Central Laboratories Featured Articles
-
Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials
5/10/2023
The benefits of real-world data (RWD) have been so promising, the FDA now recognizes RWD — and corresponding real-world evidence (RWE) — as valid tools for monitoring the safety of products post-market and, in some cases, for making regulatory approval decisions. At Freenome, we first integrated the use of RWD during a clinical study launched in 2022 for the early detection of multiple cancers. Along the way, we’ve discovered several benefits RWD can bring to any clinical research program.
-
Why Developing A Metrics-Driven Culture Is A Clinical Operations Must-Do
4/14/2023
The number of systems used to support the conduct of clinical trials has increased and the amount of data used to monitor our portfolio, studies, and processes has soared. While there is still value in using traditional dashboards and reports, the use of advanced analytics and RWD/E is enabling us to ask more sophisticated questions to be more predictive — what will happen — and prescriptive — how to make it happen.
-
AI And Healthcare Disparities: Driving A Wedge Or Closing The Gap?
3/31/2023
The enthusiasm for the role of AI in upgrading global health and care provision is justified, provided we understand that the path to success is just as much about communication and collaborative development as it is about the raw potential of the technology itself. Because realizing this technological potential requires us to consider the role of people and processes in an integrated approach.
-
The CDISC Open Rules Engine (CORE): Open-Source Software For Clinical Trials
3/29/2023
Open-source software development, widely used across most industries globally, has recently been gaining ground in clinical research. Discover how CDISC's Open Rule Engine (CORE) can make sharing standardized data sets easier and improve your workflow.
-
Unlocking The Potential Of RWD: Validating Prevalence Estimates For Rare Diseases
3/27/2023
Real-world data (RWD) has proven to be valuable in studying rare diseases. Incorporating RWD has led to the identification of previously undetected cases and the monitoring of treatment outcomes. However, challenges such as the lack of standardized data collection and analysis methods still exist. To replicate successes, researchers should collaborate to establish standardized protocols, thereby advancing our understanding of rare diseases and improve patient outcomes.
-
Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny
3/27/2023
We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.
-
What Core Outcome Sets Can Do — If We All Adopt Them
3/22/2023
A single trial provides just a snapshot of evidence. Many trials provide a summative account of how effective an intervention can be. But when the selected outcomes are different from trial to trial, it becomes much more challenging to reach a conclusion. Stuart Nicholls of the Ottawa Hospital Research Institute advocates core outcome sets as the remedy.
-
TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability
3/20/2023
There is a growing desire within the clinical trials industry for better data integration — not just to help regulators, but also to help sponsors manage trials more effectively. The recent affiliation of the TMF Reference Model with the Clinical Data Interchange Standards Consortium (CDISC) may become key to making this possible.
-
Dispelling 4 Common Myths Of Data Quality Governance
3/9/2023
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
-
Are Baseline Measurements Reliable? How RWD Can Help
3/6/2023
Baseline measurements presume to establish physiological and/or metabolic status before introduction of test drug(s). But what if they aren't truly reflective for a particular patient? Introducing real-world data (RWD) might be the answer for improved accuracy.