inc. TrialStar, Inc. ViroMed Laboratories VPDC, Inc. Washington Biotechnology, Inc.
Europe Remedium Clinical Research ASCOpharm Rotrimen Aster Cephac Russian Clinical Trials Biodata Services ApS Scope International Bio-Kinetic Europe, Ltd. Sedoc Pharmaceutical Biotrial Medicine AB C &T Paradigm SiteSupport CEPHA s.r.o. Spadille ApS ClinResearch, GmbH Squarepoint-Pointcarré Clintria Swiss Pharma Contract ClinTrial Ltd Synexus, Ltd. Cognatec Research Centre TNO BIBRA International Ltd. CORONIS Research SA UniMR CTO Clinical Trial Operations Urodoc Limited d-Target VALID-TRIO GmbH DW Coordinating Center EpiStat Group, Inc. Euphamed FOCUS Clinical Drug Development FOVEA Group HungaroTrial IFE Baltic, UAB Imro Tramarko Contract Research Organisation Independent Clinical Research Consulting (ICRC) Independent Research and Laboratory Solutions (ILS SA) Institut fuer Klinische Pharmokologie GmbH (IKP) Intercern Clinical Research Asia IST GmbH APEX International Clinical Research Co., K.A. Seldeslagh & Associates (Kasa) Ltd. Kriger Research Center Inc Asian Clinical Trials Meddoc ApS Catalyst Clinical Services Medical Statistics Consultancy Gleneagles CRC Medico Chemical Lab Kansai Research Institute Medicon A/S Kriger Research Center Inc Monipol Metrics Research NorthWise Services Monitor Medical Research and Consulting Nottingham Clinical Research Group Protech Pharmaservices Corporation PFC Pharma Focus (PPC) Pharm PlanNet Siro ClinPharm Pvt Ltd Pharmalog - Institute for Clinical Research Synchron Research Services Pvt. Ltd. PharmaPart AG Phase 1 CTU Ltd. PhaVista PSI Pharma Support Inc Radwan Clinical Research Center
Where is the CRO industry headed?
2005 pharmaceutical and biotechnology R & D expenditures 57 billion USD! 14 billion USD of which on CROs Outlays will increase further as CROs broadening services Over 1,200 organizations involved in clinical research pharmaceutical and biotechnology in-house clinical research site management organizations (SMOs) academic medical centers private research sites contract research organizations (CROs)
What exactly does the project require?
Define scope of work: Full service vs selective tasks More than one CRO for a project Every conceivable service is offered
Project management Regulatory affairs Pharmacovigilance Cardiac safety Data management CRF design Biostatistics Site management Study logistics, drug supply, IVRS
Core/central lab (imaging, pathology, etc) SAP Quality Assurance Product Development Medical Writing Manufacturing GxP compliance Commercialization
How to recognize the ideal CRO? (1) Professional, motivated, dedicated and focused staff with thorough, up-todate training SOPs, training logs, internal vs external training opportunities Project reporting tools, eg, internet portal, spread sheets, prompt meeting minutes
Low attrition, stable staff, project team member longevity Expertise in target indication: in house vs external consultants Large database/network of vetted investigative sites Testimonials: customer (sponsor), investigator site comments Audit reports; inspection outcomes
How to recognize the ideal CRO? (2)
Study start-up times Recruitment speed: actual vs projected; on target vs overtime Patient/site ratio Data integrity/query resolution Number of indications, patients, trials, sites, countries (where, and since when) Sponsors: big pharma vs biotech Direct presence vs partner CROs, eg, Russia, India Drugs brought to market; success in phase 1-3
How to recognize the ideal CRO? (3)
Demonstrated leadership in industry organisations Sponsor awards (best recruiting CRO) Composition of Scientific Advisory Committee/Board Members Professional 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
When to begin search?
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 costs Sponsors need time to evaluate all bids and schedule bid defenses Final contract ready much later than anyone predicted Understand your project needs define precisely roles and expectations do a targeted search of CROs based on project specs Mature protocol/synopsis/project plan, etc. is key to successful search
How to standardize? (1) Request for proposal (RFP) is a must Invitation for suppliers/CRO via a bidding process to submit a proposal for a specific service Brings structure to the procurement/bidding process Allows identification of risks and benefits More than a request for price Information may include: basic corporate and financial information technical capabilities estimated completion dates detailed project specifications cost break-down of component services
How to standardize? (2)
Request for Proposal Insist on use of sponsor RFP template Sponsor-defined spec sheet yields better cross-bid comparability Obtain at least 4 bids from CROs Face to face bid defense for runners-up Checklists can focus scrutiny and insure completeness
What kind of financial arrangement?
Low up front payment, eg, Letter of Intent (LOI) minimizes financial exposure at early project stage Incentivization and milestone based payment schedule Should be anticipatory, complete and comprehensive at start of project Should 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 â€œfreeâ€? in the event of award
Start search and evaluation early Prepare solid project plan/study outline to guide needs review Bigger is not necessarily better: smaller CROs may have more flexibility Where feasible perform pre-selection audit Obtain testimonials; ask colleagues for experience Use standardized RFP to obtain inter-bid comparibility Risk-sharing contracts
Why outsource to a CRO? Where is the CRO industry headed? When to begin search? How to recognize the ideal CRO? How to standardize? What kin...