Posts Tagged ‘clinical data management’

Migrating clinical studies from one database to another (such as Oracle Clinical to Oracle Clinical or Oracle Clinical to Oracle InForm or Medidata Rave), is a complex process that requires a thorough understanding of clinical data management, technology, and the regulations that govern clinical trials. Join me and my colleague, Richard Gavan, for an informational webinar […]

Next week, we are exhibiting at Oracle Industry Connect (OIC) 2017 in Orlando, Florida. For those not familiar with OIC, it is a conference dedicated to a variety of verticals, including Life Sciences and Healthcare. Prior to the existence of OIC, the Annual Oracle Health Sciences User Group (OHSUG) Meeting was an event devoted to users […]

In the previous post, I talked about varying levels of scrutiny for data review and what happens when recording the user actions. In this post, I will talk about the importance of the user interface for a review. Successfully navigating requirements, design, development, testing, user acceptance and ongoing support of any application requires user involvement […]

As was mentioned in a previous post, providing an easy-to-use interface is important for data review, including filtering, audit data, and User Review Action buttons. The user actions buttons initiate recording that all, or a portion, of a review has been performed. In the previous section, we mentioned a Review Timestamp, which is one of […]

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 […]

When it comes to clinical trials, the consequences of bad data can be severe. Research and development becomes complicated and lives can be put at risk. The need for clean clinical data is critical for comprehensive reporting and analysis, ultimately enabling safer drugs and devices to be brought to market faster. Join us this Thursday […]

Then we’ve got a special webinar, just for you. On July 21, we will be having a fireside chat with our client, Alliance Foundation Trials (AFT), a research organization that develops and conducts cancer clinical trials. The chat will include a few presentation slides, so that you’re not looking at a blank screen, but much […]

  It’s that time of year again. The event for industry thought leaders and decision makers is just around the corner, and we’re hoping you’ll attend. Even if you can’t attend, we’re still giving you the opportunity to enter to win a SONOS wireless speaker…just because we like you. 

  Let’s face it: Keeping clinical trials on schedule is not easy to do. Whether a sponsor runs into issues with quality, timeline, personnel, or myriad other things with an outsourced partner, it’s crucial to address the problems as soon as they’re identified. There are a few routes a sponsor can take when a study […]

  Last November, I wrote about the new release of Oracle Clinical, Remote Data Capture (RDC), and Thesaurus Management System (TMS), version 5.1. As many companies continue to run these “tried-and-true” clinical data management and EDC systems, the enhancements were quite welcome. Since then, our data management team has been developing a complete Validation Suite […]

  Sponsors are known to work with multiple contract research organizations (CROs). And, depending on the agreement in place with each CRO, data can be captured in either the sponsor’s systems (CDMS and/or EDC) or the CRO’s. If the data is stored in CRO databases, there may come a time when it needs to be […]

  In our last “cloud fact or fiction” post, we identified several reasons why hosting clinical and pharmacovigilance systems is just as safe as housing them on-premises. In fact, in many cases it could prove to be safer. This week we’ll briefly discuss migrating data to the cloud.