Barnett International/CHI’s Third Annual
Vendor Management in Clinical Trials
Ensuring Quality through Effective Assessment,
Qualification, Auditing, and Oversight
June 2-3, 2014, Hilton Boston Back Bay, Boston, MA
With growing reliance on third party providers in clinical trials, the need for effective selection and oversight of vendors is more important than ever. Barnett International/CHI is pleased to announce a Call for Speaker Proposals for our third annual Vendor Management in Clinical Trials conference, an event that addresses 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.” This event will feature thought leaders who will share their experiences with all types of third party vendor relationships, including clinical research organizations, core labs, and software providers. Abstracts are sought regarding risk-based approaches to vendor management, all phases of the vendor relationship from assessment to oversight. Submissions from sponsor/vendor partners are encouraged. Submissions that feature case studies, take-away tools, perspectives on the current regulatory environment, breakout groups, and interactive activities will be given preference.
We invite presentations on topics such as:
- Risk-Based Approaches to Clinical Vendor Management
- Implementing a Quality Management Approach to Clinical Vendor Selection and Oversight
- The Sponsor/Clinical Research Organization Relationship: From Conception through Evolution
- Oversight of Other Third Party Vendors: Core Labs, Academic Research Organizations (AROs), Site Management Organizations (SMOs), Software Providers, Electronic Patient-Reported Outcomes (ePRO) Providers
- Building a Partnership Relationship with Your Third Party Vendor
- Ensuring that Your Third Party Vendors Are Inspection Ready
- Strategies for Vendor Qualification: Strategies, Questionnaires, Pre-Qualification, and Risk Assessment
- The Contracting Process: Defining the Scope of Work, Budgeting, and Building Quality and Accountability into the Contract
- Effective Strategies for Ongoing Oversight of Third Party Vendor Oversight
- Global Vendor Management: Special Considerations when Contracting Internationally, including in Emerging Regions
- Clinical Research Sites as Vendors: Assuring Quality and Managing Relationships
- Addressing Quality Issues: Corrective and Preventive Actions (CAPA), Follow-Up, and Escalation Plans and Procedure
- Clinical Vendor Audit Logistics, Preparation, Conduct, and Reporting
- Strategies for IRB Evaluation, Selection, Compliance, and Regulatory Considerations
- Preparation and Oversight of a Vendor Partner’s Regulatory Inspection
Industry professionals with best practice case studies and other thought leaders are encouraged to submit a session title, summary of a proposed presentation, and brief biography for consideration.
The deadline for priority consideration is November 15, 2013.
All proposals are subject to review by the program Advisory Committee to ensure the overall quality of the conference program. Please note that due to limited speaking slots, preference is given to abstracts from those within pharmaceutical and biotech companies, regulators, and those from academic centers. Additionally, as per Barnett/CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
To submit a proposal for consideration, please click here.
For more information, please contact:
a division of Cambridge Healthtech Institute
For exhibit and sponsorship information, please contact:
Manager, Business Development
Cambridge Healthtech Institute