"The Validation Specialist" Richie Siconolfi explores computerized system compliance in clinical research in this three-part series, beginning with a primer on two things: the predicate rules (regulations), guidance documents, directives, and guidelines; and the scientific method.
- KPIs To Consider When Evaluating Success With New Site Technology
- How To Choose Fit-For-Purpose Tech With The Modified Delphi Method
- Early Planning Trumps eCOA Bells & Whistles
- Why We Need Technology Consolidation In Clinical Trials
- Is Blockchain The Solution To Derisking Unreliable Clinical Trial Data?
- A Quick & Easy Guide To Site-Facing Clinical Trial Technologies
- What Sites Need: Trial Technology Integration, Support, And Evaluation
- Some Truths You Can't Avoid About eCOA
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Improving Patient Outcomes With Wearables In Major Depressive Disorder
Learn how medical-grade wearable devices can help advance treatments in conditions like major depressive disorder and paint a more complete picture of patients with this often debilitating condition.
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eCOA Risk Management In The Digital Age
Regulators across the globe are urging the industry to strengthen their data integrity practices. This article addresses the additional considerations that go hand in hand with the increased reliance on eSource data and the expansion of the electronic systems in clinical trials.
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Addressing The Challenges Of eCOA Licensing
How can you combat the instrument licensing and linguistic validation challenges associated with adopting electronic Clinical Outcome Assessments (eCOA), ensuring quick access to source files?
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Rose Research Center Leans On Medrio To Simplify Workflows And Study Design
After experiencing paper processing issues, discover how a company transitioned to digital data collection by using Electronic Data Capture (EDC) and Electronic Patient Reported Outcomes (ePRO) solutions.
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Protocol Amendments And Electronic Consent: Overcoming The Challenges To Reap The Benefits
Learn about some insights that have been gleaned from experience deploying eConsent on diverse trial types around the world.
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How eCOAs Can Benefit Clinical Trials
Learn how the built-in flexibility and freedom of eCOAs can enhance many aspects of a clinical trial.
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Outsourcing Data Management: Challenges And Benefits
Life sciences companies are grappling with a deluge of data. Yet strategic data management outsourcing offers potential benefits amidst regulatory and interoperability hurdles.
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Taking Advantage Of EMA CTR For eCOA Studies In EU
Discover how sponsors can save time and effort by applying for clinical trial authorization once across the EU using the Clinical Trials Information System (CTIS).
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Leveraging Tech And Clinician Review To Improve Risk Detection
Learn why neuroscience therapy developers should start adopting strategies to improve data quality and assess responses using a combination of technology and expert clinician review.
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The TMF Trifecta: Finding Balance In An Era Of Constant Change
In this article, discover TMF through the operational framework of people, process, and technology and how these factors affect stakeholders.
FREE E-BOOK
ISR Reports recently conducted research to understand the pharma industry’s experiences with clinical technology providers. Based on their findings, they created Industry Perspectives On Clinical Technologies, an e-book that discusses characteristics to consider when selecting an IRT provider, why sponsors use more than one CTMS solution, the future of EDC, and more.
Read The E-book!