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....

Why Sites Prefer VISION™ – Part 3 – Ease of Navigation

We consistently get feedback from our clients that their sites prefer working with VISION™. When sites know they will be using a preferred EDC, they are more likely to participate in a study, are better at meeting enrollment objectives, and are more likely to adhere...

Why Sites Prefer VISION™ – Part 1 – Integrated Audit Trail

We consistently get feedback from our clients that their sites prefer working with VISION™. When sites know they will be using a preferred EDC, they are more likely to participate in a study, are better at meeting enrollment objectives, and are more likely to adhere...

Best Practices for eClinical Mid-Study Updates

There are plenty of reasons it might be necessary to make a change to an Electronic Data Capture system after data collection has begun for a study. These range from simple to complex and may stem from a protocol amendment. Some examples include: Modifications to eCRF...

Best Practices for Managing Site Invoicing in Clinical Studies

Sponsors and CROs invest a lot of time and money in recruiting sites for clinical trial conduct. Sites whose personnel are familiar with EDC and GCP, and who have demonstrated their ability to accurately follow protocol procedures are incredibly valuable resources....