Newsletter | December 2, 2022

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


Welcome to the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial MonitoringUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
Trial Monitoring
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.

Best Practices For Remote Cardiac Safety Monitoring

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.

Webinar: The Future Of Clinical Data Management Part 3 — The Evolution Of Data Capture And Its Impact On Clinical Data Management

Join Part 3 of our webinar series to learn how the evolution of data collection innovation is impacting clinical data management. You'll discover new skills, techniques, and technologies that are required to review, clean, lock, and transform data for analysis and submission. Click here to learn more.

Clinical Data Management & Analytics
The Case For Implementing TransCelerate’s Modernization Of Statistical Analysis Framework

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.

Setting A Strong Foundation For Late-Stage Development

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.

GrantPlan: Making Fair Market Value A Reality

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.

Is Real-World Data The Real Deal?

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

Medicenna Gains Precedent-Setting FDA Approval

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.

Robust, Scalable Analytics To Develop Digital Biomarkers

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