- Reviewing outsourcing models from FSO, FSP and fully inhouse
- Determining the best outsourcing model: pros, cons and assessment tips to consider
- Selecting the right model and partners to fit your needs, optimizing cost and efficiency
- Reducing barriers and highlighting benefit of QA cross departmental collaboration
- Embedding QA input into outsourcing strategy, contracting and oversight
- Working together with QA for risk mitigation and inspection readiness
- Vendor selection audit strategy
- Consider the best problem to solve isn’t the most “obvious” problem.
- Rethink vendor oversight as a shared-risk partnership problem, not a monitoring problem
- Design resilience into trial delivery through problem anticipation, not reaction
- Reframe “inspection readiness” as solving for trust and transparency, not just checklist compliance
- Selecting recruitment partners and collaborating with advocacy groups, patient organizations and care givers to extend patient reach
- Communicating effectively and working together with sites to assist in recruitment
- Complying with regulation across differing therapeutic areas
- Finding innovative solutions to reduce patient burden
- Sharing tips for dealing with regulatory uncertainty whilst keeping your trial on track
- Complying with FDA data requirements
- Managing funding cuts and changing tariffs
- Keeping abreast of updated guidelines and policy shifts
- Highlighting the fast-evolving development of multi-agent AI tools available
- Using humanoid robots to carry out motion-based tasks in the laboratory and the workplace
- Understanding how multi-agentic systems can support and improve different phases, operations, and processes of clinical trials
- Improving the design, enrolment, execution, analysis, results, and reporting in clinical trials with multi-agent systems
- Ensuring patient understanding of rights and informed consent
- Reaching underserved communities and reducing enrolment stigma
- Running trials more efficiently and effectively with patient burden in mind
