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Implications of Assessing Overall Survival in Oncology Studies
The FDA’s August 2025 draft guidance reshapes oncology clinical trials by requiring pre-specified overall survival (OS) analysis in...
Automated Evidence Generation for Regulatory-Grade Real-World Data
Manual data abstraction can’t keep up with new FDA and EMA RWE standards. This whitepaper explains how automated...
The EMR Interoperability Dream vs. Clinical Research Reality
A Practical Guide to the 21st Century Cures Act, FHIR Data, and Bridging the Gap for Regulatory-Grade Evidence
Discover the real-world challenges of EMR interoperability in clinical research. Learn how the 21st Century Cures Act, FHIR...
ICH GCP E6(R3) Implementation: Practical Approaches and Real-World Considerations
ICH GCP E6(R3) implementation requires strategic planning beyond basic compliance. This practical guide covers realistic 12-18 month timelines,...
eConsent Readiness Guide in 24 Countries
eConsent regulations can vary widely across borders. Download this whitepaper to learn the regulatory stances of 24 countries...
eConsent Readiness Guide in 18 Countries
3 ways to unlock the value of real-world evidence (RWE)
Learn best practices on RWE, Castor's offerings for collecting RWD, and 3 different RWE case studies from Castor...
2023 Guide to Clinical Data Collection under the EU Medical Device Regulation (EU MDR)
Learn key compliance requirements, data collection tips, and important dates for the EU Medical Device Regulation in this...
What Patient Experience Can Learn from the 7 Principles of Universal Design
Learn why having a good user interface is crucial for enrolling and retaining patients in a decentralized clinical...
SCOPE 2022 | Next-generation clinical data management
Join Castor's own Kimberly Tableman as she discusses clinical data management and how moving away from paper CRFs...
The pillars of research in 2035
Join Castor's Derk Arts and Kimberly Tableman as they discuss what they expect clinical research to look like...
DTx Clinical Trials and Data Standardization
In this paper, Castor explores the benefits and challenges of Digital Therapeutics (DTx) trials and provides recommendations on...
Choosing Your Best Route to DTx Commercialization
In this guide, Castor discusses routes to digital therapeutics commercialization and tools to meet the challenges on the...
Navigating the DTx Regulatory Landscape
The regulations around digital therapeutics (DTx) are constantly changing. Learn how DTx providers are trying to overcome these...
Regulating Digital Therapeutic Cybersecurity: Today and Tomorrow
Cybersecurity has become a concern for Digital Therapeutics (DTx) developers and regulatory bodies. Learn to balance functionality &...
Overview of EU Medical Device Regulations
Medical device regulations in the EU have recently undergone a major overhaul. Learn the key tenets of MDR...
eConsent Readiness in 12 Countries
eConsent is imperative for continuing research during the COVID-19 pandemic and beyond, but regulations can vary widely across...
Demystifying CDISC standards in the modern era of Decentralized Clinical Trials
Learn key compliance requirements, data collection tips, and important dates for the EU Medical Device Regulation in this...