Compliance News, Reports & Events

Compliance news, white papers, reports, and events from PharmaLeaders. New content daily, on our website and delivered right to your inbox.

FDA Issues Development Program Guidances to Assist Drug, Device Sponsors

The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, top drug and device manufacturers have relied on FDAnews’ insightful coverage with two of the industry’s most-trusted publications: Drug Industry Daily and Device Daily Bulletin Premium. These ...

Validcare announces the integration of Real-World Research (RWR) Ltd into the Validcare Digital 1st CRO platform

Denver, CO. – August 2, 2022 Today, Validcare announces the integration of Real-World Research (RWR) Ltd into the Validcare Digital 1st CRO platform. RWR is a global leader in providing Real-World Evidence solutions to the pharmaceutical, biotech and medical device industries. Dr. Stuart McCully, CEO of RWR said “Until now we’ve provided sponsors with the regulatory intelligence needed ...

Using AI in a heavily regulated environment: drug and vaccine inspection

Article authored and contributed to PharmaLeaders by: Tristan Salomon, a Machine Learning, Big Data and AI expert. He’s the founder and CEO of Axom, a company that helps customers integrate machine learning into their processes with a special focus on visual inspection and traceability for the healthcare market. In August the news about Japan suspending 1.63 million ...

Five Ways Study Sites Benefit from Remote Monitoring

Authored and contributed to PharmaLeaders by Jeff Pool, VP of Revenue at Florence Healthcare Failed remote site access and monitoring attempts have left study sites with a computer full of access portals, FTP logins, document vaults, and emails. Why do sponsor remote site access and monitoring rollouts fail? Because the sponsor focuses on solving their access problems ...

Whitepaper: Execute a 5-Step Framework for Data Compliance in Healthcare Marketing in the 2020s

The 2020s will transform how consumers and businesses interact with each other as vast amounts of personal and contextually relevant data will be generated. These changes will demand organizations implement a new framework for deploying and managing communications, for implementing innovative omnichannel marketing strategies and tools, and for acquiring and utilizing data. This whitepaper explains how to ...

Healthcare Marketing Trends for 2019 Emphasize Better Targeting with Cost-Effective Advantages

As healthcare marketers strive to keep pace with data technologies for better targeting and conversion, budgeting for 2019 becomes a formidable challenge. Questions about competitive advantages and cost-effectiveness drive conversations. Yet, the focus of forward-thinkers is shifting to better data for targeting faster and sooner in the engagement lifecycle. “We are seeing a dramatic increase in ...