Life Sciences

While big data is a catchy buzzword and many race to offer their own definition of it, many still struggle to understand what it really means and question its real value. According to a recent survey conducted by Talend, only 10% of respondents were engaged in a large scale big data implementation project, while 36% […]

Ask any IT project manager what one of their greatest challenges is when it comes to putting together a project plan, and they will likely tell you: estimates. According to a study published by Harvard Business Review, one in six projects presents a cost overrun of 200% and a schedule overrun of 70%, with the […]

I recently attended a webinar titled “10 Killer Applications for Digital Signatures in the Life Sciences Enterprise,” in which Rodd Schlerf from ARX, the maker of CoSign, discussed how various departments in a life sciences organization can make use of digital signatures. Although the list I gathered below from the webinar is just a glimpse of […]

Many pharma, biotech and medical device companies are moving towards an outsourced clinical trial management model. This approach eliminates the need for them to run their own trials and, instead, allows them to rely on clinical research organizations (CROs) to conduct them. In last week’s webinar, “Automatically Retrieving and Loading Data into Siebel CTMS from […]

A clinical trial management system (CTMS) is a software application that centralizes the management of clinical trials. It enables informed decision-making based on real-time data and simplifies historical reporting. A solution, such as Siebel CTMS, helps streamline business processes, trim costs, and reduce the time it takes for trials to complete. Deciding whether or not […]

With the recent localized outbreak of Ebola in West Africa, much information and disinformation has made its way to the Internet and mainstreamed media outlets. Given the foggy haze of reality, I thought it would be helpful to publish a summary of important facts – as the science currently supports – about Ebola: how it […]

Oracle’s Argus Safety is a comprehensive safety and pharmacovigilance platform designed to enable pharmaceutical, biotechnology, and medical device companies, in addition to contract research organizations (CROs) and academic institutions (AROs) to focus on product safety and regulatory compliance. With the multi-tenancy feature in Argus Safety, CROs and AROs can provide services to multiple sponsors, while […]

My recent trip to a new client in Hull, United Kingdom, reminded me of a Harvard Business Review management tip that is hard to argue. It conveyed three ways to start your client relationship right to ensure success: Make an accurate first impression. Make them feel comfortable, but also set clear expectations about what you can […]

Imagine accidently deleting lots of production clinical data. What do you do? How do you recover? Those are the tough questions our client was recently faced with when one of their Oracle Clinical (OC) power users ran the Delete Study Information function in the system with the intention of deleting patient data for only a handful […]

The amount of time and money it takes for a drug or medical device to be developed and pushed to market is staggering and continues to grow. However, more often than not, once a product gets approved, the maker enjoys watching it flourish in the global marketplace for many years. Unfortunately, there are situations when […]

In recent years, we have seen many changes to the global “face” of product safety (FDA, 2009). Arguably, these changes modify the traditional focus of product safety from a case management and alert reporting strategy to include a more preventative, pharmacovigilance strategic focus. In order to successfully adopt these changes, it is critical that we […]

Senior Management is always looking for answers about what works, what doesn’t, and how best to design and manage clinical trials. In order to get those answers, all of your trial data needs to be in one place and in a consistent format – this is the only way to extract accurate information. But, how […]