Comprehend Systems, a clinical software solutions provider, launched Continuous Quality for ClinOps, a solution that enables clinical operations (ClinOps) to deliver high quality clinical trial submissions at a new speed. This cloud-based solution unifies and analyzes ClinOps data and automates alerts and collaboration across executives, teams and CROs. Clinical trial leaders can now focus on what matters and act faster while improving quality, hitting milestones and speeding the delivery of a portfolio of clinical trials. With this additional visibility into trials, life sciences companies can improve trial quality and speed to deliver trial results and get drugs and devices to market even faster.

Clinical trial leaders at pharmaceutical, medical device and diagnostics companies operate with chronic uncertainty about the quality of their trial data due to the inconsistency of current manual processes and data. This poor data quality slows down results, which is why 10% of clinical trials finish on time and 80% of trials regularly miss milestones.

Outdated processes are used to collect, analyze and understand patient outcomes and produce three main challenges:

• Lack of real-time access to operational and clinical data
• Difficult and slow to investigating risks and outliers
• Complexity of cross-functional collaboration.

Overall, ClinOps teams lack the transparency and processes needed to make critical decisions that deliver quality submissions while adhering to regulatory standards within the scheduled timeframe.

“Today’s method of bringing new drugs and devices to market is broken. Many organizations, big and small, are still using Excel spreadsheets and other manual methods to manage clinical trials, often leading to missed milestones and poor data quality,” said Rick Morrison, CEO and co-founder of Comprehend. “Fortunately, technology is completely transforming this antiquated approach, and Comprehend is at the forefront of this transition. As we push to modernize clinical trials, we bring new speed to quality results.”

Comprehend’s Continuous Quality Solution for ClinOps’ gives life sciences companies a new source of competitiveness and the confidence to deliver high quality clinical trial submissions at a new speed. With a user-centric and purpose-built design, the solution is accessible on any device and is fully compliant and validated (21 CFR Part 11). The solution automates the continuous quality lifecycle, features include:

• Analytics and visualizations inform your decision-making and collaboration processes on site and operational performance, safety, efficacy and compliance

• Filtering enables end users to remove redundant or unwanted data from the info stream to facilitate exploration and cohort analysis

• Click-through enables the user to broaden or narrow their exploration from portfolio views down to granular study data even with unique data models across studies

• Forecasts for key indicators that predict future outcomes based on historic facts
• Cross study benchmarking uses current similar and past trials to inform decisions on current trials

• Monitoring system tracks trends and allows user-driven thresholds to raise events in the system. Early warnings enable ClinOps leaders to take preventative action
• Collaboration provides decentralized users with simultaneous views of analytics and ability to create data-driven tasks and workflows
• Alerts and notifications of events can be in app or email or both

• Audit trails allows full auditability of system state from any point in time, including user activity for compliance and report configuration for decision history