12.02.22 -- How To Make Trials More Successful With Medical Monitors

Sponsors are increasingly choosing independent medical monitors to work on their behalf to provide oversight across multiple study sites or multiple separate clinical trials. This article explains the role of medical monitors and how to effectively integrate them into your clinical study team.

In this webinar, industry experts, along with representatives from the FDA, explore some best practices for remote cardiac monitoring. Watch now to learn how investigators can confidently monitor patient safety and sponsors can have confidence that regulators will accept data that are gathered in a remote format.

It is crucial that statistical analytics of clinical trial data steps into the modern era. Last year, TransCelerate launched the Modernization of Statistical Analysis Framework as a model methodology for demonstrating to health authorities that regulatory submissions generated with any analytical software, including nontraditional analytical tools, provide the necessary reliability.

After Phase 1 and into Phase 2 trials, it's time to identify the quickest scale-up path for supplying efficacy trials and commercial demands while keeping the formulation as simple as possible.

Building an accurate budget for a clinical trial comes with a host of challenges. These include, but are not limited to, intricate protocols, large enrollments, shortened timelines, and global sites. By using a benchmarking tool that uses a global data set experts can develop fair market value (FMV) costs.

Explore how real-world data, and administrative claims data specifically, are being evaluated to support activities in the clinical development space.

Discover how Medicenna leveraged a synthetic control arm (SCA) to bolster Phase 2 findings and gain FDA approval to design a hybrid external control arm for their Phase 3 registrational trial.

Clinical ink offers a best-in-class analytics platform to support the development and evaluation of digital biomarkers in clinical trials.