Newsletter | December 20, 2023

12.20.23 -- Site Selection And Design Tips For NDDs

DECENTRALIZED TRIALS

How Can Electronic Data Capture Better Serve Decentralized Clinical Trials?

Will EDC evolve to fix its existing problems, or will a different type of DCT platform (or single platform model) replace pick-and-pull, add-and-subtract modules of clinical trial technology?

Optimizing Technologies For Decentralized And Hybrid Clinical Trials

Examine several considerations when selecting a technology platform that can create operational efficiencies, reduce site burdens, and ensure accurate data collection throughout a clinical trial.

Fully Remote, Hybrid, Or Flexible Hybrid Decentralized Trials?

Explore the benefits of DCTs compared to traditional trials and review relevant examples and guidance on selecting the most suitable type of remote trial for a specific study.

How DCT DNA Became Standard In Modern Clinical Trials

See how the core features of DCTs have become the new default clinical trial practices for a variety of therapeutic areas, almost four years after the 2020 pandemic brought about their rise.

Mobile Research Units Enable Large-Volume Screenings

Learn how recruitment and screening of potential patients was made possible for a Phase 3, adult patient, clinical trial by utilizing MRUs to screen large volumes of patients at community events.

TRIAL MANAGEMENT

Trial Site Selection And Design Insights For Neurodegenerative Diseases

Amylyx’s head of global clinical development, Lahar Mehta, MD, talks multi-stakeholder trial design, purposeful site selection, caregiver burden, and the benefits of an open label extension (OLE), among other contributing factors.

The Annual Clinical Trials Roundup

Delve into in-depth analyses of key diseases, players, and geographies influencing the pharmaceutical industry through an overview of Phase 1-3 clinical trials initiated in 2022 across all therapeutic areas.

Overcoming Financial Toxicity In Oncology Clinical Trials

Discover why financial toxicity has historically plagued oncology research, what the industry can do to remove these impediments, and what important advocacy work is being conducted right now.

Rethinking "Next-Generation" Drug Development Strategies

Experts in trial design and artificial intelligence discuss innovative trial designs that combine the best of biopharma and technology to bring value to the patient.

Navigating The Biotech Landscape Amidst COVID-19 And Beyond

Access comprehensive insights and analysis for a deeper understanding of the biotech landscape, including optimism and challenges felt throughout 2023 and what the future could hold.

Clinical Trial Start-Up: Insights From The Industry

Uncover key survey findings gleaned from the perspectives of over 500 clinical researchers regarding technological trends and recommendations for enhancing the overall site experience.

The Ultimate Guide To Sample Management For Research Sites

This comprehensive guide empowers medical researchers to ensure the availability of critical lab samples, minimize errors, and enhance data integrity.

Secrets To A Collaborative Model To Improve TMF Management

Joanne Malia of Regeneron and Janice Cassamajor of Phlexglobal share a blueprint for a partnering model producing measurable benefits, including improved TMF quality, completeness, and timeliness.

A Smart Solution To Clinical Supply Management

Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.

Shorten The Path: From Discovery To Approval Of Novel Therapies

Unearth how a trial design solution was able to utilize historical trial data and real-life examples across different indications throughout the clinical development process in five case studies.

Let’s Take On Rare Disease Research Together

Learn how significant experience with natural history studies, precision medicine, and real-world data planning, trial design, and regulatory strategy can guide rare disease product development.

Clinical Trial Label Services

Examine how printing labels with speed, efficiency, reliability, and accuracy can help ensure clinical trial timeline accuracy and improve the potential for successful NDAs.

EVENTS

Global Pharmacovigilance And Risk Management Strategies Conference

Baltimore Marriott Waterfront | February 5, 2024, 7:00 a.m. — February 7, 2024, 6:00 p.m. 
DIA's Global Pharmacovigilance and Risk Management Strategies Conference is a neutral event developed by regulators and industry experts discussing the updates, opportunities, and challenges alongside fresh problem-solving strategies that matter most to safety professionals. Secure your early bird rate today!

CHOOSE YOUR OWN ADVENTURE

You're receiving the Tuesday edition of the Clinical Leader newsletter, focusing on Clinical Trial TechnologyTo make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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