- Who is LifeArc?
- The Rare Disease Challenge
- LifeArc’s Approach to Accelerating Clinical Research
- Translational Centres for Rare Disease
- Rare Disease Clinical Trials Programme
Archives: Agenda
AI for impact – transforming clinical trial study design and execution
Harnessing the convergence of high-fidelity data with advanced AI is now essential for de-risking clinical trials and accelerating therapies to patients. What if the distance between a draft protocol and a validated study execution plan was reduced to a single, unified simulation?
Join Medidata’s Eleanor McLaurin for a deep dive into the future of holistic trial design and planning. Learn how advanced modelling and simulation capabilities within a central workspace can revolutionise trial operations. This session will illustrate Medidata’s strategy for optimizing protocol design, predicting trial outcomes, and achieving greater clinical and operational success in the next generation of drug development.
The RFP Paradox: Why your vendor selection process may be limiting your options
- The hidden assumptions embedded in RFP design that narrow vendor capabilities
- How RFP structure shapes partnership dynamics and long-term outcomes
- Rethinking RFP strategy to access broader CRO expertise and innovation
Winning The Proof-Of-Concept Race Site Practical Insights and Tactics on What it Takes to Succeed in Competitive Indications
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Afternoon refreshments, networking, and Apple Prize Draw
Afternoon refreshments, networking & Apple prize draw
Lunch and networking
Key regulatory considerations around data quality when using real world data to support clinical trials
- How real-world data (RWD) can be used to support clinical trials
- Illustrative example using UK electronic healthcare records
- Key MHRA guidance on RWD for clinical trials
- Regulatory requirements data quality
- Transparency reporting recommendations
PANEL DISCUSSION: Designing Oncology Trials That Work for Every Patient
- Tackling barriers that limit access and participation for under-represented patient groups.
- Ensuring cultural relevance, language accessibility and equitable site selection.
- Embedding PROs and patient insights to shape inclusive eligibility and trial procedures.
- Measuring what matters: evaluating the impact of patient-centred designs on recruitment and retention.
CASE STUDY: Gene Therapy in Action: Advancing a Clinical Case Study in Childhood Dementia
| This session will explore the translational journey of a novel gene therapy targeting childhood dementia, from early research through to clinical trial readiness. Using a real-world case study, it will highlight the scientific, regulatory, and operational challenges involved in bringing a cutting-edge therapy to patients, and what this means for outsourcing partners across the UK & Ireland.
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