Newsletter | November 11, 2019

11.11.19 -- BERG Invests In Biology And AI To Drive New Cures

Featured Editorial
BERG Invests In Biology And AI To Drive New Cures
By Ed Miseta, chief editor, Clinical Leader

A 2017 report published by Deloitte concluded that much of the current stagnation in drug discovery is due to the industry’s limited understanding of the fundamental molecular mechanisms of disease. Dr. Niven Narain, co-founder, president, and CEO of BERG, believes getting a handle on those mechanisms is vital to producing more effective therapies in a shorter amount of time.

The EU Qualified Person (QP) Demystified: Fool-Proofing Your EU Phase 1 Trial
By Enith Morillo and Azeem Shan

For U.S. sponsors planning to conduct clinical trials in the EU, qualified persons (QPs) may at times be perceived as a challenge to overcome, because their role and responsibilities are not fully understood. Conversely, part of the QP’s role is to support clinical trials in the EU by certifying compliant clinical trial materials while protecting public health.

Industry Insights
Your 5 Questions About Enrollment Assistants Answered
Article | By Mark Summers, WCG

Enrollment assistants ease site burden and increase patient engagement. Following are answers to five common questions about the use of this on-the-ground recruitment support.

Navigating The Global Virtual Trials Regulatory Landscape
Article | By Amber Corbin, IQVIA Virtual Trials

Sponsors must be cognizant of the regulatory landscape — which countries or regulatory agencies support these trials, and which are still forming opinions — before launching a complex virtual research strategy involving participants in numerous countries. Learn how sponsors can steer through an evolving landscape, track local attitudes, and plan trials accordingly.

Partnering For Quality, Innovation And Expertise: Conversations With Industry Pharma Leaders
Article | By Jennifer Aquino, Cenduit LLC

Jennifer Aquino, chief operating officer at Cenduit recently had the opportunity to visit with several clients and opinion leaders on a year-end “listening tour” to discuss their issues and goals for 2019 and beyond. Read what they had to say regarding the industry’s challenges and opportunities.

Putting CDISC Standards To Work
White Paper | By Jon Roth and Mark Vieder, Biorasi

Read how by integrating CDISC standards at the very beginning of a clinical trial, research organizations can leverage powerful analysis tools to cut through much of the tedious, time-consuming, and expensive manual work typically associated with collecting, cleaning, analyzing, quality controlling, and reporting clinical study data.

The Complete EDC Buyer’s Guide: What Should You Be Looking For?
White Paper | Medrio

Navigate the process of EDC vendor selection and make a better-informed purchase decision on this key technology for clinical research.

Veeva 2019 Unified Clinical Operations Survey: Annual CRO Report
White Paper | Veeva Systems, Inc.

This global research examines the drivers, barriers, and benefits of a unified clinical operating model from a CRO perspective. Findings show CROs are leading the adoption of modern clinical applications to increase efficiency, enhance collaboration, and improve trial performance.

Finding Trial Summaries Online A Plus For Patients
Article | TrialScope

For patients, finding a clinical trial can be a challenge in and of itself. So imagine the frustration patients feel when they can’t find — or understand — results of a study in which they have participated.

Clinical Supply Optimization: Building Trust To Ensure Patient Safety
Case Study | Thermo Fisher Scientific

Fisher Clinical Services was contacted in early 2013 by a virtual biotech that had a set of unique challenges. With just one compound in the pipeline, the company was in trouble because its previous vendor made drug supply errors that compromised patient safety in Phase II. Not only was the clinical team navigating the ethics investigation triggered by this violation of trust, the legal team was fending off lawsuits from investors.

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