Featured Editorial
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ICH E6(R3) And Defining What Is Critical To TMF Quality
4/9/2024
By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).
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A Structured Approach To Regulatory Information Management Vendor Selection
3/13/2024
Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.
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3 Tips For Selecting Your eTMF Platform
3/7/2024
Each eTMF platform presents its own set of advantages and drawbacks. Be sure to incorporate these three tips when considering a new eTMF vendor and its services.
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eCOA Solutions: Trends, Benefits, & Buying In 2024
2/22/2024
The eCOA solution market is anticipated to capture $15.1 billion by the year 2036, growing at a CAGR of almost 15.1% during the forecast period. Learn more with this market outlook.
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Digitizing The Clinical Protocol: Small Steps For Seismic Change
1/30/2024
A proliferation of clinical trial platform systems has meant increased friction for data exchange. Discover how TransCelerate is tackling this problem with small steps that yield big results.
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Balancing TMF Management After A Mass Layoff
1/16/2024
Discover nine next steps for you and your TMF team to help address the uncertainty of layoffs and maintain an accurate and up-to-date trial master file.
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Enhancing Clinical Trial Efficiency & Compliance With eQMS
1/10/2024
In recent years, electronic quality management systems (eQMS) have emerged as powerful tools to streamline and enhance the quality control processes in clinical trials. This article explores the key components, benefits, challenges, and future of eQMS in the context of clinical trials.
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ClinOps Digital Transformation: Tips For Getting It Right The First Time
1/5/2024
Despite the digital “revolution” being more than 70 years old, digital transformation continues and mistakes are still being made. But that does not need to be the case.
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WHO’s 6 Principles For An AI Regulatory Framework For Medical Product Development
12/14/2023
In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.
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An Overview Of FDA Efforts To Encourage DHT Use In Drug & Biological Product Development
10/30/2023
The FDA issued its Framework for the Use of Digital Health Technologies in Drug and Biological Product Development earlier this year, representing the agency's road map on the topic. Digital health technologies (DHTs) may include wearable, implantable, or software applications, among other approaches. This article takes a closer look at the framework as well as related FDA efforts this year.