Over the last few years, our industry has become familiar with CDISC standards. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of ...

One of the most important standards when it comes to clinical trial submission is the Analysis Data Model (ADaM). It outlines how to create analysis datasets and associated metadata. This in turn ...

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 ...

Accelerate your clinical trial by implementing clear data transfer rules from day one. Establish a reliable data flow by defining the structure, content, and security for every transfer. Protect ...

rossfarrugia mentioned this on Jul 3 closes #380 add pharmaverseraw for SDTM examples #391 ...

For most websites, the homepage represents your brand’s first interaction with your audience on your website. As the catch-all landing page where people will be sent by default, your homepage needs to ...

Frequently Asked Question (FAQ) pages (or informational hubs) enable your business to respond, react, and anticipate the needs of your audience more quickly and appropriately than other types of ...

Clinical trials generate tons of data—everything from patient demographics to lab results and adverse events. This data often comes from different sources, making it hard to organize consistently.

Continuous medical and safety monitoring of subject data during a clinical trial is a critical part of evaluating the safety of trial participants and as such is governed by protocol procedures and ...