ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Developing Drugs For Rare Diseases: Generating Clinical Evidence

  For rare diseases, scientific breakthroughs often stall before reaching patients. A new approach to generating clinical evidence could change that trajectory.

• Electronic Trial Master File: The Metrics

  Here, the author defines several key ideas surrounding data, reports, and insights, honing in on one that is uniquely electronic and only possible because of the move to eTMF — Metrics!

• How Protocol Design Decisions Shape Recruitment, Data Quality & Study Startup

  Protocol design directly affects recruitment, data quality, and startup speed. Clear workflows, streamlined criteria, and early alignment reduce delays, amendments, and improve reliable study execution.

• Modern Architecture's Impact On UX In Next-Gen Interactive Response Tech

  Explore how Interactive Response Technologies (IRTs) built around microservices models can provide faster initial builds, more rapid change management, and improved built-in test automation.

• How A Small Biotech Partnered With Us To Navigate Trial Complexity With Confidence And Control

  Early-phase trials often evolve rapidly. See how a flexible RTSM approach helped a biotech sponsor manage major protocol changes without disrupting study execution.

• Benefits Of Delegating Your Oncology Trials Patient Screening Process

  Explore the integration of Electronic Health Records (EHR) into oncology clinical trials, highlighting both challenges and potential advancements.

• RWD/RWE In 2023: Regulatory Policy World Tour

  Learn about what the industry considers RWD/RWE priorities for the year, as well as current efforts being taken within each region around the globe.

• How Can Sponsors Enable Research-Naïve Clinical Trial Sites

  Clinical trial capacity in the U.S. is heavily concentrated, and technology is playing a critical role in enabling a shift to expanding site networks and alleviating the burden on sites and patients.

• eCOA 101: What Is Electronic Clinical Outcome Assessment?

  Electronic Clinical Outcome Assessment (eCOA) has transformed data collection in clinical trials by prioritizing patient engagement and improving data accuracy.

• A Better Approach To eConsent: Flexibility With Enabled Technology

  Electronic consent, or eConsent, digitalizes the trial participant consent process through increasingly simplified, interactive, educational models designed to improve comprehension and boost engagement.