Newsletter | May 1, 2024

05.01.24 -- Seeking Clarity With DCT Guidance

DECENTRALIZED TRIALS

Seeking Clarity With DCT Guidance

Sanofi's Merissa Govender, CTTI's Lindsay Kehoe, and Bayer's Aneta Woroniecka-Osio recently joined folks at Clinical Leader Live for the session Last Year’s DCT Is Today’s Clinical Trial. In this snippet, Kehoe covers topics such as the ICH E6(R3) guidance and its annex for DCTs, the use of RWD, and connecting with regulators.

Navigating Wearable Integration: Key Operational Considerations

Explore wearable devices' transformative potential and innovative capabilities for data collection, patient monitoring, and endpoint measurement.

IRT And Direct-To-Patient Trials

Want to know more about the growth and expansion of IRT in the decentralized trial space? Witness how IRT is being used to support direct-to-patient delivery in this hybrid trial case study.

TRIAL MANAGEMENT

Mission: Remission — Patient Need Informs J&J’s Ulcerative Colitis Trial

J&J Global Therapeutic Area Head, Immunology, David M. Lee, MD, Ph.D., talks about the progression from treating PsO and PsA to UC, the importance of integrating patient needs into the trial’s design, and the quest for a durable treatment that lends itself to total remission.

The Complexities Of Early Phase Ophthalmic Drug Development

From prototype formulation through preclinical testing, early phase clinical and manufacturing and development, ophthalmic drug development presents with specific and unique complexities.

Cystic Fibrosis: Global Clinical Trial Landscape (2024)

Gain valuable insights on patient enrollment, site selection, and navigating global regulatory landscapes tailored to rare diseases, thus propelling forward CF research and treatment.

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

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