Newsletter | September 23, 2026

09.23.26 -- Overcoming Enrollment Barriers And Navigating Decentralized Trial GCP Requirements

SPONSOR

 

Webinar: Scaling Pharmacovigilance: From Clinical Development to Commercialization

Pharmacovigilance becomes more complex as biopharma companies move toward commercialization and global growth. In this webinar, Nina Lahanis draws on 30+ years of pharmaceutical experience and 16+ years in PV leadership to share practical lessons on building scalable operating models, preparing for commercial readiness, navigating technology and governance decisions, and strengthening resilience in an evolving regulatory environment. Register for actionable insights. Click here to learn more.

DECENTRALIZED TRIALS

 

CISCRP's Mobile Health Exhibit Brings Clinical Trial Education To Communities

Guest Column | By Justine Holleran and Shalome Sine, CISCRP

CISCRP shares its mobile education project brings clinical trial awareness and information directly to communities.

 

Ophthalmic Clinical Trials: Addressing Enrollment Barriers

Article | 20/20 Onsite

Ophthalmic trials lose participants at twice the rate of other studies. Point-of-need assessment delivery cuts dropout from 30% to 9% and reduces travel burden by 80.6%, protecting your endpoint data.

 

ICH E6(R3) Annex 2: Navigating Decentralized Trial GCP Requirements

White Paper | Castor

Implementing decentralized components or real-world data requires proactive alignment with updated GCP standards for data access, remote consent, and multi-stream investigator oversight.

TRIAL MANAGEMENT

 

From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development Teams

Guest Column | A conversation between Svetlana Kobina and Clinical Leader Executive Editor Abby Proch

AbbVie's Svetlana Kobina discusses how basket trials can help clinical development teams move from early clinical signals to a more disciplined strategy.

 

Cardiac Safety Assessments In Clinical Trials

E-Book | Altasciences

Assess cardiac risk with expert QT/QTc study design and execution, generating reliable data to inform decisions, reduce development risk, and keep your program moving forward.

 

AI Should Strengthen Trial Execution, Not Substitute For It

Article | TruTechnologies

Before adding AI to your workflow, strengthen your clinical foundation. Clean, real-time trial data at the point of care is essential for faster, better decisions.

 

Packaging And Labeling Support For A Global Cell Therapy Program

Case Study | Thermo Fisher Scientific

Master complex cell therapy logistics with coordinated depots, purpose-built labeling, and temperature-controlled solutions that protect product integrity.

 

Making Early Decisions In Psychiatric Drug Development

Article | CHDR

Quantitative PD measures provide objective evidence of target engagement, support dose selection, strengthen early go/no-go decisions, and help reduce development risk in psychiatric

 

Data-Driven Paths To Rare/Ultra-Rare Disease Therapy Approval

Brochure | Veristat, Inc.

Explore how integrated regulatory, statistical, and operational expertise can be applied to help sponsors navigate complex development pathways and accelerate global approvals.

 

Understanding Options In Direct-To-Patient Clinical Supply

Video | Catalent

Learn how DTP clinical supply enables participants to receive treatments in the convenience and comfort of their own homes while reducing (or eliminating) the need to travel to a clinical site.
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