Traditional paper-based processes and multi-vendor eClinical models can create headaches for clinical pharmacology units (CPUs) conducting early phase clinical trials. From monitor travel to paper transcription and beyond, a lot of time, resources, and budget end up contributing little or nothing to the actual process of collecting data and caring for patients. By enabling site staff to capture source data electronically and sync it directly to our EDC with no manual transcription, our Direct Data Capture (DDC) tool can accelerate data entry, maximize data quality, and ensure patient safety – all while keeping costs within the typical budget of a CPU.

How Does it Work?

Medrio DDC, the industry’s leading direct data capture solution, is a nimble tablet application built for site-level source data capture and seamless data exchange with Medrio EDC.

Medrio DDC is:

• Accurate: Ensure higher-quality data by eliminating transcription errors
• Efficient: Streamline data entry and monitoring
• Cost-effective: Reduce clinical trial costs by cutting out SDV, double data entry, and more – all while only paying for modules your studies need
• Safe and Compliant: The FDA and EMA have demonstrated strong support of the technology

Here are just a few of the burdens of traditional paper processes that Medrio DDC eliminates:

• 19 hours per study – Average time required for a site to create source form templates.
• $15k per year – Average per-site cost of creating paper source forms.
• $55.3 million – Industry-wide annual cost of transcribing data from paper to EDC.

And here are some of the challenges associated with using a multi-vendor suite for EDC and direct data capture:

• Duplicate build – Each database must be built once in the EDC, and again in the eSource platform.
• Integration – Organizations have to invest time and budget in APIs to enable the two platforms to exchange data.

DDC Compared to Paper

Research has shown that our Direct Data Capture tool, compared to paper processes or multi-vendor models, can yield:

• 42% increase in site productivity compared to traditional paper processes
• 90% reduction in transcription errors
• 50% reduction in monitoring time
• 50% savings on data management costs

The Bottom Line

All of this enables CPUs to more quickly detect patient safety signals and help sponsors get answers to the scientific questions at the heart of early phase studies. Organizations can avoid common headaches that come from slow paper source form creation, unforeseen events that delay on-site monitoring visits, and more.