What are Decentralized Trials? And Why You Should Care

What are Decentralized Trials? And Why You Should Care   Part One of The Decentralized Trials Series  Over the past two years, there has been a mass migration to the digital sphere. Due to the COVID-19 pandemic, people began going to work, attending appointments, and...

The Prelude ePRO App is now available in the App Store!

The Prelude ePRO App is now available in the App Store!  Electronic Patient Reported Outcomes  The ePRO App is part of the Prelude suite of integrated solutions and allows subjects and pet-parents to enter data into the study database from the comfort of their couch....

EDC and ePRO – A Cost Saving Combination

EDC and ePRO in Animal Health Studies – A Cost Saving Combination Vet clinics are busier than ever, and increasingly reluctant to invest the time required to participate in clinical trials – even when they are paid top dollar to do so Sponsors and CROs alike are...

Quality by Design – It’s not an Accident!

Incorporating Quality By Design in EDC-based Clinical Trials Quality by Design (QbD) defines quality as freedom from errors that matter. In the context of an EDC-based clinical trial, this could mean interruptions in study conduct, issues with data integrity, concerns...

Animal Studies: Group-based vs. Individual Subject Workflows

Planning an animal study’s workflow is an artform. Regulatory aspects such as GLP and GCP should be considered as well as the observation element (e.g., a single animal or a group) and the data collection flow (e.g., a line of cows or a single puppy at a clinic)....

Best Practices – Leveraging the Biostatistician

We continually urge our Sponsor/CRO clients to make better use of their study Biostatistician. These professionals have more to contribute than most realize. Yes, they crunch the numbers and help with the final study submission – but they have more to offer than that....