BREEZE eSource CTMS

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The Power of Human-Centered Automation

eSource CTMS

Electronic source documents – eSource – eliminates paper, standardizes and simplies workflow, and reduces errors and omissions. BREEZE eSource goes way beyond visit templates and scheduling. By synchronizing clinical contexts, regulatory and protocol requirements, with study procedures, BREEZE eSource ensures that users not only capture all protocol required data. BREEZE business rules make certain that the data collected are correct, complete, accurate, and compliant. Our dedicated team of clinical trial experts delivers custom, study-specific eSource documents for review and approval before study start-up and supports you throughout the trial and modifies them as needed.

Cross-Module Action Multiplier

Modules seamlessly integrate and work together. Cross-Module Action Multiplier goes a step further by anticipating and completing automatically the additional tasks required by entries you make. For example, completing visits or procedures automatically posts to invoicing, recalculates scheduling, and identifies related actions for an investigational product. Cross-Module Action Multiplier saves you time and prevents errors and omissions.

Study Task Manager

Task Manager replaces the standard and passive ‘to-do-list’. Task Manager dynamically, intelligently, and automatically generates all action items and tracks them to completion. Meet and complete all protocol requirements accurately and easily.

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11000

Patients

300

Trials

Successful FDA Inspections

Features that Deliver

Integrated Accounting

Accounting integration and coordination with all the other modules captures each and every charge automatically without fail. Budget line items, extra fees, unscheduled items and proceddures , scheduled visits and procedures post immediately for invoicing as soon as soon as they are completed. Manage cash flow projections, receivables, and payments by item and by category for rapid reconciliation and financial planning.

SAE and Deviation Reporting

Intelligent Report Assembler enables you to document and report Serious Adverse Events (SAE’s) and deviations, for example, in less than five minutes. The additional benefit of remote access helps you accomplish complete submissions, including PI evaluation and decision-making, in record time and with less effort.

Regulatory Documents, eConsents, and GCP enforcement

The electronic regulatory documents module organizes and updates all regulatory documents. It is dynamic and maintains strict GCP compliance without conventional binders, filing, and clutter.
Compliance with 21CFR11 and electronic signatures facilitates PI review and subject consenting.

Automated Investigational Product Accountability

Receive, dispense, collect, account, and verify all investigational product for each subject quickly and accurately. Internal checks and automatic tracking proactively control and guide your every step. Monitors can verify and ship returned drug effortlessly, saving valuable time and money.

Direct to EDC without Transcription

eConnect interfaces with the largest and most popular EDC system in the industry, Medidata Rave®. eConnect is configurable to transmit study data directly to the electronic case report form on sponsor approval. Our team of industry experts have developed the infrastructure to interface with any current or future EDC system, providing pace-setting eSource to EDC and automatic and instantaneous source data transmission and verification.