EDC and ePRO – 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 looking for ways to attract and retain these critical assets.

Site recruitment is only the first hurdle. Once sites are on board, the focus changes to enrolling and retaining subjects. Subject attrition is arguably one of the highest avoidable costs when conducting a clinical trial. Making it easy for pet parents to participate in a study goes a long way towards achieving a high study completion rate.

So, what can be done? Can Electronic Data Capture (EDC) coupled with Electronic Patient-Reported Outcomes (ePRO) effectively be used as ammunition in this fight to get products to market? Let’s look at the savings experienced using a robust EDC with ePRO.

• Sites report a 50% reduction in the time spent on each casebook. When sites know their time commitment is minimized, participation becomes more attractive.
• Data quality is also improved by at least 50% when data is captured using a tool with built-in error checks. This frees study personnel from chasing down typos and allows them to focus on study outcomes.
• When using ePRO, our clients have reported achieving a dosing compliance rate of 100%. Pet owners receive scheduled reminders and can fill out surveys from their couch – not the clinic. Plus, the need for data transcription is eliminated – increasing data quality.
• EDCs that facilitate reuse can reduce database build time by up to 75%. Imagine the QA cost savings that can be realized by standardizing data collection forms.
• The CVM submission and review process can be streamlined by 50% when the EDC generates submission-friendly database exports and is enhanced even further when the CVM’s remote audit initiative is adopted.

What should sponsors and CROs be looking for when it comes to EDC and ePRO solutions in the Animal Health domain?

Electronic Data Capture

• Ease and speed of navigation
• Forms that look like paper forms
• Automated lab interfaces
• Sophisticated error checking
• Site management capabilities
• Summaries for study personnel
• Database export to small files for submission

Electronic Patient-Reported Outcomes

• Available on user’s mobile device
• Email and device notification reminders
• Scheduled surveys
• Automated integration with EDC
• User friendly data collection (radios, check boxes, scales, etc.)
• Fully attributable audit trail
• Media upload

Are you interested in saving time and money and in increasing site and subject retention? Talk to Prelude Dynamics about our solution set.

Read our Best Practices series.