04.14.23 -- Unlocking The Potential Of RWD In Rare Disease Trials

In the first quarter of 2022, more than 50% of sites cited staffing as their top issue. This lack of personnel impacts all aspects of the clinical trial process. As a sponsor, creating a lasting solution calls for working together with your CRO and the site to overcome the hiring challenges. However, there are small measures you can take independently. This article shares four key strategies.

Bellerophon Therapeutics, a clinical-stage biotherapeutics company, saves its clinical development program using objective, continuous digital outcome measures.

Clinical trials are changing due to multiple forces affecting what was once a very standard approach. Gain insight into how this notion of alteration has been constantly streaming the industry.

Harbor Clinical’s team of GxP auditors is available to help you plan, schedule, manage, and conduct your site/vendor audits.

Medidata Remote Source Review is a cloud-based solution that rapidly and remotely enables monitors to acquire critical documents, automate document workflows, and allow for review.

Real-world data (RWD) has proven to be valuable in studying rare diseases. Incorporating RWD has led to the identification of previously undetected cases and the monitoring of treatment outcomes. However, challenges such as the lack of standardized data collection and analysis methods still exist. To replicate successes, researchers should collaborate to establish standardized protocols, thereby advancing our understanding of rare diseases and improve patient outcomes.

Personnel shortages and expertise gaps across the biopharmaceutical R&D paradigm require strategic approaches to mitigate risk by responding to the evolving demographics of the global workforce.

Gain industry insight from a collective of experts on the importance of clinical data as a critical asset.

Consider these key principles when developing and implementing machine learning governance policies.

Discover how the right data visualization tool can help medical monitors to tailor and improve their data review processes and enhance their ability to identify safety signals both quickly and surely.

Acorn AI by Medidata is uniquely positioned at the nexus of historical clinical trial and real-world data. It’s SCA solution can bring value to trials and help increase the probability of success.