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 full-service model, simply receiving key information at specified intervals. This model works very well for...
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 the seeds of change were planted far earlier, with artificial intelligence, data visualization, and other...
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 of their accuracy. As the industry continues to evolve, new solutions to these challenges have...
The modern pandemic has ushered the Biotech, Pharmaceutical, and Medical Device industry into an era where clinical trials require accelerated timelines on unprecedented levels. As such, modern clinical data management teams are responding to the need for intelligent analytical data review by leveraging technological advancements and advanced centralized data management experts. This powerful combination yields...
December 8th – 9th , 2021 London, UK Booth 13 Visit Premier Research at Booth 13 at Outsourcing in Clinical Trials (OCT) UK & Ireland to discuss the common challenges and trends impacting the region such as COVID, steps for defining contractual relationships and getting the maximum from external providers, incentivizing good relationships with CROs...
December 7th – 8th , 2021 La Jolla, CA Booth 36 Visit Premier Research at Booth 36 at Outsourcing in Clinical Trials (OCT) Southern California to discuss the common challenges and trends impacting the region such as COVID, steps for defining contractual relationships and getting the maximum from external providers, incentivizing good relationships with CROs...
November 9th – 10th, 2021 Boston, MA Booth 69 Visit Premier Research at Booth 69 at Outsourcing in Clinical Trials (OCT) New England to discuss the common challenges and trends impacting the region such as COVID, steps for defining contractual relationships and getting the maximum from external providers, incentivizing good relationships with CROs and constructing...
Is Technology Replacing MEDDRA and WHODRUG Coding Specialists in Clinical Trials? All data generated in a clinical trial must be uniformly interpreted to ensure accurate results. Correct medical coding plays a critical role — and how that coding happens may be shifting. How is technology affecting the process of medical coding in clinical trials? Watch...
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 an excellent solution. Complete control over your projects and data Under an FSP model, you...
A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In this blog, we discuss common reasons for clinical holds and provide useful tips for both avoiding and addressing them. Brief background...