|Articles|July 1, 2011

Applied Clinical Trials-07-01-2011
Volume 20
Issue 7

Applied Clinical Trials Digital Edition - July 2011

CRO/SPONSOR : Personalized Medicine Development - Role of CROs TRIAL DESIGN : Eye Movements Help Determine Side Effect Profiles SUBJECT RECRUITMENT : Connecting Type 2 Diabetics to Clinical Trials INFORMATION TECHNOLOGY : Cloud Computing Brings Efficiencies to Life Sciences Also in this issue : Biosimilars Development, Funding in Europe, Transforming R&D, Subject Protection in India

External Link - article-800737.pdf

Articles in this issue

about 15 years ago

Article

Recruiting Diabetes Subjects

about 15 years ago

Article

Eyes Play a Focal Role in Research

about 15 years ago

Article

Fighting for Territory and Funding in Europe

about 15 years ago

Article

Cloud Computing Efficiency

about 15 years ago

Article

Best Practice for Clinical Monitoring

about 15 years ago

Article

Personalized Medicine Development

about 15 years ago

Article

Italian Regulator Prepares for Europe's Top Job

about 15 years ago

Article

Value of Time and Money

about 15 years ago

Article

Transforming R&D Through Open Innovation

about 15 years ago

Article

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

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FDA Opens Applications for Expedited IND Pilot Designed to Accelerate First-in-Human Trial Timelines

The pilot pairs drug sponsors with qualified research institutions to compress the path from drug identification to first-in-human study through rolling submission review and earlier coordination of institutional review board and site activation activities.

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Benchmarking Study Finds Clinical Trial Performance Is Shaped by Operating Model Design, Not Sourcing Strategy

A Syneos Health-announced study from Tufts Center for the Study of Drug Development finds no single sourcing model consistently outperforms others, pointing instead to vendor coordination, governance, and fit-for-purpose design as the real performance drivers.

This article summarizes the FDA's four-part Patient-Focused Drug Development (PFDD) guidance series, the parallel mechanisms emerging in the European Union and the United Kingdom, the operational gaps sponsors most often encounter, and the areas in which large-scale, structured, patient-reported real-world data can and cannot contribute to a PFDD-aligned research plan. Credit: Stock.Adobe.com/Bordinthorn.

September 16th, 2026

Operationalizing the Patient Voice: Converging U.S., EU, and UK Requirements and the Role of Real-World Patient-Reported Data

Regulatory expectations for patient input in drug development have shifted from aspiration to documented methodology across three major jurisdictions.

September 16th, 2026

The Human Side of Clinical Trials: How Measuring Readiness at Training Predicts Trial Risk Before It Shows Up in the Data

This episode of The Human Side of Clinical Trials, hosted by Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., explores why training completion metrics like attendance and quiz scores fail to capture true study readiness, and how measuring both competence and confidence can reveal trial risks before enrollment even begins.

September 16th, 2026

How Clinical Teams Can Build Real Trust With Patient Advocacy Organizations

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, outlines what it takes to move beyond transactional engagement and treat patient advocacy organizations as long-term partners in the science and the care.

September 16th, 2026

ACT Brief: Epilepsy Trial Feasibility and Family Realities, CRO Partnerships and Strategic Value, and Cortisol and GLP-1 Response

In today's ACT Brief, we examine what families with rare epilepsy teach about trial feasibility, how preclinical CRO partnerships are evolving beyond transactional services, and why cortisol dysregulation limits GLP-1 effectiveness in diabetes.

Preclinical CROs are evolving from transactional vendors into strategic partners, with trust, talent, AI, and shared accountability driving value in 2026. Credit: Stock.Adobe.com/Gorodenkoff

September 15th, 2026

The Evolution of Preclinical CRO Strategic Partnerships: From Transactional Services to Value-Driven Ecosystems in 2026

As the life sciences industry continues to evolve, the ability to effectively manage and leverage preclinical CRO partnerships is set to become a defining characteristic of successful biopharma companies.

September 15th, 2026

What the Epilepsy Community Has Taught Us About Trial Feasibility

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, shares what she has learned firsthand from families living with Dravet syndrome and CDKL5 deficiency disorder about what makes trial participation possible—and what makes it not.

Applied Clinical Trials Digital Edition - July 2011

Articles in this issue

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