Partnerships in Clinical Trials Europe

Meet ERT representatives and attend these sessions for current information on improving clinical research:

“BYOD: A Game-Changer for Sponsors, Sites and Patients”

Wednesday, November 28 at 3:00 pm

In this discussion, ERT’s Chris Watson, PhD shares BYOD and flexible provisioning success stories, as well as demonstrate why sponsors need to incorporate this approach into study protocols and post-marketing evidence programs:

  • Know what’s really meant by ‘BYOD’ and ‘flexible provisioning’
  • Understand how FDA, EMA and regional regulators view BYOD data
  • See how BYOD has moved beyond patient smartphones to include site tablets and workstations
  • Preview how exploratory endpoints and real world evidence may include wearables and even voice-assisted technology such as Amazon Alexa

 

“Beyond Risk-based Monitoring: Employing Risk-based Management”

Wednesday, November 28 at 12:30 pm

In this discussion, ERT’s Jenny Lohan will share practical guidance on how trial leaders can proactively manage performance at the study, site and trial portfolio levels. Discussion highlights include:

  • Exploring process, resource, and technology challenges in implementing risk-based management (RBM)
  • Overcoming challenges in data source variability, data latency and data aggregation
  • Moving beyond RBM: Incorporating study start-up metrics, milestone tracking and other KPIs
  • Complying with ICH E6 guidance: Sponsor / CRO roles in risk-based management and oversight
  • Finding the best model and solution for your organization: The value of pilots and proofs of concept (POCs)

 

FUTURE DEBATE: What single activity will change our industry the most by 2030?

Thursday, November 29 at 12:20 pm   

  • Patient Led Movement – Mobile
  • Role of the Investigator?
  • Mobile Health
  • Regulatory Changes
  • Patient Centric Approaches
  • Voice Assistant Technologies (Chris Watson, Director of Product Strategy, ERT)
    • Using voice assistant technology in clinical trials, e.g., data capture, patient engagement/support
    • Reviewing examples from proof of concept work ERT has completed
    • Navigating regulatory requirements

Not going to the conference? Click here to learn how ERT can help you minimize the uncertainties and risks that could cause delays and increase trial costs.