Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.
Why you should prepare now even with nearly a year remaining.
How a CRO is leveraging the eClinical versatility necessary to succeed in a broad array of studies.
Since the launch of myTI—TransPerfect’s mobile experience for the Trial Interactive eTMF—I have heard rave reviews from clinical operations leaders and CRAs. The advantages of mobile technology for clinical operations are generating a lot of excitement, and rightfully so. In my collaboration with study teams during the development, release, and ongoing evolution of myTI, we encountered many thematic pain points that were ripe for a mobile solution.
Late Phase Research in the Life Sciences segment is undergoing a rapid transformation due to the digitalisation of healthcare and the greater availability of, and access to, Real World Data (RWD). This transformation is arriving not a moment too soon, given the changes anticipated from the Twenty-first Century Cures Act, EMA’s Adaptive Pathways approach, and the increased demand for Real World Evidence (RWE) generated from these RWD. In addition to supporting regulatory decisions, RWE is playing an ever expanding role in developing the product value propositions that are driving reimbursement decisions globally.
Direction from a solution provider with expertise in forecasting, packaging, labeling and distribution along with services of an IRT provider solves drug shortage challenge.
Three success factors for leaner operations.
Pharma companies and CROs are recognizing the need for focused electronic feasibility solutions to resolve challenges with processes managed in Excel trackers.
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