Central Laboratories Applications & Studies

  1. Trial Rescue: Site Selection And Prioritization 12/16/2022

    A large pharmaceutical company was looking to validate its list of 100+ US sites for a chronic auto-immune disease study. Leveraging medical claims data, a site-level analysis was conducted to identify relevant patients meeting the trial’s I/E criteria.

  2. Medicenna Gains Precedent-Setting FDA Approval 12/8/2022

    Learn how Medicenna was able to leverage Synthetic Control Arm (SCA) to bolster Phase 2 findings and gain FDA approval to design a hybrid external control arm for their Phase 3 registrational trial.

  3. Preparing A New Drug Application (NDA) With A CDISC Conversion 9/21/2022

    Regulatory submissions are the most critical milestones in clinical research programs. Learn how quality submissions can accelerate time to market, maximize research investments and bring the benefit of new treatments to patients sooner.

  4. Regulatory Approval For Novel Device Achieved With Comprehensive Clinical Data Management 9/21/2022

    Find out how data capture and management activities, programming, and medical writing for a clinical study report were supported to solve the major diagnostic challenge of distinguishing between bacterial and viral infections.

  5. Automated Data Capture To Train An AI Algorithm With eSource 9/20/2022

    Explore why an AI algorithm needs a steady and significant stream of data to become more accurate and prove its efficacy in a clinical setting.

  6. Predictors Of Severe CRS In Longitudinal CAR T-Cell Clinical Trial Data 9/15/2022

    Find out how laboratory tests were analyzed with repeated measurements to identify differences in trends that persist across a variety of study designs, sponsors, and indications.

  7. Improving Enrollment With Better Data 7/20/2022

    The industry hasn't realized the potential of information collected in clinical trials every day. Explore a solution that's changing how data is used to advance clinical trial recruitment and enrollment.

  8. Method Migration Of Size-Exclusion And Ion- Exchange Methods For Monoclonal Antibody Analysis 7/12/2022

    Discover how combining this system with modern UHPLC columns could make data more accurately interpreted through greater efficiency, selectivity, and enhanced resolution.

  9. Trial Tokenization To Understand The Long Term Effectiveness Of A New COVID-19 Vaccine 6/9/2022

    In this case study, learn why a client needed to connect to real world date sources in order to identify potential sources of data that would enable observation of COVID-19 infection rates .

  10. Top 10 Pharma Company To Reduce Time To Route Safety Cases 5/24/2022

    The client’s central team needed support for pharmacovigilance (PV) triaging and routing of medical information cases that required quick response times. Find out the solution and result of this challenge in this case study.