How a cloud-based SSU Solution with a SaaS-based platform manages the complexities of study activation.
While many vendors are claiming agile IRT capabilities, it is important to dig deeply and examine these claims – as well as a company’s proven ability to provide predictable, consistent delivery of project timelines and quality.
Implementing eSource can mean operating differently from the norm, with potentially an initial layer of complexity before things become simpler.
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.
A summary of the clinical relevance of RNA-Seq as well as when and how to use gene expression profiling for biomarker discovery for immunotherapy trials.
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.
Immune repertoire profiling provides better outcomes for immuno-oncology development programs .
This whitepaper offers a résumé of regulations under which eConsent solutions and vendors may fall and, more importantly, discusses the practical implications of those regulations for vendors and those responsible for designing and executing research plans.
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