Shauna Itri, MA, JD, Shareholder at Berger & Montague PC

Potential Whistleblowers Face Daunting Choice

With images of Edward Snowden or Karen Silkwood in their minds, it’s scary for most people to consider being a whistleblower in the workplace. However, while fraud in the clinical trial industry is extremely rare, as in any other profession, it has its occasional bad actors who subvert regulations either through carelessness or malice. That’s […]

Clinical Trial Managers Grapple with Complex Expectations

Firefighters and other first responders are a critical component of a town’s safety infrastructure. When life and property are threatened, it is these brave professionals who meet the current crisis head on. At the other end of the spectrum, visionaries and builders are also a key foundation of a town. Developers of new structures provide […]

Vatche Bartekian, President, Vantage BioTrials Inc. in Canada

Effective Project Management Controls Costs, Fuels Trial Success

“I strongly believe that having a sound process within your organization, and strong discipline within yourself as a project manager, can help bring down the cost run-offs and complete your [clinical trial] project on time and on budget,” says Vatche Bartekian, president of Vantage BioTrials Inc. in Canada. “If we consider that, on average, it […]

Key Performance Indicators

Focused KPI Program Can Bolster Clinical Trial Quality Risk Management

Crafting an effective key performance indicator (KPI) regime from scratch is no easy task. If your parameters are too expansive, the data can become overwhelming. If too narrowly defined, the program’s full positive impact on your clinical quality risk management system can be blunted. “When we first started, everybody wanted everything to be measured,” says […]

Rising Costs

Skyrocketing Clinical Trial Costs Ding Sponsor ROI

The sometimes-fragile relationship between sponsors and contract research organizations (CROs) probably won’t be helped by alarming new data suggesting clinical trial costs have nearly doubled since 2010, according to Deloitte’s 8th annual report, “A New Future for R&D?” Worse still, trial costs have grown in six of the past eight years. In the report, Deloitte […]