Newsletter | March 12, 2025

03.12.25 -- For Hybrid Trials, Have Some Faith … In Sites

SPONSOR

Webinar: Inspection Readiness for Decentralized Trials: Lessons from FDA Inspection of Pivotal DCT study

DCTs enhance accessibility by reducing participant burdens like travel and costs. Join us for an overview of a study using DCTs, focusing on the central and local Principal Investigator (PI) roles. Delve into preparations for inspections, including BIMO checklist references, PI interview guidelines, record-keeping requirements, and inspection process details such as agendas, oversight, and follow-up expectations. Click here to learn more.

DECENTRALIZED TRIALS

For Hybrid Trials, Have Some Faith … In Sites

Noelle Gaskill believes the key to regulatory success with a DCT is to not force a bunch of tech onto sites, but instead, choose those that already have the needed technology and experience and then let them do what they do best – execute on the trial.

Empowering Clinical Research Sites And Sponsors In Patient-Centric Era

Strategic collaboration between trial sites and sponsors plays a critical role in fostering patient-centricity within Decentralized Clinical Trials (DCTs).

SPONSOR

The Health Equity Congress (May 5-7, Atlanta) is the premier gathering where pharma, biotech, and med device leaders unite to drive organizational transformation in health equity. Industry pioneers share data-backed strategies to enhance patient recruitment, accessibility, and community engagement. Gain critical tools to scale representation efforts, build trust, and integrate equity into corporate strategies. This one-of-a-kind event turns competitors into collaborators, accelerating sustainable health equity.

TRIAL MANAGEMENT

A Tool To Tackle The Risk Of Uninformative Trials

Uninformative trials hinder progress in clinical practice, policy decisions, and further research. Fast Data Science developed a free risk tool to help pharma companies avoid them.

Antibody-Drug Conjugates (ADCs): 'Magic Bullets' Become Reality

Cancer therapy has evolved from potent chemotherapy to targeted biological therapy, including ADCs. Learn more about ADCs’ makeup, mechanisms, and the development landscape.

Improving The Patient Experience In Clinical Research

To preserve the quality of care and build a more effective approach to trial design, a sponsor must consider their approach to patient recruitment and enrollment early and often.

A Comprehensive Guide To Study Coordination Services

Explore the critical role of study coordinators, emphasizing their expertise, strategic contributions, and the value they add to clinical research.

Ensuring The Efficacy Of Probiotic Products

Without proper handling and packaging, the efficacy of probiotics can be compromised at any point in the packaging, storage, and transportation process, impacting shelf life and effectiveness.

Why Cancer Research Centers Trust OpenClinica For Oncology Trials

See eight key reasons why leading cancer research centers rely on OpenClinica to navigate the intricacies of oncology trials and advance the field of cancer research.

Q&A With Novartis And IQVIA Study Start-Up Leaders

The industry is measuring longer cycle times between protocol approval and site activation. Experts from Novartis and IQVIA share creative solutions to combat this trend and accelerate trial timelines.

Streamlining Study Start-Up For Accelerated Drug Development

What's the secret to safely expediting study start-ups? Explore this case study showcasing how communication between team leads and their sponsor contributed to a study start-up of only 3.5 weeks.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. To 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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