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...

Visit us at the 2022 Annual SQA Meeting!

Prelude Dynamics is proud to announce our participation in the 2022 Annual SQA Meeting. You can connect with us at this event in two ways. Attend this informative presentation by Ann-Marie Kiser (Director, Quality Assurance) and Alex Peters (Project Manager). What: ...

Survey Says: Sites Prefer VISION™

We recently surveyed a group of current VISION users and were happy (but not surprised) with the results. Prelude Dynamics continually strives to improve our user’s experience, and it looks like our efforts have paid off. 100% of those surveyed indicated they...

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....