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…
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…
Embarking on the dynamic landscape of biometrics in clinical research demands finesse and strategic expertise. Here are some golden rules we swear by for a seamless biometrics journey: ✅ Early Allies: Engaging Biostatisticians and Data Managers In the realm of…
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…
What is Hardcoding? The public domain lacks a clear operating definition of hardcoding. Let’s review several definitions: Hardcoding: Inserting or correcting data directly into a program’s source code, bypassing external sources, when data is missing or needs correction [1]. Hardcoding:…
In the ever-evolving landscape of life sciences, adhering to regulatory guidelines is paramount to ensuring the integrity and security of data. One such critical guideline is 21 CFR Part 11. Embracing the Specific Part 11 Requirements: As part of its…
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…
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…
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…
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…









