It’s All About the Data—Standardization, Technology, and Requirements

In this ISSUE

The Turning Point for Clinical Research; Global Data Standardization

CTMS: What You Should Know

Real-World Evidence Studies

Regulatory Authorities

FDA Will Miss Gottlieb's Leadership

Gottlieb's tenure included record new drug approvals and steps taken to curb opioid abuse.
... /Read more/

RBM Case Studies: How Artificial Intelligence and Machine Learning with Advanced Analytics are driving new levels of patient safety and study quality
Thursday, March 28, 2019 11am EDT

Risk-Based Monitoring

Weighing the Benefits of RBM Implementation

Case study demonstrates how one global mid-sized sponsor is testing the RBM waters.
... /Read more/

Calendar

/ IRT Europe 4/16–4/17 /

/ Clinical Research as a Care Option 4/29–4/30 /

/ Clinical Trial Budgeting and Forecasting 4/30–5/1 /

/ 5^th Annual Endpoint Adjudication 5/1–5/2 /

/ MDR Workshop — Transitioning to the EU MDR and Managing Legacy Devices 5/15 /

Fast, Focused Medical Data Review – Use Cases by a Medical Monitor
Wednesday, March 27, 2019 at 11am EDT| 8am PDT| 3pm GMT| 4pm CET

Data Systems

Can Data from EHR Systems Be Trusted in a Trial Setting?

An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply with regulatory requirements.
... /Read more/

Minimizing the Impact of Human Error, Subjectivity, and Labor Costs
The Application of Digital Pathology in Clinical Trials
Tuesday, March 19, 2019 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET

Clinical Trial Monitoring

The Risk Based Monitoring Plan

Sponsors and CROs are looking into implementation of a Risk-Based Monitoring approach to their clinical trials to achieve the objectives related to enhanced data quality, better monitoring of patient safety, and creating efficiencies in overall operations.
... /Read more/

Supply Chain

A New Approach to Temperature Monitoring in a Changing Clinical Supply Chain Environment

Examining the implications of shipping temperature-sensitive clinical supplies in an evolving clinical supply chain, including shipments direct to patient homes (DTP) and the need for temperature monitoring thereof.
... /Read more/

Ask the editor

Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com

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Todd Baker
Group Publisher
todd.baker@ubm.com

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