Day 1 - 16th October - EST/EDT (Eastern Daylight, GMT-4)
Day 1 - 16th October - EST/EDT (Eastern Daylight, GMT-4)
- Craig Mooney - IRT Expert, Independent
A. Why IRT could benefit a FIH/early phase trial
B. Designing an IRT System for FIH/early phase trials
C. Case study evaluation: Successes and challenges of the IRT system in an ongoing FIH trial
a. What in IRT systems is redundant from a site perspective?
b. What processes are helping or hindering them?
c. What is IRT’s role in making things easier for sites?
i. Support sites want and need from sponsors and vendors.
b. What are the wants and needs with regards to data exchange?
- Igor Druker - Director, IRT & Clinical Supply Systems, Biohaven Pharmaceuticals
- Jason Williams - Senior Manager – Clinical Systems, Takeda
- Jimmy Bechtel - Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)
d. What do sponsors mean when they say they want a full flexible system?
e. What are the systems they truly want to integrate?
i. i.e. web services, DCTs etc.
f. When it comes to flexibility and integration what are people working towards – better site experience? Quicker protocol amendments? Etc?
g. What role does the ability to be agile as a company play in this?
h. What new systems are on the horizon?
i. What, if anything, is the difference between data integration and data transfer?
j. Can we imagine a world where the IRT functionality isn’t the centre of the universe, but rather it’s integrated in other core technologies at clinical sites? The “big IRT” companies will say no, but the smaller ones are already doing it with much success.
- Jon Paras - Senior Vice President, IRT Strategy, YPrime
a. Value and examples of where AI is being applies in IRT/ Clinical Supply
b. How is AI being integrated into systems?
c. Are there certain applications which are better than others i.e. forecasting shipping dates to save costs?
d. What are the barriers to use i.e. training od staff to use technology etc.
e. Cross functional team accountability
f. Authenticity
g. Data outliers
h. AI and recruitment
i. AI guidance boards
j. Simulated AI patient trainingk. AI outcomes, verifiable?l. IRT and AI interface
m. Residence risk
- Ed Suckey - Senior Manager, IRT Services, Taiho Oncology
Informa is looking for 4 speakers (vendor/sponsors or sites) to present 15-minute flash presentations on specific technologies being applied in IRT/Clinical Supply Chain, presenting data to demonstrate efficacy.
- Robotic Process Automation (RPA) - Derek Thornton, Associate Director, Clinical Systems (IRT), Amgen, USA
- DCTs and IRT - Zachary Smith, Senior Research Analyst, Tufts CSDD, USA
- Tracking & Forecasting – Maxime Derep, Senior Solutions Engineer, N-Side, Belgium
- Integration - Romayne Brecht-Golderer, Associate Director of Clinical Data Management -eClinical Technologies, IRT Oncology Program Lead, Merck, USA