Newsletter | June 27, 2019

06.27.19 -- Right Design, Right Data, Right Decision: Advancing Development With Analytical Solutions

2018 vs. 2010 FDA Draft Guidance For Industry On Adaptive Designs For Clinical Trials Of Drugs And Biologics

In September 2018, the FDA issued a new draft guidance for industry — Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance. Here, we summarize the differences between the two documents and highlight any significant new elements introduced in the most recent material.

Ensuring Robust ePRO Implementation: Factors For Success

Electronic patient-reported outcomes (ePRO) are essentially a validated set of questionnaires that are given to patients to assess subjective experiences. With many trials now incorporating ePRO, this article examines three critical considerations for sponsors when implementing ePRO solutions into their trials.

Opening The Black Box: Moving To Explainable AI

For the biopharma industries specifically, artificial intelligence (AI) represents an opportunity to avert the R&D productivity crisis with paradigm-shifting applications such as in-silico drug design, prediction of trial risks, and big data analytics. This article discusses how pharma needs to address the opacity of AI to ensure trust and credibility with all stakeholders.

Assuring Outsourcing Obligations With Specialist Data Management Oversight

Learn how specialist CROs can add value and streamline processes by providing oversight of data management services delivered by another CRO. This model helps to fulfill essential regulatory obligations for biopharma companies that may lack their own internal oversight resources.

From Trial Design To CDISC Submission

CRO manages multiple, complex statistical analysis deliverables for a program of studies, CDISC compliant outputs, and data pooling for NDA submission to the FDA with minimal sponsor oversight.