Understanding the New FDA Guidance on Decentralized Clinical Trials
Reading Time: 4 minutesIn 2024, the US Food and Drug Administration (FDA) issued final… Read More

Bridging the Gap – TEFCA, Healthcare Data Interoperability, and Clinical Research Use Cases
Reading Time: 5 minutesAccessing data from multiple electronic health record (EHR) systems results in… Read More

Challenges & Opportunities in Implementing Generative AI
Reading Time: 2 minutesThe potential that generative AI may have on nearly all industries… Read More

The Essential 5 Es for Operationalizing AI in Clinical Data Management
Reading Time: 4 minutesModern clinical trials are accelerating towards increased complexity, with their expanding… Read More

An Introduction to Interoperability in Healthcare
Reading Time: 10 minutesWhat Is Interoperability in Healthcare? Healthcare interoperability is the… Read More

Medidata Presents Research at ASH 2024
Reading Time: 3 minutes Blood cancers make up a large portion of cancer types—these… Read More

The Role of Source Data Verification (SDV) and Source Data Review (SDR) in Driving Clinical Trial Data Quality
In a risk-based monitoring (RBM) update released in January, TransCelerate defined source data verification (SDV) as “the process by which data within the case report form (CRF) or other data collection systems are compared to the original source of information (and vice versa).” Read More

National Breast Cancer Awareness Month: Redefining Hope in HER-2 Low
Reading Time: 3 minutesBreast Cancer Awareness Month has occurred every October for over four… Read More

Diversity in Clinical Trials: FDA Draft Guidance on Diversity Action Plan Requirements
Reading Time: 3 minutesThis blog was authored by Ashni Parekh, Global Compliance… Read More

Clinical Trial Site Selection: How to Improve Your Process
Reading Time: 2 minutesIdentifying high performing sites for a clinical trial is a crucial… Read More
