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 First in Human trial
B. Case Study on someone that has successfully done this
C. How do we make this the norm and not the exception?
a. Preventing program errors
b. Verifying configuration
c. Testing to minimise risk of error.
d. How do you balance the need for speed and the need for validation and verification?
e. Quality, quality, quality!
f. Impact of automation and AI on testing
g. Impact of ‘shift left’ on the testing gates
h. Best practises for finding errors early
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?
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.
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
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
- E-technologies
- AI
- Tracking & Forecasting – N-Side
- Integration - Romayne Brecht-Golderer, Associate Director of Clinical Data Management -eClinical Technologies, IRT Oncology Program Lead, Merck, USA
- Site Experience