Brodie Reynolds, Senior Talent Partner, R&D Staffing

Is the Lack of Career Paths Hindering Professional Advancement in Clinical Research?

Sometimes you’ve got to get outside a situation to gain a new perspective. When Brodie Reynolds, senior talent partner, Genentech, takes a look at the clinical trial career environment, he’s not crazy about some of what he sees. Prior to rejoining the clinical trial fold, Reynolds worked with American Express and Facebook, among other companies. Returning […]

Jim Nichols

Are You Ready to Meet FDA’s Strict eCTD Requirements?

The U.S. Food and Drug Administration (FDA) has given industry nearly three years to get ready to handle submission of the electronic common technical document (eCTD), so don’t expect much sympathy from the agency today if you don’t comply, says Jim Nichols, COO at Cunesoft. After a few delays, using an eCTD to file the […]

Unified Regulators Complicate Site Compliance Programs

The Medicines & Healthcare products Regulatory Agency (MHRA) in the U.K. and the U.S. Food and Drug Administration (FDA) are working more closely together in new ways to synchronize—and strengthen—each other’s regulatory inspections, according to an anecdotal data research report on trends in practices of these and similar regulatory authorities around the world from […]

Darlene Panzitta

Certification Underutilized in Fight Against Technology Aversion and High Turnover

Clinical trial practitioners are far behind the learning curve when it comes to technology—and it’s not their fault, says Darlene Panzitta, president and founder of DSP Clinical Research, a contract research organization (CRO) specializing in services for small to mid-size pharmaceutical, biotechnology, and device companies in such therapeutic areas as infertility, women’s health, male hormone […]