Government

WHITE PAPERS AND CASE STUDIES

• Gene And Cell Therapy: Planning For Manufacturing Success Early

  As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.

• Rescuing A Phase 1 Oncology Trial: Long-Standing Experience Saves Study Momentum

  Study transitions are inherently challenging. Here’s what teams should know to stay informed, keep processes aligned, and successfully transfer data.

• City Of Westminster, Colorado, And The Value Of Trustworthy Data

  This case study explores how the City of Westminster in Colorado has implemented a new mobile app, Trimble Unity Mobile for Cityworks, to streamline workflows and reduce manual data entry for water utility crews.

• The Evolution Of EAM/CMMS In Pharma Manufacturing

  Explore pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.

• Relieving The Strain Of Publishing During Regulatory Registration

  Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

• Clinical Trial Disclosure Compliance: A Moving Target

  To date this year, 115 updates to clinical trial disclosure rules have been tracked across global regulatory agencies. See what types of changes have occurred, where they were, and how they are implemented.

• 7 Tips To Improve OT Cybersecurity For Life Sciences

  Leverage the insights of cybersecurity specialists and industry experts to gain a broader context for more informed decision-making regarding actions and next steps to improve OT cybersecurity.

• Electronic Informed Consent In Clinical Research

  This white paper describes the regulatory positions, adoption, and variability regarding electronic informed consent (eConsent) around the world, including Asia Pacific and the Americas.

• Placing Drug Strategies On A Solid Foundation For Success

  Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.

• GSK And Medable Discuss The Next Phase Of DCTs

  GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.

• Improving Patient Health And Safety: Medical Affairs

  A medical affairs department needed leaders with scientific and project management expertise. With no time for training or risk tolerance, a consultant was hired to align activities with development and launch plans.

• How eSource Reduced Benchmark's Protocol Deviations By Almost 40%

  Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.