Identification of Medical Products (IDMP) has been harmonizing data globally across the drug development lifecycle since 2003. At its core, IDMP uniquely identifies pharmaceutical products and standardizes product information using five international ISO standards to maintain global compliance. For strategic pharmaceutical companies, IDMP can be leveraged beyond that to act as an information and data tool to drive additional value. We will explore what IDMP is, how it has evolved, and what cons

Our have highlighted the implications of conducting clinical trials in a highly regulated industry and how poorly designed or executed clinical trials may lead to underpowered studies, often resulting in the drug development program failing to achieve regulatory requirements. In oncology trials, which are particularly time- and cost-intensive, robust trial design is even more important. Not only do sponsors have more at stake; patients’ lives often depend on receiving the right therapies as qui

In an earlier installment to this series, we focused on scenarios where it’s critical to capture endpoint data electronically rather than on paper. For example, in studies where the data supports a primary endpoint or assesses suicidal ideation, as well as when the study design requires patients to complete daily assessments or integrate data with another data source. Here we address other scenarios where the use of eCOA for capturing patient data is recommended and how clinical trial sponsors

The past few years have witnessed a considerable interest, surge and technological advancement in Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning (DL). This is primarily due to the birth and rapid embracement of cloud computing and open-source software, allowing unlimited storage of any type of data (structured, unstructured, semi-structured or binary) and providing infinite computational ability to process it at scale at an affordable cost with open source tools, software,