Newsletter | June 22, 2022

06.22.22 -- IVDR Compliance: You May Need To Rethink Your Clinical Evidence Strategy

 
Virtual Event
Featured Editorial
Industry Insights
Resting Heart Rate Measurement With Philips Health Band In Adults With Lifestyle-Related Chronic Disease

The Philips Health Band (PHB) is a wrist-worn wearable device that leverages accelerometry and photoplethysmography (PPG) sensors to deliver sleep, cardiology, respiratory, and energy expenditure (EE) endpoints. In this study the resting heart rate (RHR) was evaluated for clinical relevance in adults with (or at risk) for lifestyle-related chronic disease using the Philips Health Band. RHR has been identified as a risk factor and a modifiable treatment outcome.

The Next Phase Of Intelligent Regulatory Business Process Automation Is Here

Are you looking for an easy to use and intelligent regulatory information management solution? Work faster and smarter by streamlining business processes to provide a single source of global registration information: Watch the PhlexRIM 2.1 session with regulatory experts Jim Nichols and Aaron Grant.

AI-Powered Insights
In this e-book, discover the uses of artificial intelligence (AI)-powered technologies for clinical trials.
How Should You Prepare For Foreign FDA Inspections During COVID-19?

As the COVID-19 pandemic continues, it is important to understand the expectations of regulators regarding how to facilitate paper-based facility inspections in lieu of those performed on site.

Top 10 Pharma Company To Reduce Time To Route Safety Cases

The client’s central team needed support for pharmacovigilance (PV) triaging and routing of medical information cases that required quick response times. Find out the solution and result of this challenge in this case study.

How To Build Mutually Beneficial Relationships With Advocacy Groups

In this article, explore how, even though the emphasis on patient-focused trials has increased access for patients, it has led to one-sided transactional relationships between industry and advocacy groups.

Featured Editorial
Industry Insights
Few And Far Between With Leslie Michelson

Listen to patient advocacy innovator Leslie Michelson as she discusses the importance of patient support, guidance, and healthcare accessibility.

Continuous Manufacturing And Late-Phase Strategy: The Time Is Now

Explore recent progress in continuous manufacturing and guidance for answering three key questions related to the implementation of continuous processing for late-phase development of small molecule oral solid dosage forms.

                             

EU’s New Clinical Trial Regulation: What Does It Hold For Sponsors And Sites?

The Clinical Trials Information System (CTIS) is a centralized platform for clinical trial application (CTA) and marketing authorization submissions, as well as supervision of clinical trials across the European Union/European Economic Area (EU/EEA). The regulation, which came into effect on January 31, 2022, aims to simplify and streamline routine clinical processes.

Long-Term Follow-Up For Gene Therapies: Innovative, Patient-Centered Approaches

Find out how long-term follow-up (LTFU) studies for gene therapies present unique challenges, and highlight important considerations for different kinds of sponsors, including biotech and emerging biopharma.

Optimizing Decentralized Clinical Trial Strategy And Technologies

Learn why DCT solutions must be considered while identifying and prioritizing how a strategy or technology grants efficiencies in one area while generating complex issues in another.

Linical Americas Delivers TMFs To Sponsors 75% Faster

Learn how one CRO is executing compliant trials quicker after unifying their clinical operations with Vault eTMF and Vault CTMS.

Clinical Leader Live
Industry Insights
The Quest To Improve Efficiency In Site Contract And Budget Negotiations

It will come as a surprise to no one that site start-up is a challenging part of the clinical trial process. Various pieces of research on this topic have put the length of site start-up time (site selection through activation) in the ballpark of seven to 10 months. In the pharma world, with patent cliffs and competitor products looming, each day is valuable, and every delay is costly. To be sure, delays can occur in any step of the site start-up process. However, research tells us that the most problematic step of site start-up is site contract and budget negotiations — by a mile.

Empowering Oncology Patients: Recruitment And Retention Strategies For Optimizing Study Outcomes

In this blog post, learn about the strategies sponsors should consider during the study planning process to maximize patient engagement and retention.

Global Clinical Supply Solutions For Every Trial

A reliable clinical supply chain strategy is as essential as a company’s discovery program. Seek a partner who can help guide a comprehensive strategy and manage day-to-day activities.

Decentralized Trials: How To Develop A Flexible Supply Chain

Explore the opportunities to optimize your supply chain strategy and facilitate direct-to-site, direct-to-patient, and hybrid services utilizing a global GMP depot network.

Hybrid Bayesian And Frequentist Clinical Trial Designs

Most people know that clinical drug discovery is usually conducted using either Frequentist or Bayesian methods. These two statistical paradigms have enjoyed a degree of competition historically, with some statisticians touting the statistical rigor of Frequentist designs and others the intuitiveness and flexibility of Bayesian clinical trials. Recently, though, a number of hybrid methods have arisen that leverage the benefits of both paradigms for singularly powerful clinical trials. There are benefits of these combined methods.

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