Thought LeadersAoife Hayes, Kevin O'Regan & Julie ScanlonClinical Trials Assitant, Operations Manager & Quality Assurance ManagerAtlantia Clinical Trials Food clinical trials may not be as familiar to ...
A recent influx of digital technology has unlocked tremendous potential for clinical trials. For an industry that has traditionally relied on patients’ paper intake forms and manual data entry into ...
A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...
Handling sensitive patient data is a critical responsibility for organizations involved in clinical trials. To meet regulatory requirements, many rely on SDTM mapping—a process that converts raw ...
Healthcare providers receive data from many disparate sources: hospitals, doctors’ offices, labs and lab machines, medical devices, pharmacies, and more. Investment in the correct infrastructure to ...
Segmed, Inc., a leader in real world medical imaging data for research and AI development, today announced that it has secured an independent Expert Determination confirming that its structured ...
Despite rapid growth, only 9.2% of DCTs are multiregional and over 80% single-country, indicating challenges in international implementation. 2 With regulatory agencies 4–7 underscoring risk-based ...
Electronic Health Records (EHRs) have transformed the landscape of clinical research by providing vast, longitudinal datasets that reflect real-world clinical practice. Their integration into research ...
The development of new medications is a long, complex, and costly process. Productivity—how efficiently a drug developer creates value from their investment—is key to success, yet it often remains ...