Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing

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This report offers the pharmaceutical and biotech industry, and its service providers “peer-based” guidance on the adoption, use, and outsourcing of risk-based monitoring.

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Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing

  1. 1. Risk-based Monitoring:Industry Guidance onAdoption, Use, andOutsourcingInfo@ISRreports.com ©2013 Industry Standard Research www.ISRreports.comPREVIEW
  2. 2. www.ISRreports.com ©2013 | Preview of: Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing 22act with confidenceReport OverviewThis report offers the pharmaceutical and biotech industry, and its service providers “peer-based” guidance onthe adoption, use, and outsourcing of risk-based monitoring.145pages78respondents83charts and graphs1. Executive Summary2. Risk-based Monitoring (RBM) Awareness and Definition3. Best Practices & Operational Impact of RBM4. Sponsor Perception and Use of RBM5. Data and Technology6. Outsourcing Environment7. RBM Economics8. Respondent DemographicsMajor Sections:What you will learn in this report:• Sponsors’ interests in and use of RBM studies, why RBM is gaining momentum, what is drivingadoption, and a high-level look at sponsors’ expected financial and operational outcomes of RBMstudies• Real-world lessons-learned, including advice for individuals and companies wanting to implementRBM studies• Study types that are seen as most appropriate for RBM and which departments are involved in theplanning of these studies• On-the-ground suggestions for improving the RBM regulatory and training processes• Which technologies are most important to running a successful RBM-based trial and which aremost difficult to implement• The percentage of RBM studies outsourced, the preferred types of service providers, and mostimportant service provider attributes impacting selectionHow you can use this report:For sponsors: Use this information to help drive RBM adoption in your organization, avoid pitfalls thatmight stagger RBM growth, inform your data infrastructure strategies, and benchmark the use of RBM.For service providers: Better understand the inner working of sponsors as it relates to the adoption ofRBM models and craft better messages and service offerings to account for these views.Valuable for:Clinical Operations, Medical Directors, R&D Management, Therapeutic Heads, Clinical Service Providers
  3. 3. www.ISRreports.com ©2013 | Preview of: Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing 33act with confidenceTable of Contents (1 of 2)Full table of contents, additional sample pages, and ordering infor-mation are available in the full preview at:http://isrreports.com/industry-reports/riskbased-monitoring-in-dustry-guidance-on-adoption-use-and-outsourcing
  4. 4. www.ISRreports.com ©2013 | Preview of: Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing 44act with confidenceSample Page: Report Introductionact with confidencewww.ISRreports.com ©2013 | 2013 CRO Quality Benchmarking – Phase II/III Service Providers 2CovanceICONINC ResearchPAREXELPharmaNet/i3PPDPRAQuintilesBioclinicaDCRI-DukeMedpacePremier ResearchRPSSGS Life SciencesWorld WideClinical TrialsMinimizingStaffTurnoverCRA QualityProject TeamChemistryTherapeuticExpertiseTimely ProjectCommunicationsCommercialMarketKnowledgeProjectManagerQualityStaff CharacteristicsRatings Key: Clear leadership Better than most About average Falling a bit shortLocal Market /RegulatoryKnowledgeFigure 1 – “Staff Characteristics” RatingsResponses have beenrandomized. Data available inthe full report.© 2013 Industry Standard ResearchWhat’s in a name?Well, if you ask marketing and branding experts, they will tell you a name can be everything. At ISR, wehave found it interesting that someone in the pharmaceutical industry named a process for monitoringinvestigative sites and patient data “risk-based monitoring.” For an industry that is notoriously risk-averseand highly regulated, we would have bet against a solution named “risk-based monitoring” gainingtraction. But it has.ISR believes the rise of risk-based monitoring (RBM) is a result of several forces acting on thepharmaceutical industry. First, while it has taken what seems like an eternity, electronic data capture(EDC) technology is now the de facto standard for site/ patient data capture. Second, the patent cliffand declining R&D productivity rates have conspired to “force” pharmaceutical companies to look atways to cut costs, while increasing efficiency. This has led companies to ask whether 100% sourcedocument verification (SDV) is really necessary and whether dispatching throngs of medical monitorshas a corresponding positive impact on data quality. Third, regulators have begun to output guidancedocuments that center on alternative drug development models and processes (risk-based monitoring,adaptive trials, electronic data as source data), making it less risky for sponsors to employ thesemethodologies/ strategies.What we learned from the data in this report is that RBM is a process. The awareness of and interest inRBM is relatively high. Sponsors are, or should be, doing their due diligence on the topic. They are lookingfor both internal subject matter experts across many different disciplines within their organization and forCROs who have experience in not only operationally executing RBM studies, but for CROs who can/ willinput on the design and strategies surrounding them.At this point in the life cycle of RBM, planning is king.
  5. 5. www.ISRreports.com ©2013 | Preview of: Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing 55act with confidenceSample Pagesact with confidence3%  6%  38%  44%  9%  0%   15%   30%   45%   60%  Strongly  disagree  Disagree  Neither  agree  or  disagree  Agree  Strongly  agree  Cost-benefit of risk-based monitoring“Using the agree/disagree scale below, please indicate your agreement with thefollowing statement: The overall benefits of risk-based monitoring outweigh the timeand resources needed upfront to gain regulatory approval of the protocol and risk-based monitoring plan/strategy?”(Base = 78)© 2013 Industry Standard Research© 2013 Industry Standard Research
  6. 6. www.ISRreports.com ©2013 | Preview of: Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing 66act with confidenceSample Pageact with confidence− www.isrreports.com  ©2013|  Risk-­‐based  Monitoring  Market  Assessment      135  37%  23%  20%  41%  43%  36%  0%   20%   40%   60%   80%   100%  No  RBM  experience  (N=9)  RBM-­‐experienced  (N=69)  High  risk;  required  more  verificaRon/  review  Medium  risk;  requires  moderate  verificaRon/  review  Low  risk;  requires  less/  no  verificaRon/  review  26%  29%  36%  41%  38%  30%  0%   20%   40%   60%   80%   100%  No  RBM  experience  (N=9)  RBM-­‐experienced  (N=69)  High  risk;  required  more  verificaRon/  review  Medium  risk;  requires  moderate  verificaRon/  review  Low  risk;  requires  less/  no  verificaRon/  review  Investigative sites: risk-level assessment“What percent of your investigative sites fall under the following three levels of risk?”Clinical studies: risk-level assessment“What percent of your studies fall under the following three levels of risk?”© 2013 Industry Standard Research© 2013 Industry Standard Research
  7. 7. www.ISRreports.com ©2013 | Preview of: Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing 77act with confidenceOrdering InformationIndustry Standard Research (ISR) is the premier, full service market research provider to the pharma andpharma services industries.  With over a decade of experience in the industry, ISR delivers an unmatchedlevel of domain expertise.  For more information about our off-the-shelf intelligence and custom research offerings, please visit ourWeb site at www.ISRreports.com, email info@ISRreports.com, or follow us on twitter @ISRreports.About Industry Standard ResearchOrdering Information, full table of contents, and additional samplepages are available in the full preview at:http://isrreports.com/industry-reports/riskbased-monitoring-in-dustry-guidance-on-adoption-use-and-outsourcing

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