By definition, rare diseases are those that affect fewer than 200,000 pa­tients. But taken collectively, they are anything but rare. Over 25 million Americans suffer from one of 7,000 rare diseases.

To be effective, rare disease trials must avoid issues with enrollment or data quality that threaten statistically meaningful results. Out of every 30 patients pre-screened for the average trial, only seven complete it. Reten­tion and compliance efforts are a high priority issue for clinical operations teams.

At the same time, maintaining a high level of data quality is a chal­lenge for any study with increasingly complex protocols and increasing data volume in siloed data sources. From missing endpoint data to open queries, there are many opportu­nities to lose track of data qual­ity and negatively impact milestone achievement.

How have best practice rare disease study teams overcome withdrawal and data quality process challenges? By transforming the processes from reactive, after-the-fact and manual to proactive, real-time and automated, with purpose-built Clinical Intelli­gence application software.

Clinical Intelligence software en­ables ClinOps, Data Managers and Medical Monitors to continuously improve speed, safety and efficiency of a portfolio of clinical trials—across teams, sites and CROs. With power­ful data aggregation, real-time moni­toring, statistical analysis and team collaboration capabilities, Clinical Intelligence:

• optimizes the portfolio oversight, enrollment, subject compliance and site productivity processes that enable ClinOps teams to deliver milestones on time.
• enables ClinOps to proactively manage studies to risk thresholds and optimize site resource alloca­tion to keep studies on time and within budget.
• provides continuous insights into medical outliers and trends, giving Medical Monitors the efficacy and safety investiga­tion speed they need to lower risk and deliver quality results.
• enables Data Management teams to quickly and scalably create organization specific KPIs, KRIs and analytics.

Written by Guest Writer Rani Hublou. Hablou is the Chief Product Officer at Comprehend. Rani focuses her team on enabling prospects and customers on Comprehend clinical operations solutions. She manages go to market strategy, lead generation, sales enablement, product marketing and branding. Her enterprise marketing experience is derived from her years with B2B software companies: BEA Systems, SAP, VMware, PSS Systems/ IBM, OneLogin, BroadVision, Icarian; McKinsey & Co and Accenture; and nonprofits. Rani holds a Bachelor and Masters in Engineering from Stanford University.

This article was reprinted from Volume 23, Issue 08, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>