- Technology and new developments when it comes to managing CRO relationships
- How to ensure your study is prioritized
- Maintaining a strong relationship with vendors in remote and hybrid work settings
- How to blend a CRO team with your internal team in order to foster communication and overall success of your trial
- CRO monitoring and oversight: how to make processes efficient and effective
Archives: Agenda
Best practice for biopharma and advocacy group collaborations in order to boost recruitment for trials
- How successful collaboration with advocacy groups can boost recruitment and enrolment
- Strategies for building effective partnerships with advocacy groups
- Utilizing patient-centric approaches to enhance trial recruitment efforts
- The impact of a patient-focused trial design on accelerating timelines
Propelling asset development through integrated regulatory, clinical, and medical expertise
- Discover the benefits this model brings to strategic asset development
- Understand the optimal timepoints for CRO engagement
- Discuss tips for maximizing your CRO’s expertise to support a comprehensive development plan
- Review real-world examples demonstrating the advantages of this approach
Applying Lean Six Sigma methodology to reduce the lead-time of clinical contracting
- Clinical contracting is on the critical path to trial start
- It is a process where bottlenecks and root causes can be identified via data analysis
- Lean Six Sigma methodology can help to significantly reduce contracting lead-time
Afternoon refreshments and networking break
End of Conference
PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS
During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations. Roundtables will take place in the Stream A conference room.
| ROUNDTABLE 1: Importing and exporting biological materials to or from the U.S
Sean D. Smith, Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection Baljeet Kaur, Agriculture Operations Manager, U.S. Customs and Border Protection |
| ROUNDTABLE 2: Pros and cons of different outsourcing models: FSO vs FSP vs inhouse
Yolanda Wan, Head of Clinical Operations, Orna Therapeutics |
| ROUNDTABLE 3: Enabling the most inclusive approach to patient engagement
Lily Cappalletti, Director, Patient Experience, Alexion Pharmaceuticals |
| ROUNDTABLE 4: Topic TBC
Kate Tith, Vice President, Head of Clinical Operations, Dyne Therapeutics |
| ROUNDTABLE 5: Building efficient and effective relationships with sites
Peter Koefler, Director, Study Site Engagement, Takeda |
Importance of forecasting clinical trial enrollment: an AI enabled approach to increase confidence in feasibility and execution
- Learn how to pressure-test site footprint through predictive analytics by forecasting enrollment at the country and site level
- Discover methods to run re-forecasts based on actual study performance for more accurate tracking and adjustments as necessary
- Gain competitive advantage thru actionable insights to remain agile and avoid costly enrollment delays
- Learn how to leverage data to identify low-performing sites earlier in the trial process to implement effective risk mitigation tactics
EXHIBITION APPLE PRIZE DRAW
Visit our exhibitors’ booths throughout the conference and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!
Considerations for successful third party vendor management
- What degree of oversight should you have over third party vendors?
- Risks and benefits of handing third party management to CROs
- Regulatory and quality considerations around outsourcing to third party vendors