Register Now - Unlocking Longitudinal Patient-Reported Outcomes: The Untapped Value of Specialty Pharmacyocking

|Podcasts|April 30, 2021

Planning Clinical Research Studies for Successful Decentralized Trials

Author(s)Elligo

This podcast will discuss: • How partnering with specialized research organizations can help identify large, diverse patient populations to facilitate clinical studies designed around the patient • How advanced study planning and communication with regulators can ensure more successful execution of decentralized and hybrid clinical trials • The importance of the patient-physician dyad in implementing successful research studies

Newsletter

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

Better Site Training Starts With Five Simple Questions

October 7th, 2026

Better Site Training Starts With Five Simple Questions

Site training effectiveness depends on readiness at first-patient-in, requiring learning-science design principles around performance focus, cognitive load reduction, progressive sequencing, and spaced retrieval practice rather than training completion metrics or content volume.

Using AI to Design Better Trials Before the First Patient Enrolls: Q&A with Claire Riches, Citeline

October 7th, 2026

Using AI to Design Better Trials Before the First Patient Enrolls: Q&A with Claire Riches, Citeline

In this Q&A, Claire Riches, VP of clinical solutions at Citeline, discusses how AI is transforming endpoint selection and protocol pressure-testing, what data inputs matter most for realistic enrollment planning, and why the tools are more accessible than most sponsors assume.

ACT Brief: FDA Transparency Roadmap, Radiopharmaceutical Trial Operations, and AI-Powered Enrollment Prediction

October 7th, 2026

ACT Brief: FDA Transparency Roadmap, Radiopharmaceutical Trial Operations, and AI-Powered Enrollment Prediction

In today's ACT Brief, we examine the FDA's multi-domain transparency priorities, why radiopharmaceutical trials need redesigned infrastructure, and how AI can make enrollment more predictable.

© photon_photo - © photon_photo - stock.adobe.com

October 6th, 2026

Beyond the Molecule: Why Radiopharmaceutical Trials Require a New Operating Model

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.

© mod - © mod - stock.adobe.com

October 6th, 2026

FDA Releases Transparency Roadmap Outlining Disclosure Priorities Across Drug Development and Regulatory Review

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.

ACT Brief: Ibogaine Trial Design Guidance, Outsourcing Model Oversight Gaps, and Kidney Disease Partnership

October 6th, 2026

ACT Brief: Ibogaine Trial Design Guidance, Outsourcing Model Oversight Gaps, and Kidney Disease Partnership

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.

© putilov_denis - © putilov_denis - stock.adobe.com

October 5th, 2026

Mixed Outsourcing Models Are Spreading. Is Sponsor Oversight Keeping Up?

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.

© JHVEPhoto - © JHVEPhoto - stock.adobe.com

October 5th, 2026

FDA Seeks Public Input on Early-Phase Clinical Trial Design for Ibogaine

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.

Trending on Applied Clinical Trials Online

FDA Releases Transparency Roadmap Outlining Disclosure Priorities Across Drug Development and Regulatory Review

FDA Seeks Public Input on Early-Phase Clinical Trial Design for Ibogaine

ACT Brief: FDA Transparency Roadmap, Radiopharmaceutical Trial Operations, and AI-Powered Enrollment Prediction

Using AI to Design Better Trials Before the First Patient Enrolls: Q&A with Claire Riches, Citeline

Operation TrialBlazer Leveraging New and Anticipated US Policy Changes in Early Development