In today's ACT Brief, we examine what patient-site relationships need beyond easier technology, how to build defensible rare disease evidence from scratch, and how real-world data and AI improve enrollment screening accuracy.
|Articles|June 15, 2015
CRO PROMETRIKA Expands Use of Medidata’s Cloud-Based Platform
Medidata, a global provider of cloud-based solutions for clinical research in life sciences, announced that PROMETRIKA, LLC, a full-service clinical research organization.
Advertisement
Medidata, a global provider of cloud-based solutions for clinical research in life sciences, announced that PROMETRIKA, LLC, a full-service clinical research organization (CRO) supporting the biopharmaceutical and medical device industries, has increased its adoption of the Medidata Clinical Cloud® platform. A longstanding Medidata partner, PROMETRIKA will now leverage Medidata’s solution for patient-centric data capture and management (Medidata Patient Cloud®), which will enable them to capture current patient data without paper-based forms.
Advertisement
Related to this article
In rare disease drug development where no registry or natural history dataset exists, real-world evidence quality depends on treating evidence engineering as a design-stage decision, defining intended regulatory use and standardizing endpoints, harmonization, and data provenance upfront rather than reconciling gaps after collection.
In this Q&A, Andrea Valente, CEO of uMotif, discusses what it takes to build genuine trust between patients and sites, why making technology easier to use isn't the same as making patient-site interaction more effective, and where the industry is still falling short in its push toward patient-centered trial design.
In today's ACT Brief, we examine why defensible trial data depends on traceability and platform ownership, what CGT site readiness requires as therapy moves to community care, and why data harmonization is AI's primary bottleneck.
Cell and gene therapy access expands into community care settings only when operational coordination, site readiness, and supply chain standardization become first-order priorities equivalent to manufacturing capacity, requiring standardized processes, digital integration, and distributed logistics networks.
In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Cecilia Xi, PhD, VP of clinical and scientific affairs at Vivalink, about why defensible trial data depends on traceability, platform ownership, and device strategy long after a study ends.
In today's ACT Brief, we examine understanding the patient journey from end to end, whether decentralization reduces site burden or just shifts it, and why nine European drugmakers are sounding urgent alarms.
Decentralized trial models have demonstrated real gains in enrollment performance and patient access, but operational switching costs, fragmented technology stacks, and unresolved gaps in the patient-site relationship raise a question the industry has been slow to confront directly.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
When There’s No Registry: Building Rare Disease Evidence That Supports Regulatory Scrutiny
2
ACT Brief: Patient-Site Trust Barriers, Rare Disease Evidence Without Registry, and RWD Enrollment Accuracy
3
Trust, Technology, and the Patient-Site Relationship: Q&A with Andrea Valente, uMotif
4
ACT Brief: Data Provenance and Device Strategy, Cell-Gene Therapy Site Readiness, and Data Harmonization Bottleneck
5