7:00 am Registration and Morning Coffee
8:00 Welcome & Chairperson’s Opening Remarks
8:15 Clinical Trial Vendor Selection: Selecting the Right CRO Strategic Partner
Jennifer Gaskin, CCRP, Operations Director, Clinical Operations, Alliance for Clinical Trials in Oncology (Alliance Foundation Trials, LLC)
Selecting your strategic partner CRO is a daunting task and a large commitment for any organization. The CRO options range from the large, publicly owned companies with a comprehensive menu of services and global resources to privately owned niche providers specializing in specific therapeutic areas. CRO offerings and budgets vary significantly which impedes the ability to do direct comparisons. This session discusses the steps and best practices in the process of selecting the correct CRO partnerships for your organization.
8:50 Re-Engineering the RFP and Bid Defense Meeting Manage Risk and Quality
Liz Wool, RN, BSN, CCRA, CMT, President and CEO, QD-Quality and Training Solutions, Inc.
This session reviews the re-engineering of the RFP and bid-defense meeting to target identification of risks for the potential services to be awarded to your CRO, vendor, or supplier, whether a preferred partnership model, a “company approved list,” or based solely on project needs. We will build upon the gaps identified in the selection scoring tool/capabilities assessment tool of preferred provider models to drive the Bid Defense Meeting agenda. The selection activity is the opportune time for assessment of capabilities and risks associated with business methods, processes, services, people, and technology. This new approach also gives the provider the opportunity to communicate their ability and willingness to adjust their approach and methods beyond the RFP, thus beginning a dialogue regarding management and quality oversight methods early on in the partnership, with known risks and gaps identified by stakeholders. This improved process drives business efficiencies and cost savings now, rather than later during trial execution, identifying impact on protocol and data integrity if performance is inadequate.
Ashley Hatcher, Senior Consultant, Vantage Partners
Alliances and “strategic partnerships (between large pharma companies, small bio-techs, and academic institutions) are increasingly pervasive. But what about “alliances” between bio-pharma companies and CROs? Are true partnerships with CROs (and other suppliers) really possible? What are the risks and benefits of moving beyond a traditional customer-vendor paradigm? In this interactive session, we will explore these and other issues using a number of case studies, and will also discuss how to adapt best practices for strategic outsourcing from other industries to the clinical development context.
9:55 Networking Coffee Break and Exhibit Viewing
THIRD PARTY COMMUNICATION AND COLLABORATION
10:25 Establishing a Strong Communication Channel with Your Third Party Vendor
Nicole Yingst, MBA, CCRP, Patient Recruitment Specialist II, PAREXEL International
Successful vendor relationships have many components, but a key factor is a solid communication pathway. Transparency, upfront goals, and ongoing, organized touch points are vital in establishing and evolving a strong partnership that will lead to a successful project and long-term business. This is seen as a benefit for your company and your clients, as they will reap the benefits of the efficiencies and discounts generally established through longstanding vendor relationships. Attendees will be presented with crucial steps in developing a solid communication pathway with vendors, learn from real-world scenarios, and apply key concepts to their own practices, customizing them to make their own successful pathway in working with their vendors.
11:00 Interactive Roundtable Discussions
11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:00 pm How Will Risk-Based Monitoring Change Your Relationship with Your CROs?
Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd.
In recent months, the Amgen Oversight Team was asked to add a new vendor to our Functional Service Provider (FSP) model. In the following items, your speaker will discuss some of the ways in which her team managed the site transitions and successfully balanced their FSP model across vendors:
• Discussion on managing two vendors in an FSP model; collaboration between vendors
• Proactively managing risk-based on triggers and red flags
• Multi-layer approach to Quality Oversight and Supplier Governance
• Maintaining complete documentation in the TMF
• Ongoing training with the new vendor; i.e., systems, processes, documentation
• Lessons learned from transitioning sites from one vendor to another
1:45 Effective CRO Oversight in a Strategic Outsourcing Model
Joe Pollarine, Director Quality Monitoring & Compliance - Bioresearch Q&C, Janssen R&D – Springhouse US
Outsourcing to a CRO provides opportunities to pharmaceutical companies to delegate a significant part of the trial activities to an external organization. However, the sponsor organization ultimately remains accountable for the integrity of a clinical trial, and therefore, needs to keep oversight and control on the safety of patients and the integrity and credibility of data while managing timelines and budget. The presentation provides an example of how a sponsor can maximize a successful outcome from outsourcing by:
• Establishing a partnership with a preferred CRO provider
• Allowing the CRO to run trials using their own processes and way of working as much as possible
• Creating efficiencies by eliminating redundant activities
• Keeping effective and efficient oversight to position a trial for regulatory filing and marketing approval
2:30 Case Study: Lessons Learned in Developing a Metrics Program to Monitor the TMF at a Vendor
Vinita Leslie, M.A., Director, Trial Master File Process Owner, Knowledge, Records & Information Strategies, Biogen Idec
2:45 Sponsored Presentation (Opportunity Available)
3:15 Networking Refreshment Break and Exhibit Viewing
3:45 Successful Collaboration and Merging of Multiple Vendors within an FSP
Erika Vento, MBA, Clinical Trials Oversight Manager (CTOM), Amgen, Inc.
Erik Olson, MPH, Clinical Trials Oversight Manager (CTOM), Amgen, Inc.
Monitoring in clinical trials has in the past always been a “routine machine” that sent monitors with a regular frequency to sites to do mostly Source Data Verification (SDV). Data from CSDD Tufts University show that the burden on CRAs grows every year and this is only one reason among many that the classic approach to monitoring does not work anymore. Risk-based management of clinical trials is the methodology that is currently recommended by regulators, however it has some direct consequences on monitoring and clinical trial oversight. With Risk-Based Monitoring (RBM), visits to sites will not include SDV anymore, with some exceptions, and the Monitor has to become rather a coach or mentor to the sites as it was originally intended. This change, however, brings another consequence with it: the CRA job will mostly not be an entry job anymore. CRAs will have to be more senior to be able to talk to the investigators on the same level. When considering all this, what consequences will this have on your relationship with the CROs? This presentation will provide answers.
MANAGING OUTSOURCING QUALITY
4:20 Case Study: Managing Quality in an FSP Monitoring Model
Erik Olson, MPH, Clinical Trials Oversight Manager (CTOM), Amgen Inc.
Amgen has been operating in an FSP (Functional Service Provider) Clinical Monitoring Model for over seven years now, and uses a robust Clinical Monitoring Quality Oversight Plan to ensure that quality is measured consistently across regions globally, and across FSP providers. Having multiple FSP providers globally, with each following Amgen SOPs and using Amgen systems, has contributed to the success of the FSP model implementation. We have refined both the metrics we use to check monitoring quality on an ongoing basis, and now have a defined and transparent, collaborative process to report, monitor and manage both serious monitoring and serious site quality issues from issue identification through resolution.
4:55 Reception and Exhibit Viewing (Sponsorship Opportunity Available)
5:45 Short Course Registration
5:55 Close of Day One
7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:15 Chairperson’s Opening Remarks
8:20 Adopting Standardized Time, Quality, and Efficiency Performance Metrics Across Your Vendors
Linda B. Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)
In this session, we will present data from the Metrics Champion Consortium (MCC) industry update, and address key areas related to vendor management, such as:
• Utilizing metrics to assess your vendor relationships
• Metric updates to support quality-by-design approaches
• New performance metrics from emerging “e” system vendors (e.g., eCOA, eTMF)
8:55 Using Performance Metrics to Manage Vendors in Clinical Trials
Michael Howley PA-C, Ph.D., Physician Assistant – Certified Faculty Coordinator, MBA Healthcare Concentration, Associate Clinical Professor, Department of Marketing, LeBow College of Business, Drexel University
Sponsors of clinical trials understand their responsibility to oversee and manage their vendors. They are often frustrated, however, by metrics that do not provide adequate oversight of their trials until after the trial is completed. In this session, your speaker will show you how to select scientific performance metrics - or to develop your own measures - that will be valid and reliable. Attendees of this session will be able to provide scientific oversight and management of their clinical trials as they unfold.
9:15 Sponsored Presentation (Opportunity Available)
9:30 Networking Coffee Break and Exhibit Viewing
10:00 Using Warning Letters to Prepare for BIMO Inspections
Valerie Rosemond, Quality Assurance, Johnson & Johnson Vision Care
A Bioresearch Monitoring Inspection from the FDA may delay a product’s entry to the market by an average of 14 months and cause the company significant market share to their stakeholders. Companies that receive these types of inspection letters cause additional delays in responding to the regulatory agency. Current trends indicate errors occur despite resources devoted to monitoring, QA audits, and other surveillance or quality activities. Systematic errors can render trial data unreliable and may be unrelated to activities at the clinical investigator sites. The need for proactive risk-based activities is crucial, as is training subject matter experts and researchers for inspection readiness. In this session, we will identify and describe the required areas of specialization and the associated general competencies for investigators in these areas of specialization.
10:35 Case Study: Managing Risks During Project Transition: Person to Person, Team to Team, Sponsor to Vendor, and Vendor to Vendor
Donelle Bussom, RN, MSN, Senior Director, Medical and Safety Services, ICON Clinical Research
Whether you are a pharmaceutical company, CRO, or other service-providing vendor, in the small world of pharmaceutical research, chances are that you have faced some sort of project transition. Project transition comes in many forms: transitioning internally from person to person, team to team, or even vendor to vendor (including transitioning internal projects to external vendors). While there are many reasons for transition, the main reasons typically involve issues around quality, resources, finance, or expertise. Even though we face these situations on a daily basis, transitioning projects is a very risky endeavor for all parties. In this presentation, we will review how to best plan transitions to reduce risks and ensure a smooth handover process through a step-wise approach and case study analysis.
11:10 Sponsor Oversight: The Importance of Auditing in Vendor Management
Beverly Brown, Manager, Global Regulatory Quality, Allergan
11:45 am Close of Conference
6:00 - 8:30 pm DINNER SHORT COURSE:
(SC2) Quality by Design in Clinical Research: Is This Only for the Protocol?*