We had the opportunity to hear a lot of criticism about the design of the latest Range Rover. The similarities with the old model marketed since 2016 are actually quite strong.

Observations about subjects are normally collected for all subjects in a series of domains. A domain is defined as a collection of logically related observations with a common topic. Almost 80% of observations collected during the study (other than those represented in special purpose domains) can fit among three general…

The CDISC Study Data Tabulation Model (SDTM) is a standard structure for datasets that are to be submitted to regulatory authorities. The first step of implementing SDTM standards is to develop a mapping specification document. All collected data for a clinical trial needs to be mapped into domains. Typically, not…

What is GDPR? The General Data Protection Regulation (GDPR) is the primary law regulating how companies protect EU citizens’ personal data. Companies that fail to achieve GDPR compliance are to be subjected to stiff penalties and fines. GDPR requirements apply to each member state of the European Union. it is aiming to create…

What is a biomarker? A biomarker is intended to function as a surrogate endpoint. A surrogate endpoint is intended to substitute for a clinical endpoint. A clinical endpoint is a characteristic or variable that reflects how a patient feels, functions, or survivability. The word surrogate actually comes from the latin…

Most pharmaceutical companies adhere to the ICH E3 guideline “Structure and Content of Clinical Study Reports” when creating a clinical study report (CSR). For exposure analysis , the ICH guideline recommend that the investigational products should be characterized by: . The number of patients exposed . The duration of exposure …

When designing ADaM analysis datasets, you may have various needs for data categorization. A primary need to categorize data is to group similar values for your analysis. ADaM standard allows you to create variables that categorize the information in your dataset. These grouping variables are to be used during the…

PK contribute to the label once the drug has been approved. PK analysis are mainly used in phase one studies. It can have an impact on the study design and cause a change in it. For example, it can affect the frequency at which the study drug…

Programmers are often called upon to program survival analysis and produce tables and figures (For example: Kaplan Meier Curves). Performing such analysts often time involves using PROC LIFETEST What is survival analysis and the kaplan-meier analysis? Survival Analysis represents a set of statistical methods used to estimate the length of time between two clearly defined events. Survival data…