Newsletter | August 28, 2025

08.28.25 -- Synthetic Control Arms: When Data Stands In For Patients

SPONSOR

Revolutionize your approach to clinical trials at DPHARM: Disruptive Innovations to Modernize Clinical Research, taking place September 16–17, 2025, in Philadelphia. This conference showcases cutting-edge strategies and technologies designed to reduce patient and site burden, streamline operations, improve data quality, and accelerate access to therapies.

FEATURED EDITORIAL

Synthetic Control Arms: When Data Stands In For Patients

Synthetic control arms replace traditional control groups with carefully matched historical or real-world data, offering an option for rare diseases, ethical constraints, or when high-quality datasets exist. They can speed access to treatments, but success depends on rigorous data matching, upfront planning, and early regulatory engagement.

INDUSTRY INSIGHTS

FDA's Vision On PRO Collection For RWE

In this presentation, a distinguished panel of experts illuminates the crucial role of patient-reported outcomes (PROs) in shaping regulatory decisions and drug development strategies.

Regulatory Opportunities For Decentralized Clinical Trials

Project SHASTA, a pioneering effort to measure the benefits of decentralized trial elements, reveals significant regulatory opportunities that could shape the future of clinical research.

The Strategic Advantage Of eCOA And IRT

The future lies in unified, interoperable eCOA–IRT solutions that streamline operations, improve data integrity, and enhance patient and site experience.

Breaking Through Barriers With Integrated Trial Optimization

In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.

3 IRT Tactics Being Used To Streamline Supply Logistics

Shipping and storing leading-edge therapeutics require complex logistics, but enhanced automation and process simplification ensure that sites and patients have the drugs they need when they need them.

How We Used Intelligent Automation to Transform Vendor Selection

Discover how your small biotech can achieve faster timelines, improved cost control, and more strategic, transparent choices with a platform leveraging intelligent automation.

Hope In The Dark: Value In Alzheimer's Disease Research And Treatment

The May/June 2025 issue of Value & Outcomes Spotlight explores the health economics and outcomes research (HEOR) and its contribution to research and treatment of Alzheimer’s disease.

What Is Electronic Data Capture And How Does It Simplify Data Management?

As EDC systems continue to evolve, they streamline workflows, enhance data security, and improve patient outcomes.

Study Activation Survey Report Sheds Light On Trials

Utilize this report to enhance the overall site experience during clinical trial operations, improve site experiences, expedite study initiation, and advance clinical development.