Radiopharmaceutical therapy is exposing a broader challenge for clinical development: scientific innovation can advance only as fast as the infrastructure, data, and cross-functional decisions required to deliver it.
|Articles|July 21, 2015
PAREXEL Launches Next Generation Analytics
With the Perceptive MyTrials Analytics solution, clinical trial sponsors can now use a mobile-enabled, single entry-point to access predictive data analytics.
Advertisement
PAREXEL, a global biopharmaceutical services provider, launched the next generation of its Perceptive MyTrials® platform with advanced analytics capabilities. With the Perceptive MyTrials Analytics solution, clinical trial sponsors can now use a mobile-enabled, single entry-point to access predictive data analytics for multiple studies simultaneously. The solution offers real-time and aggregated analytics allowing sponsors and PAREXEL® clinical research professionals to detect key signals and trends.
Advertisement
Related to this article
A new FDA Voices post from the agency's acting chief of staff details completed milestones and upcoming priorities across complete response letter disclosure, application lifecycle transparency, new approach methodologies, labeling, and inspectional records.
In today's ACT Brief, we examine FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread faster than oversight infrastructure, and a major partnership for a rare kidney disease treatment.
Mixed FSP and FSO models are gaining ground as sponsors seek agility and resource flexibility, but the oversight infrastructure, audit trails, and accountability structures needed to run them well and survive regulatory inspection are consistently lagging behind the model itself.
A new request for information asks for comments on dose selection, safety monitoring, eligibility criteria, and oversight approaches to support the responsible development of ibogaine drug products.
In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment benefit, and why early-stage program failures signal smarter pipeline management.
Hierarchical composite endpoints analyzed through pairwise comparisons more accurately reflect multifaceted treatment benefit than time-to-first-event composites, but transparent outcome prioritization, patient involvement in ranking, and reporting of Net Treatment Benefit remain underutilized despite their importance to interpretation.
In this video interview, Claire Riches, VP of clinical solutions at Citeline, offers practical guidance for clinical operations teams beginning their AI journey—making the case that the tools are more accessible than many assume and that waiting to start is a competitive risk in itself.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
FDA Seeks Public Input on Early-Phase Clinical Trial Design for Ibogaine
2
Mixed Outsourcing Models Are Spreading. Is Sponsor Oversight Keeping Up?
3
FDA Releases Transparency Roadmap Outlining Disclosure Priorities Across Drug Development and Regulatory Review
4
ACT Brief: Ibogaine Trial Design Guidance, Outsourcing Model Oversight Gaps, and Kidney Disease Partnership
5