Programming - TUNECT

CDISC Implementation: Traceability from SDTM to ADaM

Understanding CDISC Standards in Clinical Research: A Practical Guide

May 21, 2026

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

What is a Functional Service Provider (FSP) in Clinical Research?

March 18, 2026

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…

Happy New Year!

January 15, 2024

As we step into 2024, what better way to kickstart the year than with a curated list of the 15 BEST books in Biostatistics and Statistical Programming, handpicked by our team! 15 BEST books in Biostatistics and Statistical Programming Primer…

individual patient data in clinical data

Unlocking the Power of By-Patient Displays: Tabular Listings, Individual Patient Profiles, and Narratives

November 8, 2023

Clinical trials are a complex tapestry of patient data, and at the heart of this complexity lies the need for a nuanced understanding of each patient’s journey. The presentation of individual patient data is a crucial aspect, ICH E3 sheds…

Accelerating Drug Development: Unleashing the Power of Adaptive Clinical Trial Designs

October 30, 2023

In the ever-evolving landscape of pharmaceuticals, the need for innovative approaches to clinical trials has become paramount. Today, let’s delve into the game-changing realm of adaptive trial designs and how they are catalyzing the acceleration of drug development, especially for…

CDISC has released version 2.0 of the Operational Data Model (ODM)

August 29, 2023

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…

Analysis of Covariance (ANCOVA)

August 29, 2023

Analysis of Covariance (ANCOVA) is a statistical technique used to examine whether population means of a dependent variable are equal across different levels of a categorical independent variable, while statistically controlling for the effects of other continuous variables known as…

Hardcoding Documentation: Best Practices for Transparent and Compliant Clinical Trials

August 29, 2023

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:…

Embracing the Win Ratio: Win Ratio vs. Hazard Ratio in Clinical Trials

August 29, 2023

Welcome to Part 2 of our series on the “Win Ratio” methodology in clinical trials! Today, we explore the key differences between the Win Ratio and Hazard Ratio, examining their definitions, clinical trial design, endpoints, interpretation, application, focus, and type…

The concepts of confidence intervals for model coefficients and predictive intervals for dependent variable

August 1, 2023

Let’s dive into the world of linear regression and explore the concepts of confidence intervals for model coefficients and predictive intervals for dependent variable. Coefficients represent the relationships between predictor variables and the response variable. However, real-world data is often…