With growing reliance on third party providers in clinical trials, the need for effective selection and oversight of vendors is more important than ever. At the third annual Vendor Management in Clinical Trials conference, we will address the need for quality in the assessment, contracting, implementation, auditing, and ongoing oversight of third party vendors. With growing regulatory expectations for a quality systems-based approach to GCP compliance, sponsors must be certain that their third party vendor partners are “inspection ready.” Participants can expect presentations on risk-based approaches to vendor management and all phases of the vendor relationship from assessment to oversight. The event will feature case studies, take-away tools, perspectives on the current regulatory environment, breakout groups, and interactive activities that will enhance participants’ expertise.
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Monday, June 2, 2014
7:00 am Registration and Morning Coffee
8:00 Barnett Welcome & Chairperson’s Opening Remarks
8:15 A Study of Outsourcing Models: Options, Approaches, and Impact
Mary Jo Lamberti, Ph.D., Senior Research Fellow, Tufts Center for the Study of Drug Development
Tufts CSDD is conducting a study among top 10 to 12 biopharmaceutical companies to capture specific use of outsourcing models (e.g., FSP, niche, hybrids, integrated alliances). In this study, Tufts CSDD will analyze specific collaboration and risk-sharing models being utilized, their impact on performance, and efficiency to date. The study will also explore ways in which organizations have adapted, and plan to adapt, their collaboration models to achieve greater efficiencies and best practices. The study will benchmark the incidence and impact of various organizational approaches through gathering company data. Company data will be analyzed to provide insight into the structure and type of outsourcing models, transitioning and management of resources and the impact of these collaborations on key performance metrics.
9:00 Strategies for Vendor Qualification: Strategies, Questionnaires, Pre-Qualification, and Risk Assessment
Treena Jackson, MS, CQA, RAC, CSSGB, Supervisor, Office of Quality Assurance, RTI Health Solutions
Norlonn A. Sturdivant, MT, RAC, Director, Office of Quality Assurance, RTI Health Solutions
Regulatory agencies expect that there are quality expectations set for outsourced work and sponsors are evaluating the vendors on quality with respect to the deliverables. Clinical vendors and CROs play key roles in contributing to market approvals, regulatory deliverable and overall clinical research. It is the sponsor’s responsibility to ensure their vendors meet all regulatory specifications for the supplied materials, equipment and/or services. In this session, the audience will gain knowledge regarding the following:
- Strategies for selection, audit, approval, and qualification of vendors based on the service/product being delivered
- Methods and tools used to accomplish a vendor pre-qualification and ongoing qualification
- Risk assessment strategies to determine the timing, method, and nature of audits
9:45 Coffee Break and Exhibit Viewing
10:15 Fundamental Processes for Optimizing Management of Contracts and Financials
Sally Teeters, CCRP, Senior Director, Legal and Business Management, CardioVascular BioTherapeutics, Inc.
This presentation will provide a brief overview of SOX with emphasis of the challenges and impact on sponsors and CROs. We will also discuss the importance of planning and processing of RFPs. Your speaker will facilitate discussion of critical contract terms (e.g., confidentiality, IP, indemnification, insurance) and the “other terms” which tend to be considered non-critical but may have a major impact depending on the circumstances. Examples of other items include introductory provisions, assignment, relationship of parties, venue/choice of law, term and termination, record retention, on-site inspections, and change in personnel. The best practice of minimizing expense and processing of change orders by specifying the format, timing, and approval process will be discussed. Finally, managing financials will be addressed, including EVM, gain quick, and accurate visibility into clinical operations budget performance integrated with your financial and operational plans.
11:00 Interactive Roundtable Discussions
11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:00 pm Early Outsourcing and Vendor Management
Laura K. Vessey, BS, Director, Early Stage Development Operations and Outsourcing, Merck
What adds up as a conclusion on one side is often misunderstood on the other. The need for defining parameters goes beyond contracts. The understanding of the vendor and the client is easily forsaken if the ends are understood before the means are clear. Often, both sides are talking to their understanding but not realizing they are speaking apples and oranges. This is the voodoo of the argument. Make both understand what you mean, so that with an audit by a client there is not the amazing response of “I didn’t ask you to do that...,” so to speak.
1:45 Risk-Based Approaches to Clinical Vendor Management
Ken Shitamoto, MS, PMP, CPRE, Kikai Consulting, LLC
As outsourcing to third parties becomes more pervasive and is used more often for critical functions, the need for effective vendor management increases. Unless we can find efficient ways to perform this effectively, the cost of vendor management will increase significantly without necessarily increasing the quality of delivery. This session provides an overview of risk management models, and provides a road map for developing and applying risk-based vendor management in clinical trials.
2:30 How Risk-Based Approaches Affect Working with Your Service Providers
Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd.
The fact of the matter is that strategic partnerships do not always work. One major reason is the disconnect between protocol development at the sponsor and setting up the clinical trial subsequently at the CRO. Protocol amendments are typical before the trial even starts, followed by amendments related to safety or new regulatory requirements. Risk-based management will have a major impact on working with your service providers, especially regarding protocol development and data management. The latter plays a major role in risk management, since regulators’ expectations are that all assessments are based on facts collected during the trial. In addition, RBM needs to be developed jointly with your CRO, requiring a re-thinking of your outsourcing relationship and oversight.
3:15 Sponsored Presentation (Opportunity Available)
3:30 Refreshment Break and Exhibit Viewing
3:50 The Key Drivers of CRO Performance
Michael Howley, Ph.D., Associate Clinical Professor of Business, LeBow College of Business, Drexel University
How do you know if you are getting your money’s worth from your clinical trials? While clinical trials are usually one of the most expensive line items for life sciences companies, this is a very difficult question answer. Managers can waste a lot of time, money, and effort on performance metrics that don’t give them the information they need to improve their clinical trials. In this session, the results of the Clinical Trials Outsourcing Project (C-TOP), an academic-industry collaboration that has been working on developing validated instruments to assess CRO performance, will be presented. At the end of this presentation, attendees will be able to recognize performance metrics that are valid and reliable, and identify and focus on the significant and substantial drivers of performance assessment.
CASE STUDY! 4:35 The People Challenges of Implementing a Vendor Oversight Capability
Susan Giddens, Senior Training Manager, Process & Training Management, gRED Clinical Operations, Genentech
Kirsten Morasco, Vice President, Clinical Quality & Compliance, Compliance Implementation Services
Holly Deiaco-Smith, Change Management and Process Improvement Expert, Compliance Implementation Services
Why is it so difficult for study sponsors to perform good vendor oversight? Our presentation will answer this by providing insight into the behavioral and change management challenges that come with implementing a vendor oversight capability. What is a VO Capability? Why is it a “Big Change”? What does that mean for an organization? Your presenters will share the common challenges organizations face when they change their outsourcing model and ultimately implement a VO capability. Susan Giddens of Genentech will share her organization’s real-world experience of how they recently underwent a change in their outsourcing model and began implementing a VO capability. She will discuss and provide practical advice on how Genentech addressed these challenges through a comprehensive training and change management approach.
5:20 Welcome Reception and Exhibit Viewing (Sponsorship Opportunity Available)
5:45 Short Course Registration
6:00 – 8:30 Short Course 1, Best Practices to Becoming a Preferred Site (see Short Courses for additional information)
6:20 Close of Day One
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