• ‘Professional Patient’ Detection Now A Clinical Study Essential

    Clinical Research News | After more than a decade in the business of detecting “professional patients,” Verified Clinical Trials is a familiar name to stakeholders across the research enterprise—including the nefarious players who ride-share from city to city in search of unprotected sites where they can enroll in studies purely for the financial gain. It’s an underappreciated underground economy that is costing sponsor companies time and money and, in some cases, completely shutting down studies, according to Mitchell Efros, M.D. FACS, CEO of Verified Clinical Trials.

    Apr 13, 2022

  • Seqster Launches Real World Data Tools on Salesforce AppExchange

    Clinical Research News | Seqster PDM has launched SeqsterOS, the operating system for patient registries and clinical studies on Salesforce AppExchange integrated directly with Salesforce Health Cloud. SeqsterOS seeks to empower life science enterprises to seamlessly integrate patient-consented Real World Data, including electronic health records (EHR), genomics, and device data, with a patient engagement layer for their clinical studies.

    Apr 12, 2022

  • EMA Endorses Biomarkers For Type 1 Diabetes Prevention Trials

    Clinical Research News | Following many years of collaborative patient-level data sharing across stakeholder groups, the European Medicines Agency (EMA) recently endorsed pancreatic islet autoantibodies as enrichment biomarkers for type 1 diabetes (T1D) trials focused on delaying or preventing the disease. The Qualification Opinion appears on both the EMA website and that of the Critical Path Institute’s (C-Path) Type 1 Diabetes Consortium (T1DC).

    Apr 8, 2022

  • Building Clinical Trial Infrastructure for Greater Diversity

    Clinical Research News | The life sciences industry has faced recent criticism for its continued challenge to boost diversity in clinical trials. Reports suggest that the US Food and Drug Administration (FDA) is currently at work on guidance that will define how the agency would interpret “adequate representation” of ethnic, racial and age diversity to increase representation of traditionally underrepresented populations in drug development. This will ensure organizations are broadening eligibility criteria through inclusive trial practices and trial design.

    Apr 8, 2022

  • Matching Japan’s Real-World Databases To Research Purposes

    Clinical Research News | Japan has a variety of databases available to researchers, but knowledge and experience is needed to understand the characteristics of each one and select wisely, according to two representatives of CMIC Group, the country’s largest contract research organization. The database options are tied to Japan’s publicly funded healthcare system that provides universal health insurance and the freedom to choose among medical institutions offering consistently high-quality, low-cost medical care.

    Apr 7, 2022