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Engaging a CRO? Ask Sites What They Think First
Study sites have a tremendous influence on how, when, and where clinical trials take place. They’re the ones training personnel, allocating staff, enrolling participants, managing paperwork, and so much more. So it makes sense that when sponsors need to make important decisions—like which CRO to choose—sites will most certainly have an opinion.
Are you asking them for it?
Blog Post
Study-Size Adjusted Percentages in Integrated Adverse Event Displays
To those of us who regularly create or review adverse event (AE) incidence tables for randomized controlled trials, it may come as a surprise that your typical AE incidence table can be misleading if data was combined from more than one trial. This is due to “Simpson’s paradox,” which, simply put, is the phenomenon that the mere grouping of data can introduce confounding or bias otherwise not present.
News
Unlocking sleep’s role in PTSD
In a groundbreaking study, Ben Vaughn, Rho’s Chief Strategist, Biostatistics & Protocol Design, explores how sleep disturbances impact posttraumatic stress disorder (PTSD). His research sheds light on a novel treatment, TNX-102 SL, which targets sleep quality and emotional memory processing. Discover the potential breakthrough in PTSD intervention in Psychiatry Research’s article: A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder.
News
Understanding GDPR Compliance in Clinical Trials
Dive into the complexities of GDPR compliance in clinical trials in Contract Pharma’s article, Understanding GDPR Compliance in Clinical Trials, an interview with Laura Gatavs, Head of Legal Department for Rho EU. Explore the nuances of when and where GDPR applies, grasp the basics of compliance – both at company compliance level and when negotiating clinical trial agreements – and uncover essential takeaways and best practices for clinical trial sponsors.
Blog Post
Submitting SAS Programs to FDA
Biometrics teams can generate hundreds, if not thousands, of SAS programs throughout the drug development process. So how do you know which ones to submit to the FDA? And how do you go about submitting the programs?
Blog Post
How to estimate the sample size for your next study from a publication with nothing but p-values and Ns
As statisticians, we’re frequently asked to do power and sample size calculations from very thin data. Often, we’re given nothing but an ancient publication containing a few p-values, an occasional mean, and maybe a standard deviation (if we’re lucky). Back calculating something meaningful in these situations can seem intimidating, but it turns out that most standard sample size software can do the work for us when used unconventionally. We’ve outlined 2 such unconventional uses.
Press Releases
Rho Names HR Expert Pam Myers as Chief People Officer
Rho Names HR Expert Pam Myers as Chief People Officer
Blog Post
Innovative Designs in Early-Stage Studies
Innovation in early-stage studies presents the best opportunity to streamline the drug development process. Such designs may not only reduce costs and accelerate timelines but give us better flexibility to address the questions of interest in an increasingly evolving clinical development landscape.
Blog Post
Transitioning Trials Approved under the Clinical Trials Directive to the Clinical Trials Regulation and CTIS
The new European Union (EU) legislation regulating clinical trials harmonises the processes for assessment and supervision of clinical trials throughout the EU. It enables sponsors to submit 1 online application via a single platform (CTIS) for approval to run a clinical trial in several European countries, making the conduct of such multinational trials more efficient.
Blog Post
Planning for a Successful Centralised Marketing Authorisation Application in the European Union
In the dynamic landscape of pharmaceuticals, obtaining a centralised marketing authorisation in the European Union (EU) is a crucial step for companies looking to bring their medicines to a broad market. The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for centralised marketing authorizations in the EU, offering a streamlined process that enables companies to submit a single marketing authorisation application (MAA) and to market their products across the entire European Economic Area (EEA), which includes the EU countries, Iceland, Norway and Liechtenstein, based on a single authorisation.