ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Shaping The Future Of eCOA User Acceptance Testing

  Proactive planning by sponsors and early User Acceptance Testing (UAT) involvement in the eCOA design process can substantially improve study quality, efficiency, and consistency.

• From Startup To Public Company: Scaling Finance Operations

  When basic tools no longer support your growing company, robust systems, such as ERPs, become essential for managing complex financial reporting, regulatory compliance, and multi-entity tracking.

• eReg Benefits For Clinical Research: Use Cases For All Types Of Sites

  Unearth the different kinds of eRegulatory use cases for diverse clinical site types and other eRegulatory capabilities designed to serve all sites.

• What Are Decentralized Clinical Trials (DCTs)?

  Discover how DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, and direct delivery of study drugs and materials to patients’ homes.

• 12 Items Auditors Look For When Reviewing An Investigator Site File

  Maintaining complete, compliant documentation on top of managing the complex processes and interactions of clinical trial conduct can be challenging. Explore twelve items to help you prepare your ISF for an audit.

• How Efficiencies In Trial Builds Facilitate Quicker Data Collection

  Discover how the integration of EDC technology benefits researchers and can hasten treatment and therapy development, improving the lives of patients.

• AI, Virtual Participants, and the Evolving FDA Regulatory Landscape

  Understanding emerging requirements around transparency, risk, and governance is essential for responsibly advancing AI-driven innovation in regulated environments.

• The TMF Trifecta: Finding Balance In An Era Of Constant Change

  In this article, discover TMF through the operational framework of people, process, and technology and how these factors affect stakeholders.

• 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).

• Focusing On Patient-Reported Outcome Measures And eConsent

  Learn how digital solutions can contribute to a more participant-centered approach and potentially enhance the regulatory utility of PRO data while improving the overall quality and efficiency of oncology trials.