Regulatory Affairs White Papers & Case Studies

1. How CRL Automated Their Assay And Scale Throughput 11/13/2023

   Discover how Artel® technology played a critical role in Clinical Reference Labs' exceptionally fast development and scale-up of a saliva-based SARS-CoV-2 assay to meet the unprecedented testing need.

2. A Comprehensive Solution For Critical Sample Analysis 6/19/2024

   Discover how Germfree Laboratories overcame challenges for the Royal Canadian Mounted Police by designing a mobile lab with advanced biocontainment and state-of-the-art communication systems.

3. Fast Data Insights Improve Productivity, Client Centricity 7/20/2023

   Discover how Medidata's Rave CTMS seamlessly met the comprehensive requirements of Catalyst Clinical Research—an exclusive CRO provider specializing in oncology—during a period of rapid expansion.

4. Transforming Quality Processes And Collaboration 4/16/2024

   Learn how a global CDMO improved efficiency, visibility, and collaboration by standardizing quality procedures and expanding them to external partners.

5. Unified Platform Supports Rapid Implementation Of Rescue Study 1/17/2024

   Explore how these integrated solutions helped an emerging biopharma to implement a plan for study build and migration with minimal disruption to sites.

6. Potential Fraud And Misconduct Investigated At Clinical Research Sites 9/26/2023

   Uncover the truth of a for-cause investigation of potential misconduct and/or fraudulent activity on the part of senior management and investigators at one or more sites within a research organization.

7. Streamline Cell Therapy Manufacturing With Rapid And Reliable Bead Removal 5/31/2023

   Explore a Magnetic Separation System designed to enable closed, fully automated, and rapid cell isolation and bead removal, while decreasing variability in cell therapy manufacturing.

8. Consor Engineers: Simulating Sophisticated Pump Flows In A Closed System 4/8/2024

   To provide reliable water delivery for the industrial and irrigation customers in Ferndale, WA, 100 miles north of Seattle, the Public Utility District No. 1 of Whatcom County (PUD) tasked Consor Engineers, a water and transportation infrastructure consulting firm, with conducting hydraulic modeling simulations to assess its current industrial water system and select new high head service pumps for a proposed new water treatment plant. 

9. Implementation Of An X-Ray Inspection System For Mixed Nut Products 6/3/2024

   Learn about an inspection system that addressed the key concern of an Italian nut supplier of ensuring no foreign contaminants were present in the packaged nuts reaching the customers.

10. Case Study: Using Technology To Reduce Operational Burden In Clinical Research 7/23/2024

    The Beat AML® master trial is transforming treatment for people with acute myeloid leukemia (AML), already improving survival for patients enrolled in a Beat AML study vs. standard chemotherapy. Read this case study to learn how a proven EHR-to-EDC system has enabled the success of this impactful trial.