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Thought leadership at the boardroom table
Since its inception in 2011, Linking Leaders roundtables have become a priority spot on our members’ calendars. Our meetings are considered as having the best representation of senior-level decision makers and influencers coming together on a regular basis. The dynamic and collaborative environment allows for candid discussions not found at traditional events.
Linking Leaders members agree that it is not only in the interest of the executives around the table, but also in the best interests of patients to share learnings across the industry. There are only gains to be made from this forum where leaders gather throughout the year to engage, exchange and, ideally, effect change.
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Linking Leaders hosts roundtables in the following functional areas:
Clinical Operations
Linking Leaders' Clinical Operations Roundtable brings together an exclusive community of senior-level clinical operations executives to discuss collective challenges and collaborate on new ways to drive efficiencies in executing clinical trials.
Discussions focus on strategic thinking and best practices for:
- FSP Model Trends, Challenges and Opportunities
- Recruitment, Development, and Upskilling Talent for the Next Decade
- Leveraging Opportunities to Recruit, Develop, and Support New PIs
- Site Startup/Activation and Simplifying Interfaces with Sites
- Improving the Site Contracting Process
- Optimizing Protocol Development
- Accelerating Clinical Innovation Through AI
- Considerations for Oncology Studies in
the US - Addressing Challenges with Lab Providers
- Partnerships and Evolving Sourcing Models
. . and much more
Linking Leaders also hosts Clinical Operations Roundtables for Small BioPharmas
on the East and West Coasts, designed to meet the unique needs of companies with fewer resources.
Areas of focus for small biopharma companies include:
- The Current Talent Landscape and Doing More with Less
Growth of the Clin Ops Group: Roles, Processes, Infrastructure, and Core Competencies - Shift in Geographies for Trial Conduct: US vs Emerging Regions
- Managing Expanding Data Demands and Integrating AI in Operations
- Including the Voice of the Patient in Study Design and throughout the Trial
- Vendor Oversight Strategies
- Understanding and Addressing Site Challenges
- Patient Recruitment and Retention
- Inspection Readiness and Meeting Global Compliance Expectations
- CRO Selection and How CROs Can Better Meet the Needs of Small Biopharma
. . . and much more
Clinical Quality
Linking Leaders' Clinical Quality Roundtables
bring together an exclusive community of executives engaged in Clinical Quality Assurance, Compliance, and Pharmacovigilance to share best practices for proactively executing quality in clinical trials.
Strategic level discussions focus on:
- Inspection Readiness and Management
- Lessons Learned from Integrations Due to Collaborations, Partnerships, and M&A
- CRO Governance and Oversight
- Update on the Quality Brief Initiative
- ICH E6 R3 Implementation
- Management of Misconduct/Persistent Non-Compliance at Sites
- Recent Inspection Experiences: Trends and Best Practices
- Developments in the Use of AI
- Quality’s Role in Integrating QRM and Central Monitoring
- Quality Process around Important Protocol Deviations (IPDs)
- In Vitro Diagnostics, Performance Studies, and Compliance with the IVDR
- Use of Data Analytics in Clinical Quality
Linking Leaders also hosts Clinical Quality Roundtables
to meet the unique needs of small biopharma companies.
Areas of focus for small biopharma companies include:
- Sponsor Oversight of CROs, other Vendors, and Sites
- Use of Quality Councils
- Evaluating and Reporting Serious Breach
- Inspection Intelligence: Trends, Insights, and Best Practices
- Data Integrity
- Best Practices for Embedding Quality in Early Phase (Rare Disease) Trials
- Quality’s Involvement in the Use of Technology
- Accommodating a Lack of Quality Presence at CROs
- Promoting a Quality Culture in an Environment Focused on Speed
- Inspection Readiness
- Quality Risk Management
- Finding, Developing, and Retaining the Next Generation of GCP Talent
- How GMP, GLP, and GCP QA Can Work Better Together
Clinical Outsourcing
Our Clinical Outsourcing Roundtable
presents a unique platform for clinical outsourcing and procurement executives to address collective challenges, best practices, and innovative methods for sourcing in a dynamic global landscape.
Our members benefit from collaborative dialogue on:
- Evaluating the Health of a Partnership
- Building Efficiency Expectations into Vendor Contracts
- Optimizing Vendor Selection and Qualification
- Use of AI in Outsourcing and Trial Execution
- Outsourcing Model Shifts
- Innovation in Governance
- Vendor Management and Oversight
- Outsourcing’s Role in Study Startup
. . . and much more
Medical Writing
Our Medical Writing Roundtable
gathers heads of regulatory medical writing to benchmark current and future status, practices and standards, and technology advancements for medical writing.
Participants discuss shared challenges and novel approaches to:
- The Future of the Medical Writing Profession: Value, Identity, and Readiness for 2030 (and Beyond)
- Workforce Planning, Resourcing, and Forecasting
- AI and Automation in Practice
- Health Authority Expectations, Evolving Submission Paradigms, and AI Impacts
- Trends in Medical Writing Outsourcing Strategies
- Managing EU CTR/RFIs/Disclosure
- . . . and much more