Life Sciences

One of the challenges that I face at my job is supporting multiple clients that use different versions of Siebel Clinical (CTMS). Not only are they different versions, but each instance has been uniquely configured and enhanced. With many clients to support, plus internal product development efforts, I needed to find a way to run […]

In my last blog post, I presented some thoughts on showing data changed since last review. Today, we will concentrate on the level of scrutiny and what happens when recording the user actions in the review. Not all data may require the same level of scrutiny during a review. Additional focus may need to be […]

Oracle recently announced the general availability of the latest patchset for Siebel Innovation Pack 2016 (IP2016). Patchset 16.9 can be found on Oracle Support, although it is a little tricky to locate. Use these search terms to find it: For Windows, you would select this file: This takes you to the download window and the […]

In my previous post, we discussed some examples of business rules that might be applied depending on how many people are performing a clinical data review. Today, we’ll discuss approaches for selecting the data that is being reviewed. In any data review that occurs multiple times during the course of a study there are two […]

My colleague, Chris Bangma, published a blog post last week that touches on how IBM Maximo, a comprehensive asset management system for managing physical assets, can comply with the FDA’s 21 CFR Part 11 regulation. In particular, he highlights three key areas of the rule that governs the use of electronic records and electronic signatures […]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems Accel-Account Manager Accel-Copy ASCEND (Siebel CTMS) Generally speaking, […]

In a few of my previous blog posts (4 Ways You Can Improve The Clinical Data Review Process and Using On-demand Data With Dynamic Data Writeback In Spotfire), I discussed using Spotfire as an aid for Clinical Review of data along with supporting writeback capabilities to record the user review actions. In the next several […]

Now that February is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in January – they’re ranked in order of popularity, with number one being the most viewed piece. 4 Ways You Can Improve […]

Whether or not we agree with President Trump’s executive orders and policies, on a daily basis, we are getting incredible insight into how he wants to change a number of industries. On Monday, President Trump spoke on reducing regulation and “doing a number” on specific financial rules. Yesterday, he met with executives from the life […]

In my last post, I discussed performing a clinical data review in Oracle’s Data Management Workbench, which takes value added data into consideration. Today, we’ll take it a step further and add external data into the mix. This scenario extends the data available for review by including data from external partners who may be managing […]

This Thursday, we kick of our 2017 webinar series on connected health. To refresh your memory, connected health is a strategic service that helps life sciences organizations improve and manage relationships with customer groups, such as patients, clinical sites, general public, external partners, and employees. Regardless of your department or role, there’s an opportunity for […]

In my previous post, we discussed a simple scenario for reviewing clinical data cleanliness in Oracle’s Data Management Workbench. Today, we’ll discuss a similar process, although this scenario leverages value added data. Establishing value added data is another way to help the clinician to more quickly review the data and spot outliers and questionable data. […]