Adaptive Monitoring Approach Nets Independent Validation

Picture1I am writing this post from the beautiful Broadmoor resort in Colorado Springs where I attended a gala  to accept the 2013 CIO Award honoring Health Decisions’ adaptive monitoring technology. COO Alicia Paladin provided many insights that contributed to the success of our adaptive monitoring project and joined me at the gala.

All of us at Health Decisions are delighted that CIO’s editors and panel of independent technology experts recognized the business benefits of our approach to monitoring and managing clinical trials. Thanks to all of those involved in reviewing our technology and especially to CIO’s editor-in-chief Maryfran Johnson for honoring Health Decisions and hosting a vibrant event in a beautiful setting.  I’m not only grateful for the award but for the opportunity to benefit from the remarkable concentration of IT expertise and brain power that CIO brought to the Broadmoor.

I would also like to congratulate the manufacturing groups from Amgen and Pfizer for joining Health Decisions as CIO 100 Honorees. Amgen’s project uses a real-time multivariate statistical model to improve manufacturing – a model that sounds a lot like the one at the heart of the adaptive monitoring approach for which CIO honored Health Decisions. The similarities at the core of these two CIO 100 Award winners confirm something that I’ve been saying for years – clinical development can learn important lessons from methods used to improve quality and efficiency in manufacturing.

The description of the benefits of Amgen’s project sounds exactly like the benefits of Health Decisions’ approach to running clinical trials: “The new automated analytics system saves time and allows the team to focus on the trends instead of gathering and charting data. In one case, a yield issue was rectified in less than a day thanks to the new system; with Amgen’s old setup, it would not have become apparent for weeks.”  Picture2

The Health Decisions approach to running clinical trials allows us to resolve many issues in hours or a day instead of weeks. Trial management simply must move beyond the mentality of managing clinical trials based on periodic reports that are out of date when the project manager gets them.

Pharma has long used statistical process control in manufacturing. The mystery is why the industry has not moved faster to apply similar principles in clinical development.  If pharma companies find it hard to accept advice from an innovative CRO about improving clinical operations, they might want to talk to the manufacturing groups in their own companies.

The winning technology from Pfizer involved cloud services that enhance supply chain management and compliance. Health Decisions was the only CIO 100 winner honored for improving the efficiency of clinical development.

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