CDISC Implementation: Traceability from SDTM to ADaM
Clinical research generates a large amount of data: protocol-defined assessments, CRF data, laboratory results, adverse events, exposure records, endpoint data, statistical analysis datasets, tables, listings, figures, metadata, and regulatory submission packages. Without standards, every sponsor, CRO, vendor, and system may…
FSP (Functional Service Provider) refers to an outsourcing model
How does a CRO interact with a sponsor? What is project-based delivery, what is FSP, and what hybrid models sit between them? What do the evidence – and real delivery practice – suggest for biometrics teams? In clinical development, outsourcing…
CDISC version 2.0
Still remember the XPT file limitations? Variable names confined to 8 characters, labels capped at 40, and data restricted to 200? If you’re curious about merging metadata with data, like utilizing Define-XML / Define-JSON, we’ve got some exhilarating news for…
Data Management Masterclass
Looking to start or advance your career in data management? Here’s a curated list of top courses (Udemy, Coursera and EdX) to enhance your skills and expertise, which TUNECT CRO highly recommend: Data Management Masterclass – The Complete Course [https://lnkd.in/gMaJqx_s] Data Management and Visualization (SAS or Python…
Senior Data Manager skills
Are you a fan of world-wide cuisine? TUNECT CRO is here to present you with a recipe for the best “Senior Data Manager-style Makizushi”! Just like the perfect combination of ingredients creates a delicious sushi roll, the following skills and…
Handling Missing Data Cheat Sheet
Missing data can be a common challenge in research studies, but fear not! Understanding the nature of missing data is essential for accurate analysis and robust conclusions. Introducing the “Handling Missing Data Cheat Sheet” by TUNECT CRO, a valuable resource…
electronic Clinical Outcome Assessment (eCOA)
Uniform terminology, serving as the fundamental language, holds paramount importance across various domains of human activities, and this truth extends to the rapidly evolving domain of electronic Clinical Outcome Assessment (eCOA). As a young direction, standardizing eCOA terminology is more…
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