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 […]

Adam Butler headshot

Good Management Practice: Sites as Partners: A Better Way to Develop Clinical Technologies

The rise in the adoption of new clinical technologies in pharmaceutical research is exponential. Many tools considered novel or untested just a few years ago, such as electronic data capture and interactive response systems, are now considered requirements. However, as the use of these technologies has expanded, stakeholders in clinical trials have struggled to ensure […]

Clare Grace headshot

ICH in Focus: ICH E6(R2)—Impacts on Investigator Responsibilities

The International Council for Harmonization (ICH) E6 Guideline for Good Clinical Practice (GCP) dates back to 1996, when clinical trials were largely managed with paper documents. Since then, the scale and complexity of clinical trials have greatly increased. This has given rise to the need to revise ICH E6 to better reflect advances in technology, […]