Study Conduct

Three Questions: Tom O’Leary, Icon

Monday, April 4, 2016

CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn connected with Tom O’Leary, chief information officer of Icon.

[Read More]

Facing protocol amendments head-on

Friday, April 1, 2016

The unplanned costs and delays associated with protocol amendments have prompted many sponsor companies to identify new approaches to simplify protocol designs and reduce the frequency of protocol amendments over the course of the past few years. Yet a new Tufts Center for the Study of Drug Development (CSDD) analysis found that the majority of protocols still require substantial amendments, which led to significantly longer clinical trial cycle times and higher costs.

[Read More]

Trial volunteer death throws spotlight on disclosure

Friday, April 1, 2016

On Jan. 1, 2016, clinical researchers heard news that they dread: Healthy volunteers in a drug trial experienced serious side effects. One volunteer in the French trial died and five others were hospitalized with neurological symptoms. Questions now remain as to how this happened and how the tragedy will affect clinical trials in Europe and in the United States.

[Read More]

Refocusing on risk mitigation in starting clinical trials

Friday, April 1, 2016

While risk management efforts in drug development have focused mostly on post-marketing drug safety, the clinical trials process has its own mix of potential risks waiting to derail a company’s multimillion dollar development programs. These risks include patient enrollment issues, site staffing shortages, drug supply logistical problems, and regulatory delays. Risk-based challenges are escalating as clinical trials become more global and complex, and as market pressures keep rising for new therapies at an ever-increasing pace.

[Read More]

goBalto launches study startup solution Select

Thursday, March 31, 2016

goBalto, a provider of cloud-based clinical study startup solutions, has released goBalto Select for optimizing site selection. With this release, goBalto becomes the first life science software vendor to offer a complete end-to-end platform for starting clinical trials, from site feasibility assessment and selection through to activation, with comprehensive metrics to track adherence to timelines and budget.

[Read More]

The ongoing CRA shortage: Competency versus experience

Monday, March 28, 2016

Ongoing concerns about a global shortage of clinical research associates (CRAs) were rekindled last week at the Clinical Trial Collaborations conference in Boston, Massachusetts, prompting debate about the reasons for and solutions to the problem—and particularly about a two-year experience requirement described by many as arbitrary.

[Read More]

High risk of ignoring individual patterns of medication adherence

Tuesday, March 15, 2016

Hundreds of millions of dollars are spent ensuring operational quality in clinical trials includ­ing site compliance, accuracy of data entry and enrollment targets. Meanwhile, one of the most vul­nerable aspects of the process—whether or not study participants are taking the investigation com­pound—receives surprisingly scant attention.

[Read More]