Leveraging Real-Time Reviews: Quality Clinical Trial Data

23 June, 2014, by ClinCaptureTeam

Clinovo, ClinOps Toolkit, and Patient Profiles recently hosted an exciting event at the Bay Club in Redwood Shores, the heart of the Silicon Valley biotech hub. Clinical trial and eClinical system experts shared their specific experiences, challenges, and insights on obtaining and managing quality clinical trial data. The panel also discussed new tools and technologies to improve clinical data quality.

The event was organized by Nadia Bracken, Clinical Trial Manager and Founder of the ClinOps Toolkit blog and event series. The discussion was moderated by Peter St Wecker, Senior Manager of Clinical Research at Theravance. The experienced panel included Marc Desgrousilliers (CTO at Clinovo), Barbara Elashoff (CEO at Patient Profiles), Nancy Isaac (Vice President CA, RA, QA at NeoTact), and Vaishali Suraj (Director of Statistics at Auxogyn). Here is a recap of the main lessons learned from the event.

More Clinical Data From More Sources

Marc Desgrousilliers, CTO at Clinovo, pointed out that the life science industry is experiencing a significant growth in the amount of data they’re collecting claiming that “Roche is expecting to double the data they collect every other year”. Clinical data is flowing from more and more sources, including EDC, ePRO, EHR, let alone new devices and smart biosensors. Unfortunately, clinical data is often housed in different databases and current systems are not necessarily talking to each other. Vaishali Suraj explained that Auxogyn works with three different databases. She has to spend a lot of time cleaning up data as well as identifying and solving discrepancies. This is a potential threat to data quality, as it makes clinical data more disparate and less accessible.

Streamline and Organize Clinical Data

Clinical trial professionals have higher expectations of eClinical technology. We expect to visualize collected data in real-time, from anywhere, at any time. “We need to access data at our fingertips” states Vaishali Suraj from Auxogyn. “Data storage and infrastructure is a major challenge for us, as we are working with large data and images”. The challenge for eClinical system vendors is to organize the growing flow of data, and deliver it to clinical study teams in a real-time and an interactive format.

Empower Clinical Trial Professionals

“Our clients want to be empowered to build their own studies” states Marc Desgrousilliers from Clinovo. “If you can use PowerPoint, you should be able to use a simple system to build your own CRFs and create edit-checks, without a huge upfront IT investment”. Cloud technology is the answer: It is scalable, so it can grow or shrink with the data and it is seamlessly accessible from anywhere in real-time. Marc announced: “We’re working on an easy-to-use and pay-as-you-go platform to build and manage clinical studies from the ground up without any programming skills”. 

Look for Patterns to Mitigate Risk

Nancy Isaac from NeoTact explains that as far as safety, we need to be able to look at the data in multiple dimensions and look for patterns. More importantly, “clinical trials are very expensive” states Nancy “but there is only one thing more expensive than good data, and it is bad data.”

Patient Profiles offers an innovative statistical approach and an eClinical system that allows users to visualize patient data in real-time, and automatically identify and flag unusual data. Their web portal allows all team members to visualize clinical data, aggregate graphs and tables, and drill-down in to individual patient profiles. Patient Profiles automatically runs algorithms to mine your clinical data and identify data that is unusual. The rules are inferred from the data without needing to hard code the error checks. This solution goes far beyond the simple programming that identifies an out-of-range lab value. The software summarizes the error rates by patient, site, and variable to identify where to target monitoring throughout the course of a trial. This allows clinical trials professionals to react faster to protect patient’s safety, as well as save both time and costs in data monitoring.

Patient Profiles | patientprofiles.com | [email protected]

Clinovo | clinovo.com | [email protected]

ClinOps Toolkit | clinopstoolkit.com | [email protected]

Olivier Roth, Marketing Manager at Clinovo

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