Opinion: The Investigator Site of the Future

The perspectives offered in this opinion piece come from the author, who works in a contract research organization (CRO) with a site alliance; from two investigators and a study manager who conduct clinical research; and from personnel at a CRO-like organization with a new hybrid approach that offers staff and processes to help investigators conduct […]

Beth Harper, ACRP Workforce Innovation Officer

Workforce Innovation: ACRP’s New Workforce Innovation Officer Speaks to the Need for Competencies

Beth Harper, president of Clinical Performance Partners, Inc., a clinical research firm, has worked to enhance patient recruitment and retention and improve sponsor and site relationships for more than 30 years. Last month, the Association of Clinical Research Professionals (ACRP) named Harper its new Workforce Innovation Officer. She will spearhead ACRP’s initiatives to lead innovation […]

Jerry Stein headshot

The Hidden Value of Onsite Monitoring

Electronic data capture (EDC), central monitoring, and risk-based monitoring (RBM) have been disruptive to the entire clinical research enterprise. These new technologies and processes offer the potential to increase efficiency while reducing onsite monitoring and data management costs. Sponsors and contract research organizations (CROs) are crafting standard operating procedures (SOPs) which will allow these changes […]

European Medicines Agency

European Medicines Agency Releases First-in-Human Trial Guidelines

The European Medicines Agency (EMA) just unveiled a guidance for first-in-human clinical trials designed to help stakeholders identify and address risks for trial participants. “Participants in these trials, often healthy volunteers, face an element of risk as the ability of researchers to predict the effects of a new medicine on people is limited before it […]

FDA Logo

FDA Gives Industry Green Light on IRB Waivers for Minimal Risk Studies

A new guidance from the U.S. Food and Drug Administration (FDA) assures sponsors, investigators, and institutional review boards (IRBs) the agency “does not intend” to object to an IRB waiving informed consent requirements for certain minimal risk clinical investigations. To remove this obstacle, however, the IRB must be in the position to demonstrate: