The Comprehend Ecosystem

Having an accurate and complete record of patient information is critical to the success of any clinical trial. Comprehend can help ensure source document verification and data readiness, so everything that needs to be reported is reported.

• Access back-end system tables for more complete visibility.
• Establish metrics to keep track of all the data in your audit trail.
• Get notified about adverse events and changes to data as they happen.

The clinical trial management system handles just about every administrative element from planning to completion. By integrating your CTMS data with your EDC data, Comprehend makes it easy to see how your actual data compares to plan—without any data re-entry required.

• View trending metrics and keep your studies as close to plan as possible.
• Manage monitoring reports in real time for more responsive remediation.
• Gain a greater understanding of events that trigger site visits.

Your regulatory binder contains all the documentation you need to prove that your studies are being managed in the correct sequence. Through integration with data from your EDC and CTMS systems, Comprehend enhances your eTMF system for more efficient management and smoother audits.

• Easily report on your expected document list.
• Automatically search metadata fields to reveal missing data.
• Catch protocol deviations faster for quicker resolution.

IxRS systems add another layer of data about the patients taking part in your clinical trials. By integrating your IxRS and EDC data, Comprehend gives you a better, faster way of reconciling information between the two systems.

• Track any changes to patient information or status.
• Ensure that site-generated data matches data generated by IxRS.
• Quickly produce reconciliation reports for key stakeholders.

Patient perceptions, along with information from caregivers and relatives, can be important data points in any clinical trial. These data points are typically collected using computer-based ePRO systems. Comprehend makes it easy to discover trends and understand how questionnaire responses correspond to the patient data you’re collecting in your EDC system.

• Confirm that study participants are completing questionnaires on schedule and compare questionnaire metrics across sites and regions/countries.
• Compare graphical patient profiles to ePRO questionnaires.
• Detect anomalies: In one instance, suspicious subject data entry dates led to the discovery of fraudulent site practices.

Obtaining lab results from third-party providers traditionally means that critical data lives outside the clinical trial database. With Comprehend, you can integrate your lab and safety data with your EDC data and run valuable analytics for actionable insights.

• Overlay lab values onto dosing schedules to understand changes that may relate to toxicity.
• Provide a deeper view into lab data to improve pharmacovigilance.
• Uncover trends and patterns through continuous visibility.

Just like lab data, data from ECGs, MRIs, and other imaging modalities generally lives outside the clinical trial database. From a standard flat file, Comprehend can ingest this data and integrate it with your EDC data for greater access to actionable insights.

• Overlay ECG values onto dosing schedules to understand changes that may relate to toxicity.
• Provide a deeper view into ECG data to improve pharmacovigilance.
• Uncover trends and patterns through continuous visibility.

Sponsors that work with CROs enjoy greater peace of mind when their CROs are integrated with Comprehend solutions. With full visibility across sponsor- and CRO-owned data sources—everything from CTMS and EDC data to IxR and Labs—sponsors gain meaningful insights by using powerful analytics capabilities designed to minimize risk and maximize performance.

• Automate data collection and management—no more spreadsheets means greater accuracy and efficiency.
• Identify risks in real time, across all study-related data systems, and take corrective actions faster.
• Set yourself up for success through more effective CRO collaboration.

The Wall Street Journal has called Sequoia Capital “one of the highest-caliber venture firms” and noted that it is “one of Silicon Valley’s most influential venture-capital firms.” Sequoia invests between $100,000 and $1 million in seed stage, between $1 million and $10 million in early stage, and between $10 million and $100 million in growth stage.

Over the past two decades, Lightspeed has backed more than 200 companies, many of which have become leaders in their respective industries. The venture firm is currently investing out of Lightspeed IX, a $675M fund focused on early and expansion stage investments in the consumer, enterprise technology, and cleantech markets.

Eminence Capital, LP began in 1999 and currently manages approximately $6.6B on behalf of institutions and individuals. The firm focuses on global equity investing and employs both long/short and long only strategies. Eminence utilizes a fundamental bottom-up, research-driven investment process and invests in businesses with the expectation of being long-term owners.

As a leading American seed accelerator, Y Combinator provides startups with early-stage venture funding to cover initial expenses while getting off the ground. Since its founding in 2005, Y Combinator has funded more than 1,900 companies, with a combined valuation of more than $100B.