Day 2 - 17th October - EST/EDT (Eastern Daylight, GMT-4)
- Kerry Armstrong - Associate Director, PDCS Clinical Supply Management IRT Systems, Alexion Pharmaceuticals, Inc.
- How can choosing the correct IRT system help optimize supply, reduce costs, and eliminate unnecessary waste in supply chains?
- Automated processes and how this simplifies logistics.
- Integrating or transferring data between IRT and forecasting systems to compare planned versus actual.
- Kamal Amin - Head Of Supply Chain Management, Galderma
- Irena Seredina - Executive Director, S-CLINICA
- Aiste Stulpiniene - Clinical Supply IRT Lead, F. Hoffmann-La Roche Ltd
Almac will provide and informative and personal guide, looking at IRT through the history of the regulatory requirements and how they have changed with time; looking at current quality and regulatory requirements and engage the audience in how we should move forward as an industry.
- Matthew Lowrie - Associate Director - QA & Regulatory Compliance, Almac
- What does "modern" mean in today's RTSM world
- Aligning RTSM with broader technology practices
- Sponsor communication leveraging today’s tooling
- John Ranz - Chief Technology Officer, Atreo
- What do actual end users want (including sponsors and sites)
- What standardisation is required around systems and what does this look like?
- Tech integration for different end users – needs and requirements.
- How can we make systems use friendly to ensure that IRT and supply chain managers can work hand in hand to get the right product to the right patient?
- IRT vs. RTSM
- Marc Lava - RTSM Product Owner, Johnson & Johnson
- Kerry Armstrong - Associate Director, PDCS Clinical Supply Management IRT Systems, Alexion Pharmaceuticals, Inc.
- John Maggard - Senior Manager, IRT Systems, AbbVie
- Manish Kumar - Senior Director, Software Development, Oracle, USA
- Helen Greta - Director, Project Management, IQVIA Technologies, USA
- How you differentiate between e-tech like eCOA or e-consent?
- Are these technologies better integrated or as stand alone?
- When using these how do you prevent IRT just becoming a clinical database?
- Bryan Clayton - Founder, BC Consulting
- Planning and Implementation of a new integration
- Establishing standards and SMEs
- Refining and Improving for the future
- Sarosh Anjum - IRT System Owner and Lead, DigitalX, Astellas
- Sara Liu - Client Delivery IQVIA IRT, IQVIA Technologies, USA
- Tony Warren - Director, Tech Product Management, Sitero, USA
Every study faces the unexpected. Operationalizing a clinical trial is a race against time, often filled with unforeseen challenges. With a right-fit RTSM solution, you can better navigate obstacles, solve problems under pressure, and meet key milestones.
Discover the importance of being perceptive through:
- Listening to the past – learning from building & supporting 30 years’ of trial designs
- Staying present – ensuring that the fundamentals are right every time
- Looking to the future – understanding industry challenges and applying past learning to them
- Ash Patel - Associate Director Project & Program Management, Perceptive, USA
- Integrating and building reports across protocols
- How can data from IRT systems be analysed and influence shipping etc to cut costs.
- Working to create more efficient systems vs. having to make the same change across multiple systems and studies.
- Meghan Hasson - RTSM Process Owner, Johnson & Johnson
Case Studies of RTSM Failures:
Explore real-world examples of studies where poor RTSM practices led to significant issues, such as supply shortages, randomization errors, or unblinded data, highlighting the impact on study integrity, timelines, and patient safety.
Identifying and Avoiding Common Pitfalls:
Discuss the key lessons learned from these failures to ensure the integrity throughout the trial.
Best Practices for Successful RTSM Implementation:
Provide actionable strategies for mitigating risks in RTSM, such as implementing regular system audits, enhancing communication between study teams and vendors, and adopting adaptive supply strategies to ensure trial success.
- Barry Moore - Head of RTSM, GSK