Challenges arise throughout every clinical trial, but studies in certain therapeutic areas and indications — such as systemic lupus erythematosus (SLE) — can be especially difficult to conduct. Leveraging technology benefits both lupus researchers and patients. In this podcast, we review:

• The challenges associated with lupus research
• How these challenges impact sites and patients
• How technology can support lupus research
• What functionalities sponsors should evaluate in a technology solution

Doug Pierce: President & Co-Founder, Clinical Ink

Rinah Yamamoto: Principal Scientist, Clinical Ink

On today’s global stage, patient populations and sites are located around the world and speak many languages. Having ePRO isn’t enough — you’ve got to ensure your translation process is using the most effective and efficient migration process possible to keep costs down and timelines streamlined. In this podcast, we explore:

• The translation process and the importance of methodology selection
• How advanced planning can best incorporate input from all stakeholders
• When to start planning for translation

Elsa Lindstrom: project lead for eCOA-specific technology and processes at TransPerfect Tracey Larrow: director of translation and localization services at Clinical Ink

Our guest this month is Pam Ventola, Ph.D., senior science director at Cogstate. She talked with our Jonathan Andrus, chief business officer, about cognitive batteries and rater assessments to ease site burden. Together, they discussed:

• How rater assessments and cognitive batteries have been handled in the past
• Impact of traditional paper methods on sites as well as on data access and review
• Optimal solutions to reduce site burden

Pam Ventola: Senior Science Director at Cogstate

Jonathan Andrus: Chief Business Officer at Clinical Ink

What is the difference between electronic data capture (EDC) and direct data capture (DDC)? What are the benefits of DDC? How can you use DDC to streamline your data and workflow and increase accuracy?

What you will learn:

• Key differences between EDC and DDC
• How a DDC system integrates with data sources including existing medical records
• How the system you select impacts queries, data review, and data cleaning processes
• A recap of the regulatory guidance on DDC