Newsletter | September 9, 2019

09.09.19 -- How To Conduct Better GCP Audits

Featured Editorial
What Do Sponsors And CROs Think About Technology Use In Trials?
By Ed Miseta, chief editor, Clinical Leader

Each year, The Avoca Group surveys industry professionals to understand trends in clinical development. For one of its most recent surveys, Avoca examined what sponsors and CROs think about innovation and the use of technology in clinical trials.

How To Conduct Better GCP Audits (Even When You Feel Like An Imposter)
By Iain Pulley, director, Closed Loop Quality Ltd

How many of us drive to work every day? How many of us know the route so instinctively that we no longer think about where we have to go? It’s easy, right?

Industry Insights
Demystifying IRT Terminology
Article | By Bryan Clayton, YPrime

Bryan Clayton, vice president, strategic solutions, YPrime recently presented a webinar on IRT technology. This article recaps the discussion on IRT terminology, SDLC methodologies, and how different approaches can save time, risk, and cost.

How Services Marketers Can Own Their Performance Measures
Article | By Kevin Olson, Industry Standard Research

Service marketers can take control of their marketing performance by implementing credible marketing effectiveness measures and creating their own narrative.

Embracing Innovative Designs In Early-Phase Oncology Trials
White Paper | IQVIA Biotech

Advancements in science and technology are driving accelerated timelines and creative pathways for oncology drug development. Oncology sponsors and regulators seek new ways to efficiently move promising therapies from the clinic to approval — embracing a streamlined path that bypasses the traditional development paradigm of standalone sequential Phase I/II/III trials.

Califf: Digitization Will Return Humanity To Medicine
Podcast | DIA

“Digitization is something that is happening to everything that we do. It’s being called the fourth industrial revolution,” explains Dr. Robert Califf, former FDA commissioner and vice chancellor for health data science at Duke Health. “And if we do it right, it will actually free up clinicians to spend more time directly with people and, when they become patients, with sick people, which is what we really want.”

MedTech Mindset Podcast: Data Flow With Seth Goldenberg
Podcast | Veeva Systems, Inc.

How can data flow impact speed-to-market for medtech innovators? Find out in this episode of MedTech Mindset with Seth Goldenberg of Veeva Systems.

Tackling The EU CTR Compliance Challenge
Webinar | TrialScope

Maintaining disclosure compliance is tricky enough with, but when it comes to EU CTR compliance the complexity rises to a whole new level. As a sponsor, do you find your organization “guilty” of these common errors?


The CNS Summit is the leading life sciences meeting on innovation, technology, and collaboration for clinical development. More than 750 clinical development leaders from pharma, biotech, CROs and service companies, technology companies, and research sites will participate.

Use code CL19 for a special rate at October 31 to November 3, Boca Raton, FL.

Regulatory Affairs: The IND, NDA, And Post-Marketing
October 14, 2019 | Philadelphia, PA
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