Using two recent case examples we will illustrate the challenges in developing and validating ClinROs and share lessons learned in the development of a novel ClinRO.
This webinar explores the novel uses of smartphone sensor measurement in the areas of health, wellness and clinical research and appraises the promise of these approaches in clinical trials.
How will payers assess innovative therapies which still have to prove their duration of efficacy? How do manufacturers price a drug that has the potential to cure, or confer lifelong benefit from a single administration? How will already financially stretched healthcare authorities fund patient access to these therapies?
This webinar will discuss the market access and reimbursement challenges around cell and gene therapies.
This webinar draws on experience in validating a select group of PerfO assessments in orthopaedics, an area with a strong history of performance measurement, with the intention of supporting future labelling claims. The PerfO assessments were Timed Up and Go, Stair Climbs and Repeated Chair Stands which were administered in hip fracture and elective hip and elective knee replacement patients in a multi-site study.
This webinar will explain and provide examples to illustrate the importance of cultural adaptation and the steps in the linguistic validation process. The points will be made from a linguistic as well as a regulatory perspective paying particular attention to recent developments in the COA field.
Using a case study approach, webinar participants will learn more about developing ObsROs and implementing them in clinical studies. We’ll discuss some of the key challenges faced in developing and using an ObsRO, along with potential solutions.
ICON’s Webinar Channel
A library of recorded webinars exploring topics ranging from early to late phase.
