ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Where PRO Strategy Goes Wrong

  PRO and COA strategy is now central to trial success. Organizations that capture meaningful patient experience data will gain stronger evidence and a regulatory advantage.

• Early-Stage Biotech's AI Advantage Is A Window That Closes

  FDA AI guidance won’t build your strategy for you. Learn how biotech teams can avoid retrofits and design smarter clinical AI from day one.

• EDC For Mid-Study Changes In Medical Device Clinical Trials

  In this case study, discover how a company was pointed to an electronic data capture (EDC) system that was quick to adapt and easy to scale as the study changed.

• How EDC-Based SAE Reporting Reduces Time To Detection And Response

  Serious adverse events (SAEs) play a pivotal role in patient safety during clinical trials, and the right EDC system helps you efficiently track and manage the entire lifecycle of SAE reporting.

• Key CTMS Capabilities To Improve Financial Management

  In clinical research, utilizing your clinical trial management system (CTMS) to its fullest potential can allow for more streamlined financial management, visit management, compliance, patient recruitment, and more. This blog outlines what you should look for in a CTMS to maximize your organization’s return on investment (ROI).

• eCOA/ePRO: Why Patients Deserve Even More Progress

  The shift from reporting on paper to reporting electronically has been happening for years, however, the transition hasn’t always been elegant. Explore how the pandemic has played a role in accelerating the shift to eCOA/ePRO.

• Unified Platform Supports Rapid Implementation Of Rescue Study

  Explore how these integrated solutions helped an emerging biopharma to implement a plan for study build and migration with minimal disruption to sites.

• Essity Uses eConsent To Optimize Enrollment

  See how a global hygiene and health company was able to deploy virtual methods through a strategic partnership to recruit and retain participants, streamline consent, and analyze patient data.

• A Custom IRT System Facilitates Precision Medicine Studies

  As the industry continues to embrace personalized medicine, the ability to implement and support an atypical supply chain is crucial.

• Are You Aiming For The Bullseye Or Just The Target?

  Learn what this author has to say about focusing on a clinical trial's outcome when developing Risk-Based Quality Management strategies.