ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• The Case For Cognitive Assessments In Phase 1 Clinical Trials

  Regulators prioritize patient-reported outcomes. Cognitive assessments in Phase 1 trials detect early drug-related cognitive effects, ensuring safety and efficacy. Signant’s CDR System® is a proven tool for this.

• Navigating Audit Trail Data Regulations And Accessibility Changes

  Data is the single most important thing in a clinical trial. Leverage the power of clinical trial data with effective utilization and access in a changing regulatory landscape.

• Flexible Integrations To Reduce Risks And Increase Efficiencies

  Learn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.

• Implementing ICH E6 (R3) In A Risk Averse Culture

  Get several pointers on how to facilitate a transition to an agile, multi-faceted, and continuous risk and issue management approach aligned with the Statistical Analysis Plan.

• Do CROs Need To Reinvent Themselves In 2025?

  Facing economic pressures, regulatory changes, and technological advancements, CROs must redefine their value propositions and discuss the need for reinvention in 2025 to accelerate into the future.

• 7 Key Considerations For Designing The Optimal IRT/RTSM

  Sponsors can create IRT/RTSM systems that are not only efficient and reliable but also adaptable to the evolving needs of clinical research by focusing on these seven key considerations.

• Discover Why Electronic Revisions Of ICFs Are Easier

  What does the ICF amendment or revision process look like within a digital platform and is this harder or easier than traditional paper-based approaches?

• The Impact Of RWD And Cloud Tech On Research, Health Outcomes

  Far too often, valuable data sources are siloed, disparate, and unusable. Learn how expansive datasets can empower the industry to advance clinical trials and outcomes research, benefiting all communities.

• With The Emergence Of DCTs, Do We Really Need A CTMS?

  As decentralized trial designs continue to grow in popularity, do sponsors and CROs really need a clinical trial management system? Explore whether CTMS is necessary with the emergence of DCTs.

• 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.