As clinical development grows more complex, sponsors have an opportunity to rethink not only who they outsource to but also how the work is structured. Clinical trials now span more countries, include more procedures and endpoints, depend on specialized technologies, and involve coordination across...
Typically, when people talk about a full-service contract research organization (CRO) they mean a group that handles every aspect of a clinical study, supplying the personnel, the systems, and the processes. The sponsor is spared all operational involvement with the...
Industry wide, the past two years have seen rapid changes in the approach to clinical data management. To some extent, this is the natural result of working through a pandemic, where remote collaboration and efficiency are at a premium. Yet...
At its core, the success of any clinical trial rests on clean, conclusive data. This creates challenges. Throughout a trial, the data must be properly aggregated, scrubbed, analyzed, acted on—and all those steps must be recorded, to assure regulatory authorities...
For a biotech company, sudden growth can come in many forms. When your company finds it necessary to scale quickly while still maintaining complete oversight over every aspect of your study, partnering with a functional service provider (FSP) may be...
In the normal course of a clinical trial, delays are often accepted as part of the process. For instance, data entered by the site may not auto-encode correctly and therefore require further review by a medical coder, generally within five...