The number of clinical trials has grown more than 35 times since the National Institutes of Health first made its clinicaltrials.gov site public in 2000. And the data incorporated in the more than 200,000 trials registered to date has expanded to include not only traditional clinical measures, but also translational and outcomes data. Page views alone top 61,000 a day.1
With that much data how can Clinical Project Managers (CPMs) and Clinical Research Associates (CRAs) improve visibility into their trials or spot problems and address issues earlier in the clinical process? Finally, how can they do these things without the help of computer expertise?
Go for Visual Analytics
It is no longer a clinical best practice to wait six months for data to be locked, cleaned, and analyzed. Traditional reporting methods are too slow, cumbersome, and time consuming. Trial data is needed from ‘First Patient In’ -not at discrete time points, but rather in an ongoing manner. Visual data analytics based on electronic data capture make this possible. Faster, dynamic solutions enable the user to quickly analyze disparate data from multiple sources to create a complete picture of what’s occurring in clinical development – as it happens.
Visual Leads to Virtual
Speed, innovation, and agility are what counts the most. That is why virtual biotechs – small companies with a few executives overseeing the outsourcing of biopharmaceutical R&D – have emerged in the last 10 years in response to tightening capital markets. They rely on the leanest development teams and outsourcing to achieve clinical proof of concept for a drug candidate.
This new drug development model coincides with the emergence of faster, flexible visual analytics and business intelligence tools that assist small, nimble companies in their drug development efforts. They use flexible platforms with real-time access to aggregated data and programs for trial management, monitoring, data analyses, and business operations. The right platform can take a virtual firm and its partners from initial study startup with applications for trial timelines and progression to Phase III project management. The question is, what is that “right” platform?
There is no question that making the change from traditional reporting and query tools to a visual analytics platform means less time preparing data, and far more time acting on the insights from it. Incorporating visual analytics into clinical operations provides timely information and actionable insight to keep trials on track. Everyone involved can make decisions based on live, interactive and actionable scorecards that track everything from planned vs. actual budgets, to study milestones including Investigative Review Board approvals and patient visits.
Choosing the right visual analytics platform can help companies achieve clinical operational excellence. But, analytics platforms are only as effective as the underlying expertise available to platform users. At PerkinElmer, for example, our clinical analytics platform - powered by TIBCO Spotfire® - is backed by our years of experience:
- Building advanced analytics solutions to cover drug development workflow needs
- Breaking rigid data silos to power real-time and predictive analytics
- Offering value-added analytics consulting services to adapt the solutions to specific client needs
Empower Your Research
FDA, EMA and PMDA all recommend risk-based monitoring (RBM) of clinical investigations to enhance patient safety, improve data quality, and drive efficiencies. With PerkinElmer’s TIBCO Spotfire® solutions, your visual analytics will provide more valuable insights for RBM as it accelerates data aggregation through continuous collection and automated consolidation. That leaves you with more time to confidently identify and assess issues early enough to improve study safety and efficiency, technology platforms must enable continuous monitoring with near real-time intuitive visualizations, analytic dashboards, and applications.
If you want to take your analytics to the next level, contact us to arrange a personal demo with one of our clinical informatics specialists today.
U.S National Institutes of Health, ClinicalTrials.gov, Media/Press Resources