|Articles|October 10, 2005

Applied Clinical Trials-10-11-2005
Volume 0
Issue 0

Welcome

Welcome to the 12th Annual Applied Clinical Trials European Summit E-Show Daily presented by ACT magazine. This special show daily is designed to give you a recap and highlights of the seminar proceedings and plenary sessions from the conference floor. The conference covered the regulatory climate in Europe and electronic data capture.

Welcome to the 12th Annual Applied Clinical Trials European Summit E-Show Daily presented by ACT magazine.

This special show daily is designed to give you a recap and highlights of the seminar proceedings and plenary sessions from the conference floor. The conference covered the regulatory climate in Europe and electronic data capture.

Articles in this issue

almost 21 years ago

Article

ICTI Software Used in Major Government Study

almost 21 years ago

Article

Special Lecture, Networking Dinner, 5 October 2005: Industry Consolidation and the Emerging Shape of R&D

almost 21 years ago

Article

MEDIDATA SOLUTIONS AND CHINESE STATE FOOD & DRUG ADMINISTRATION HOST E-CLINICAL SEMINAR IN BEIJING

almost 21 years ago

Article

Seen and Heard

almost 21 years ago

Article

How to Make Progress with Electronic Data Capture, Current and Future Status of EDC in Europe

almost 21 years ago

Article

Successful Development of Vaccines

almost 21 years ago

Article

eResearchTechnology Announces Record-Breaking $32 Million In Third Quarter Awards for Cardiac Safety Monitoring Services and EDC/Clinical Data Technology

almost 21 years ago

Article

Pharmacovigilance in the EU and under the Clinical Trials Directive

almost 21 years ago

Article

etrials Adds Three New Trials for Top Ten Pharmaceutical Clients Company Supplies Patient Diary Technology to Over 4,000 New Patients

almost 21 years ago

Article

Updates on the new French health law and it's impact on clinical trials.

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

Related to this article

September 25th, 2026

Sponsor Oversight in an Outsourced Trial: What Good Looks Like and How to Evidence It

Sponsor oversight of outsourced CRO work is often robust in practice but fails inspection because oversight decisions are fragmented across systems and lack an audit trail, requiring sponsors to document oversight as a connected operating system with clear decision records, escalation pathways, and issue resolution from start to finish.

September 25th, 2026

How AI Is Changing Endpoint Selection Before a Trial Even Starts

In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains how AI is expanding endpoint selection beyond the bounded experience of a single sponsor team—and surfacing options that traditional design thinking might never have considered.

September 25th, 2026

ACT Brief: Patient-Site Trust Barriers, Rare Disease Evidence Without Registry, and RWD Enrollment Accuracy

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.

© putilov_denis - © putilov_denis - stock.adobe.com

September 24th, 2026

When There’s No Registry: Building Rare Disease Evidence That Supports Regulatory Scrutiny

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.

September 24th, 2026

Trust, Technology, and the Patient-Site Relationship: Q&A with Andrea Valente, uMotif

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.

September 24th, 2026

ACT Brief: Data Provenance and Device Strategy, Cell-Gene Therapy Site Readiness, and Data Harmonization Bottleneck

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.

September 23rd, 2026

Clinical Site Readiness for Cell and Gene Therapies: Operational and Supply Chain Challenges as they Scale and as they Expand into the Community Care Setting

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.

September 23rd, 2026

Beyond Compliance: Vivalink's Cecilia Xi, PhD, on Data Provenance and Sustainable Device Strategy in Clinical Trials

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.

Welcome

Articles in this issue

Related to this article

Trending on Applied Clinical Trials Online

When There’s No Registry: Building Rare Disease Evidence That Supports Regulatory Scrutiny

Sponsor Oversight in an Outsourced Trial: What Good Looks Like and How to Evidence It

How to recruit specialty volunteer populations for early-phase clinical research: 5 things to ask when choosing a CRO partner

How AI Is Changing Endpoint Selection Before a Trial Even Starts

Beyond Compliance: Vivalink's Cecilia Xi, PhD, on Data Provenance and Sustainable Device Strategy in Clinical Trials