Newsletter | November 15, 2024

11.15.24 -- FDA Issues Bioresearch Monitoring Technical Specifications Document

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CLINICAL DATA MANAGEMENT

Alexion Rethinks Diversity Metrics And Why Race Alone Isn't Enough

Guest Column | By Adrian Kielhorn, Alexion, AstraZeneca Rare Disease

Clinical research does not adequately measure diversity, argues Alexion's Adrian Kielhorn. An expert in health economics and outcomes research (HEOR), Kielhorn suggests a more nuanced way of looking at diversity.

Showcasing Advances In CAR-T Research At The ASH Annual Meeting

Poster | Medidata AI

Take a look at three research posters presented at the 65th American Society of Hematology (ASH) annual meeting, emphasizing the impact of academic-industry collaborations on CAR-T therapy.

Standardizing Data Collection With CDASH

Article | Mednet

Understand how the Clinical Data Acquisition Standards Harmonization works to support the integration of research into the clinical workflow.

CLINICAL DATA MANAGEMENT - SOLUTIONS

Introducing TrialKit AI For Advanced Analytics And Reporting

Video | Crucial Data Solutions

Check out this workshop introduction to TrialKit AI’s dynamic analytics and reporting capabilities.

Advarra Cloud

Brochure | Advarra

Seamlessly incorporate user-friendly interfaces and industry-leading practices to ensure a sustainable and cost-effective solution tailored to the dynamic landscape of business and regulatory demands.

TRIAL MONITORING

FDA Issues Bioresearch Monitoring Technical Specifications Document To Help You Organize Your Submission

Guest Column | By Peter H. Calcott, Ph.D., Calcott Consulting LLC

The FDA has issued the latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document: version 3.1. This version will likely be in place for a significant length of time as a road map for constructing this part of the NDA or BLA that you submit.

483 Issues To Sites – Indicators Of Sponsor Oversight Effectiveness

Article | By Lyn Agostinelli, Halloran Consulting

Explore how effective oversight is critical for companies addressing Form 483 observations identified during clinical study site regulatory inspections.

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