ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Simplifying The Regulatory Submission Process With A Modern CTMS

  Working in collaboration with industry representatives, explore the value that pulling the regulatory submission process into a modern Clinical Trial Management System (CTMS) could have.

• Televisits: Why Integrate Telemedecine Features In eCOA Trials?

  Discover new possibilities where patients can complete several of their clinical study procedures remotely, making their participation in clinical trials easier and less cumbersome than site-based trials.

• The Significance Of Quality Data In Meeting FDA Regulatory Scrutiny

  Data Science expert Rod McGlashing explains how scrutiny from the FDA spurs regulatory compliance, resulting in better data quality and the creation of optimal applications for intellectual property.

• RWD For Early Clinical Development Planning And Strategy

  Delve into this use case where Citeline’s Real-World Data was used to inform clinical development strategy and differentiate target product profiles through patient journey mapping.

• Vaccine Trial Sees >90% eCOA Adherence

  Discover how we addressed vaccine trial challenges and drove remarkable success, achieving over 90% adherence to eCOA, ensuring active engagement from the trial participants, and yielding consistent, reliable trial data.

• Fear Isn't A Strategy: Rethinking AI In Clinical Trials

  As AI restrictions rise, needed oversight is slowing trials. This piece explores how delays hurt patients and how sites and sponsors can modernize without sacrificing regulatory trust.

• Introducing Digitally-Enabled Biosample Consent Storage

  Despite the rise of digital solutions in healthcare, paper consent forms are still common in today’s clinical trials. Unfortunately, these paper forms pose significant challenges in retaining the documentation of informed consent for centrally stored biospecimens.

• Executing Concurrent Decentralized RCTs And RWE At Scale

  See how a team of four managed data for 40 peer-reviewed studies and 200,000 participants.

• CAR T Study For Blockbuster Drug Granted Therapy Designation

  Discover how a pharmaceutical sponsor received support for an EDC and IRT database build and got help with data management and biostatistics.

• Using eConsent Data To Populate Site And Sponsor Data Systems

  A top-10 pharmaceutical company was looking to reduce the amount of administrative burden on their clinical trial sites and themselves. See how we accomplished it, using eConsent.