On the Job: Tackling Waste in Clinical Research

I tried to tally them all, but there were just too many. I stopped counting at 153 pre-packaged laboratory kits that had expired before we ever had a reason to use them in the latest ongoing trial at our study site. Receiving a shipment of such kits from a central lab is a routine occurrence […]

Raymond Nomizu headshot

The Real Reason Sites Need eSource

Most discussion about electronic source (eSource) documentation in the clinical research enterprise starts from a sponsor standpoint, with eSource being viewed as an extension—almost a mobile version—of electronic data capture (EDC). In this view, sponsors provide sites with eSource systems that the sites use to collect data, which are then transmitted to the EDC system. […]

Joanne Perry headshot

How Much Do I Ask For? Budget Negotiation for Private Practices

Successfully getting through the process of budget negotiation can be a daunting task. The contract research organization (CRO) wants to meet the sponsor’s expectations. The sponsor is trying to keep costs down. The principal investigators (PIs) want to be reimbursed for their time. Essentially, it’s negotiating your site’s salary for the time frame of the […]

Pranali M. Wandile headshot

Medical Device Recalls: A Primer

For the purposes of this article, a “recall” is the process of removing or correcting medical device products deemed to be in violation of U.S. Food and Drug Administration (FDA) regulations. In most cases, manufacturers and distributors voluntarily recall a problematic product out of a sense of responsibility for protecting public health from a defect […]