Labs Articles

Preparing Specialty Lab Data for FDA Submission in the New Regulatory Environment

Mar 12, 2018

By Jared Kohler, PhD, Angela Quigley, Tobias Guennel, PhD

Biomarker and specialty lab data are increasingly being incorporated in FDA submissions given the robust insights they provide on key clinical objectives, including pharmacological effects, and drug safety and effectiveness.

In-Home Trial Supply Challenges

Sep 19, 2017

By Glenda Womack

CRO's and sponsors are taking clinical trials to homes. These in-home trials can address participation issues and provide added convenience plus support for patients, but they also come with their own set of risks.

Meeting the Clinical Supply Challenge with IRT

Sep 14, 2017

By Stefan Dürr

Managing clinical trial supply is not easy for the pharmaceutical industry between drug overages and right medical distribution. However, this is an important topic for sponsors to consider because the right strategy can help save money and reduce unnecessary spending.

Afib Detection: True or False Due to Bad Quality Recordings

Aug 01, 2017

By Luc Dekie

This article discusses atrial fibrillation (Afib) detection and ECG recordings of the arrhythmia.

High Quality ECG Recording Assurance

Jul 13, 2017

By Luc Dekie

This article discusses the importance of good patient preparation, lead hook-up, and the quality checks that can be performed to ascertain that an ECG is of good quality.

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