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Inc Reducing Risk Wp

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  • 1. Reducing Risk with the Right CRO Partner Evaluating CROs with Confidence Therapeutic Foresight. Trusted Results. SM
  • 2. Page 2 Reducing Risk with the Right CRO Partner Evaluating CROs with Confidence For drug developers, finding the right patients, investigators and outsourcing partners is essential. With shareholders demanding improved efficiencies, the resources, reach and expertise of a contract research organization (CRO) can expedite the research and development process. The long-term CRO relationship often travels a rocky path fraught with challenges. While poor communication and inefficiencies are common pitfalls, the fear of change is often too daunting. Many organizations simply remain uncomfortably restrained to the status quo. To make matters worse, there is no CRO Consumer Reports guide for organizations desiring change. How can key decision makers objectively evaluate their CRO partner relationships? What can be done to increase a trial's success? To meet these challenges, many sponsors are soliciting the services of CROs that employ process-driven clinical research methods. Designed to help achieve more predictable costs and actionable results, CROs employing these methods are speeding the research and development process, while reducing trial risks. This white paper will examine key challenges faced by drug developers and reveal the many advantages of process-driven clinical research. Challenges Deterring Clinical Operations Excellence Despite the Food and Drug Administration’s (FDA) efforts to improve its review and Longer clinical trials and approval of new drugs, trials are taking longer. "Many factors are leading to evolving safety standards longer clinical times, including a focus on complex diseases and more complicated create challenges for drug developers development design protocols. Still in drug development, the race—and rewards— go to the swiftest and most efficient drug sponsors, those that can deliver safe new medicines in the shortest time," said Kenneth I. Kaitin, Tufts CSDD director.1 (January 8, 2009). Tufts Center for the Study of Drug Development. New drug development still takes eight years despite faster FDA review. 1 Reducing Risk with the Right CRO Partner Copyright © 2009 INC Research www.incresearch.com
  • 3. Page 3 Not only must a drug developer master efficiencies, it needs to address evolving safety requirements. "The trend at the FDA toward stricter safety standards has continued unabated and has arguably become even more onerous," found a Jeffries & Company report.2 Given these trends, selecting the right CRO is even more critical. "The simple truth is that pharmaceutical companies of all sizes need service providers more than ever. They need their resources, their global reach and, dare we say it, they need their clinical development experience and expertise," stated an ISR report.3 However, not all CROs are created equal and many sponsors are questioning their original criteria for selecting a CRO partner. • The Transparency Issue Poor communication is a Perhaps the biggest challenge working with a CRO is the lack of transparency. leading cause of Often, sponsor management teams don't have a clear view of a project’s status dissatisfaction with CROs at any given point during a trial. "There appears to be a direct correlation between the project manager's ability to manage the communications process and project performance," stated project management expert Harold Kerzner, Ph.D.4 Communication breakdowns happen when the CRO's site and sponsor relationships are weak. Faulty assumptions often prevail, problems remain unseen and unsolved, milestones go unmet and project budgets evaporate without conclusive results. Unfortunately, sponsors usually find out too little, too late to salvage the trial. • The 'C' Word Change is a risky and often costly proposition for many sponsors. Over time, Change is a costly sponsors grow accustomed to the people and processes put in place by existing proposition for most biopharms, regardless of CRO vendors—even when milestones fall short. Continuous CRO inefficiencies CRO inefficiencies and regular micromanagement are generally accepted routines. Windley, D. & Evans, T. C. (January 26, 2009). Jeffries & Company. Healthcare: Dissecting the outsourced drug development industry growth drivers. 2 (December 2008). ISR Reports. CRO differentiation. 3 Kerzner, H. (1998). Wiley. Project Management: A Systems Approach to Planning, Scheduling, and Controlling. 4 Reducing Risk with the Right CRO Partner Copyright © 2009 INC Research www.incresearch.com
  • 4. Page 4 The old idiom, "the devil you know is better than the devil you don't," often prevents change from occurring. It takes time and expense to evaluate a new CRO. New relationships, systems and people often lead to disruptions that can slow progress. Many clinical research executives are limited to CROs already sanctioned as preferred providers—lists to which they had little or no input. "Even though you have used the same CRO for years, because they are on your preferred provider list, you have basically entrusted your company's most valuable asset to strangers. What did you base your decision on? If your biopharmaceutical company is like most, you gave several CROs a brief synopsis of the compound in development… and told them to come back in ten working days with a budget, feasibility analysis, a strategy for patient recruitment and a timeline," stated an ISR report.5 Only time revealed if these decisions were wise. • Assessing New CROs "Buying services from CROs is not like buying a car. There is no JD Power, Kelley Blue Book or Consumer Reports that biopharmaceutical decision-makers can reference to get an independent analysis of CRO 'best buys,'" said an ISR report.6 Unfortunately, every CRO claims to be better, faster and cheaper. There is no simple way Complicating the issue is the fact that many departments within a sponsor company to judge the quality of an unfamiliar CRO, must be involved, including clinical operations, outsourcing, data management, complicating the quality assurance, IT, finance and regulatory. While clinical operations executives selection of a new one can eliminate a prospective vendor, it is much harder to propose a new one. However, once the strategic decision is made to outsource services, a process for selecting the right CRO must follow. "Let's face it, CROs are different. Some of them excel at relationship management, some use (December 2008). ISR Reports. CRO differentiation. 5 Ibid. 6 Reducing Risk with the Right CRO Partner Copyright © 2009 INC Research www.incresearch.com
  • 5. Page 5 technology better, some have a global reach that is unmatched and some are more cost effective," found an ISR report.7 While it's true that all clinical research must follow the same path to approval, the 'how' component is highly variable. Good people, technologies to support them and procedures that make the path less strenuous will smooth the road to success. The New Solution: Process-Driven Clinical Research Designed to eliminate inefficiencies and improve communication, process-driven Process-driven clinical research is a combination clinical research is a unique blend of people, processes, technologies and metrics of people, processes and implemented by CROs to greatly enhance the outcome of clinical trials. Taking technologies to help speed drug development proven project management techniques, adding expert consultation and leveraging the latest technologies, CROs are better able to predict and plan for the unexpected, maintain open channels of communication and ensure that sponsors meet their corporate milestones and objectives. The process-driven approach focuses on the entire stream of study activities from protocol design to the final study report. A wide range of experts participates to ensure the best possible outcome. By following proven processes, continually improving them and applying best practice project management techniques, the potential for risk is greatly reduced, costs are controlled and results are delivered. There are four primary phases of process-driven clinical research: Planning Phase: In this initial phase, the CRO acts as a consultant, reviewing the sponsor’s goals, objectives and priorities, and helps create the study strategy. The CRO brings therapeutic experts to the table to evaluate all variables related to the study. This phase is highly collaborative between the sponsor and CRO to establish a foundation of trust and confidence. Implementation Phase: In this second phase, all critical early-stage study activities take place to accelerate the study outcome. For instance, the responsibilities of (December 2008). ISR Reports. CRO differentiation. 7 Reducing Risk with the Right CRO Partner Copyright © 2009 INC Research www.incresearch.com
  • 6. Page 6 the CRO are determined, investigative sites are identified and contacted, and milestones are determined. A detailed review of risks, timelines and deliverables is performed. The goal is to approve and finalize all study plans and supporting documents in a rapid, yet thorough, fashion. Example activities include risk management planning, a feasibility survey, patient recruitment planning, data validation and the development of other plans essential to a successful study. Acceleration Phase: Execution is the heart of the third phase. Momentum builds with patient recruitment, treatment and monitoring. Trial and data progress is routinely examined. Risk management contingency actions are implemented to address problems as they occur. Performance metrics are also regularly examined. Issues are immediately communicated and rectified to prevent them from becoming obstacles in the progress of the trial. Final Phase: This phase begins as soon as the first enrolled patient completes the trial. Detailed estimates are established for the collection of data to hand off to a biostatistics team. With trusted data in hand, this step paves the way for refinements that will make future trials more successful. Proactive plans consider all closeout activities down to final database lock. Jo Bi 1s in d Aw tP tP D H D Al oc an at an 1s ar la ef D lS ie nn tS um d d d- en at nt ite N of a ite in se en rc ot C sI Ba fM g om M In ifi t R hiv Se ni se A ee iti ee ca tia et in ss pl Lo at tio tin tin RF ur g io te e ed c te n n d n g k P g Implementation Phase Final Phase Planning Phase Acceleration Phase Figure 1: There are four primary phases of process-driven clinical research Reducing Risk with the Right CRO Partner Copyright © 2009 INC Research www.incresearch.com
  • 7. Page 7 The Benefits of Process-Driven Clinical Research Process-driven clinical research provides many significant benefits to drug developers, including: – Reduces risks of lost time, poor quality and overspending Process-driven clinical research eliminates the communication challenges – Enables milestones to be achieved on schedule typically present with most CROs, greatly enhancing the efficiencies of trials – Provides access to experts who can foresee potential challenges and respond appropriately – Empowers the organization to quickly respond to challenges – Allows executives to easily convey the status of trials to others – Maintains flexibility while reducing risk – Reduces the transition time among various study stages – Allows concurrent execution of different phases of a study, speeding progress – Provides actionable data that enables intelligent business decisions that will impact the company’s bottom line Brief Example A sponsor working on a central nervous system (CNS) drug trial had to locate a difficult-to-find patient population. Using a CRO's existing relationship with Patient enrollment time was cut nearly in half using a high-quality investigators, the sponsor had confidence it would achieve its process-driven clinical enrollment goals. Nevertheless, contingency plans were established that could be research-based CRO implemented if enrollment lagged. After the trial was underway, a risk management trigger point indicated that enrollment might fall short. The CRO team implemented the contingency plans Reducing Risk with the Right CRO Partner Copyright © 2009 INC Research www.incresearch.com
  • 8. Page 8 with the sponsor’s agreement. As a result, enrollment was completed in 5 months as opposed to the anticipated 9 months. The outcome was faster study results and better informed decisions on the compound’s future. Had the sponsor not worked with a process-driven clinical research-based CRO, they would not have gained such efficiencies or confidence in the study results. How to Evaluate a CRO When looking for a CRO, When seeking a CRO, consider the be sure it provides on- following important requirements: demand experts and can provide in-depth benchmarks and In-depth benchmarks and metrics: A performance metrics CRO should employ comprehensive metrics to support its claims. Ask for discrete variables that track and measure specific sites, monitors, patients, IT and data metrics that help to prove that the CRO's process can increase the efficiency of a trial. Risk processes: Look for a company that can support its repeatable process and can identify and plan for risks to improve the probability of success. This should include alternative site selection and data management systems. On-demand experts: Seek a company that can immediately bring experts to the table to assist with project planning, metrics evaluation and execution. Data management system–agnostic: The ideal CRO should be able to work with existing best-of-breed data management systems, eliminating the need to invest in new systems. Team quality: To determine if strong chemistry will exist between the CRO and the sponsor team, assess the proposed trial team’s experience in similar trials. Communication systems: The best CROs employ the latest technology to streamline communication. Reducing Risk with the Right CRO Partner Copyright © 2009 INC Research www.incresearch.com
  • 9. Page 9 Full range of services: Advanced CROs can scale to accommodate any biopharm need, including drafting protocols, designing studies, and performing regulatory activities and post-approval studies. The CRO should also provide the appropriate global reach to ensure ready access to targeted patient populations. Extensive experience: Look for a CRO that has at least a decade of proven trial experience and is dedicated to the therapeutic areas in need. Pediatrics expertise: Seek a CRO that has extensive experience with your unique regulatory requirements and understands how to address the challenges of working with pediatric patient populations and their caregivers. The INC Research Advantage The Trusted Process® by INC Research is a proven metrics-driven methodology that reduces risk and achieves on-time, on-budget results for clinical trials, meeting all of the requirements outlined in this paper. Eight of the top ten biopharmaceutical companies rely on INC Research's Trusted Process. Eight of the nation's top ten pharma companies INC Research has managed complex clinical trials for more than 20 years. With rely on INC Research to a strong therapeutic focus, the company provides scientific experts that anticipate manage their critical clinical trials and plan for common pitfalls and develop plans to mitigate them. INC Research employs experienced, regionally based professionals in clinical services, data services, late phase services and therapeutic expertise areas. Equipped with the knowledge of local languages, cultures and regulatory requirements, each location offers a complete range of customized Phase I - IV clinical trials and ancillary services. Reducing Risk with the Right CRO Partner Copyright © 2009 INC Research www.incresearch.com
  • 10. Page 10 Providing continuous operational metrics through its Trusted Process, sponsor teams are aware of progress at all stages of a trial. Results-driven, INC Research can prove how it consistently helps sponsors achieve their milestones to ensure they make highly informed and confident decisions. As measured by its Trusted Process, INC Research customers experience: – Project enrollment completed on average three weeks ahead of schedule – Database lock on average over three months ahead of schedule Let INC Research instill a new sense of confidence in your clinical trials. For a FREE pressure test on your study plan, email pressuretest@incresearch.com or for more information call 866-462-7373 or visit www.incresearch.com/trusted_process/ Reducing Risk with the Right CRO Partner Copyright © 2009 INC Research www.incresearch.com