Newsletter | May 24, 2024

05.24.24 -- FDA Draft Guidance Focuses On In Vivo Bioavailability, Bioequivalence Studies' Data Integrity

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How Can We Improve Clinical Trial Feasibility Processes?

Clinical Leader Live uncovers how experts work to overcome frustrations in the feasibility and site selection process for clinical trials. Hear from speakers from J&J Innovative Medicines, Takeda, and CSL Behring on ways they’ve been able to improve the feasibility assessment process. Reserve your spot today for this May 30th digital event. Registration is free thanks to the support of inSeption Group.

TRIAL MONITORING

Should You Bring Your Trial Master File In-House?

Deciding whether to bring the TMF in-house or contract with a CRO depends on the sponsor's specific needs and resources, and it's important to consider the implications beforehand.

CLINICAL DATA MANAGEMENT & ANALYTICS

FDA Draft Guidance Focuses On In Vivo Bioavailability, Bioequivalence Studies' Data

The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

Something To Believe In — AI And Accelerated Computing In Healthcare

See how the advancements in supercomputing, high-performance networking, and cloud technology are paving the way for unprecedented levels of innovation and creativity in this field.

Patient Caregiver Network Improves Post-Seizure Trial Data

Discover how a pharmaceutical CRO addressed concerns about seizure diary timing in a rare disease study, leveraging insights from Medable's Patient Community Network to optimize data collection.

One Day, We Won’t Need Placebos

Embrace the future of clinical research by recognizing the limitations of traditional double-blind trials and exploring the transformative potential of real-world evidence (RWE).

Introduction To Signals Clinical

Watch to learn about an end-to-end clinical data science platform designed to streamline the rapid generation of deep insights from clinical trial data, enabling efficient delivery of crucial analyses.

A Multi-Layered Approach to Clinical Data Management

Built for clinical data management professionals, our data quality management workbench ensures data quality and facilitates data management activities through AI and automation.

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You're receiving the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial Monitoring. 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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