Newsletter | August 3, 2022

08.03.22 -- Decentralized Clinical Trials: Are We Using The Best Terminology For Patients?

Virtual Event
Featured Editorial
Industry Insights
Quality By Design: A Holistic Approach To Drug Development

While QbD evolves from good practice to agency requirement, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?

Understanding The New FDA DHT Guidance

This guide is focused on sensor-based digital health technologies, specifically study-dedicated, research-grade wearable devices.

e-book: Exploring Enhanced Clinical Collaboration In Modern eTMF Systems

This e-book examines the rising trend in compliance findings due to incomplete or poor-quality trial master file (TMF) submissions.

On The “Fast Track:” Fast Track Designations For Your 505(b)(2) Drug Development Program

One of the tenets of the FDA is to get safe and effective drugs to market as soon as possible. This blog focuses on the details of Fast Track designation (FTD) and how 505(b)(2) products can qualify for this program.

Applying Consumer Engagement Strategies To eClinical Technology

When it comes to patient engagement, the experience and technology gaps apparent in the clinical trial space have resulted in a lag for virtual technologies that offer comparable functionality to those pioneered by other sectors.

Featured Editorial
Industry Insights
Interview With CEO Jim Murphy: Budgeting And Fair Market Value

In this interview Greenphire CEO, Jim Murphy, sits down with ClinBiz founder and CEO, Debora Araujo, to discuss critical challenges related to clinical trial planning and start-up.

eCRF In Clinical Trials: Shifting To A Modern Research Paradigm

The technology researchers use to manage data collection for clinical trials has not kept pace with the industry’s rapid growth. Innovative software solutions and interoperability breakthroughs are out there, but discover how the clinical research world has been slow to adapt.

Understanding The Scope And Pain Points Of Study Start-Up Part 1: The Site And CRO Perspective

In this series of webinars, experts will highlight the difficulties behind study start-up and provide solutions to those pain points along the way.

The Changing Landscape Of Oncology Drug Development

Guidance for navigating unique formulation and handling requirements, novel trial designs and supply chain implications, and regulatory and clinical strategies to support product approvals.

6 Data Linkage Use Cases To Future-Proof Your Clinical Trial

Learn how connecting clinical trial data and real-world data can give a fuller view of the patient journey and enhance evidence generation.

New Podcast Episode
Industry Insights
2022 Clinical Research Associate Survey Summary

The clinical research industry made big changes to adapt to the operational disruptions of a global pandemic. In this article, learn about CRA experiences using a leading eSource technology platform.

The Ultimate Guide For Selecting A Full-Service DCT Vendor

For anyone looking to run a decentralized trial, learn about the fundamental considerations to take into account and why full-service partners are key components to executing successful and efficient DCT studies.

Understanding The Long-Term Effectiveness Of Varying Doses Of A New Therapy For Major Depression

In this case study, find out how a large biopharmaceutical client conducted a Phase 2, six-week, randomized, placebo-controlled, dose-finding trial to evaluate the efficacy, tolerability, and safety of a new oral medication in patients with major depressive disorder.

How Small And Midsize Biopharmaceutical Companies Can Easily Achieve Digital Innovation For Their Clinical Data

In this article, learn how forward-thinking life sciences companies are defining their vision and looking for like-minded partners to execute information technology.

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