• Academic Medical Center System Infrastructure Trends and Related Challenges for Conducting Clinical Trials

    Clinical Research News Contributed Commentary | Though academic medical centers (AMCs) may differ widely, they generally share the same tripartite mission: research, medical education, and patient care. Yet, increasingly, complex clinical research systems and processes present common challenges to all of these prestigious institutions, regardless of their differences, that can weigh heavily on research staff.

    Sep 12, 2019

  • FDA Developing Guidance On Real-World Data Quality Issues, Officials Say

    Endpoints News |  As the FDA grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations.

    Sep 11, 2019

  • Use Case: Distributed Ledger Technology In Clinical Trial Supply Chains

    Clinical Research News Contributed Commentary | Effective management of the large volume of data is essential for both the efficiency and the quality of clinical trials. Far too often, clinical operations leaders rely on manually compiled spreadsheets of data to assemble a complete picture of trial participant-related information. Distributed Ledger Technology can alleviate these challenges.

    Sep 10, 2019

  • Saama Data Analytics Platform Runs On Machine Learning

    Clinical Research News | In the world of clinical development, information is stored in a multitude of places, from clinical trial management systems and electronic data capture systems to third-party labs and Excel spreadsheets. Saama's Life Science Analytics Cloud unifies disparate datasets to address the big and important challenges facing everyone, from study monitors to the CEO.

    Sep 6, 2019

  • WCG, Cenduit, Evidera, And More: News From August 2019

    Clinical Research News | August was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from WCG, Cenduit, Evidera, and more.

    Aug 29, 2019

  • FDA Urges Inclusion Of Men In Breast Cancer Clinical Trials

    Forbes | A new document released by the FDA is urging companies to change current practices and include men in their breast cancer trials.

    Aug 28, 2019

  • Pilots Offer Training Ground For EU Clinical Trials Regulation

    Clinical Research News | Dozens of global pharmaceutical companies and contract research organizations are giving the EU Clinical Trials Regulation a "test run" in advance of its long-anticipated launch, now targeted for mid-2021.

    Aug 26, 2019

  • Is Anonymized Data Secure? Not So Fast, Study Says

    Clinical Research News | In light of GDPR, researchers have gone to great lengths to protect their patients' data, de-identifying whole datasets through anonymization. A recent study suggests the data isn't as protected as you might think.

    Aug 23, 2019

  • CTMS: The Heart Of Knowledge And Unified Trial Governance

    Clinical Research News Contributed Commentary | A Clinical Trial Management System (CTMS) is an often-misunderstood software system, yet it is a system that can maintain and manage planning, performance, and reporting functions, along with participant information, tracking deadlines and milestones—essentially the crown jewel of a clinical trial.

    Aug 21, 2019