Jan S. Peterson, MS, CCRA, RAC, MICR, ASQ CBA, senior regulatory affairs advisor for the EMMES Corporation

HHS Final Rule Pushes Clinical Trial Sponsors to Publish Research Results

A final rule issued in September by the U.S. Department of Health and Human Services (HHS) gives new “enforcement teeth” to the government’s effort to ensure that more clinical trials publish their results, says Jan S. Peterson, MS, CCRA, RAC, MICR, ASQ CBA, senior regulatory affairs advisor for the EMMES Corporation and incoming vice chair […]

Glenda Guest, CCRA, RQAP-GCP, TIACR, vice president of Norwich Clinical Research Associates Ltd.

ICH Issues Game-Changing Addendum to GCP Guidance

Clinical trial practitioners better prepare for some “big changes” as they begin to review the new International Conference on Harmonization (ICH) E6 Guideline for Good Clinical Practice (GCP), says Glenda Guest, CCRA, RQAP-GCP, TIACR, vice president of Norwich Clinical Research Associates Ltd. and outgoing chair of ACRP’s Regulatory Affairs Committee (RAC). While Guest’s fellow RAC […]

Joshua Jutton, associate director of talent acquisition at INC Research

Survey Paints Rosy CRA Job Landscape

Clinical research associates (CRAs)—or wannabes—who possess strong communications skills, a college degree, and a willingness to live in the New York, San Francisco, or Boston area are at the very top of a talent pool already in high demand, according to an industry analysis conducted by Arris Partners of life sciences job listings posted by […]

David Vulcano

Opinion: What Do the U.S. Election Results Mean to the Clinical Trials Industry?

Undoubtedly, the actions and inactions of the U.S. Congress have direct and indirect effects on the clinical trials industry. Also undoubtedly, anxiety is heightened at times after elections, especially when they result in changes of the administration. Times like these result in the struggle between those on their way out having last-minute opportunities to complete or build […]

Digital Technology

Survey: Digital Tech Use Up in Clinical Trials, But Concerns Remain

Nearly 98% of clinical research professionals plan to use digital technologies to collect patient data within the next five years, according to a study of 166 biopharma and life sciences industry researchers, executives, and technology/software professionals conducted by Validic. Broadly speaking, the study’s findings highlight how digital technologies will become significantly more important in the […]