eNovator's Clinical Trials

eNovator Clinical Trials is designed to simplify and streamline the process of conducting a trial. It can be used by anyone conducting clinical trials: Pharmaceutical companies, Biotechnology companies, Contract Research Organizations, or Universities. The template based approach of eNovator allows you to easily launch new trials, ensuring consistency in your business processes and adherence to the trials protocol. All patient information, trials tasks, and critical milestones are captured, monitored, and reported on, ensuring the trial stays on budget and on schedule. With eNovator Clinical Trials you can:

• Reduce errors throughout the trial
• Improve visibility into your trials
• Provide consistency in how trials are conducted
• Maintain regulatory compliance throughout the trials process

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Clinical Trial Challenges
The average clinical trial consumes anywhere from 30% to 50% of an R&D organizations budget, on average costs $30,000 per day, and lasts 6.6 years. Phase one trials have a 90% failure rate, and success rates for phase two trials are half of what they were in the 1990's. Why?

It's because clinical trials have been run as a scientific endeavor, not as a business process. Trials are typically understaffed and the process of managing a clinical trials is prone to error and inconsistency. Manual, paper based processes lead to lost information, poor collaboration efforts, and a lack of visibility throughout the process. The global nature of business today, and continued outsourcing of trials only adds to the problems. The current environment requires adding a stronger business focus and better management practices to the entire clinical trials process.

How eNovator Clinical Trials Solves These Problems
eNovator Clinical Trials helps you manage the information, data, and processes involved in conducting a clinical trial. Unlike stand-alone data management systems or trials management systems, eNovator captures all the information about your patients, samples, drug deliveries, etc. in a single repository. At the same time eNovator manages the trials schedule and metrics, capturing key performance indicators, critical milestones, and automating task management and data gathering. The end result is a single source for all trials related information, with detailed reports, dashboards, and real-time access to information. With eNovator Clinical Trials, you can make smarter decisions based on accurate, up to date information.

Key Features of eNovator Clinical Trials

• Ease of Use – The web-based interface of eNovator makes it easy for users to get up to speed with little training. No software on the desktop means deployment is quick and easy for your IT staff. Drag and drop allows files and other information to be easily imported from the desktop, laptop, or network file servers.
• Security – Built-in security allows for secure access to all patient information. Only authorized users can view, edit, and update information about a patient or trial.
• Template Based Approach – The template based approach of eNovator ensures consistency in how patient information is managed and new trials are created. New patients are created from a pre-defined template which defines the security, required information, associated laboratories, samples, etc.
• Collaboration – Since eNovator is completely web-based, it's easy for users in any location to securely access your clinical trials information. Internal and external users simply use a web browser to login to eNovator Clinical Trials to view, add, or update trials information. Collaborative workspaces allow all trials information to be viewed contextually in a single location.
• Patient Management – All information related to trials patients is securely stored in eNovator Clinical Trials. This includes the state of a patient during or after a trial (active, inactive), personal information, forms, and samples or drugs related to the patient.
• Sample Management – All samples obtained from a patient during the trial are tracked in eNovator Clinical Trials. Sample types, requested quantities, actual quantity, and sample state are all tracked per patient.
• Trials Management – Each phase of the trial is managed. All key performance indicators, milestones, metrics, and tasks associated with each trial phase are defined. Templates ensure consistency in how new trials are created and managed. Automated task assignment and tracking ensures users are notified of tasks that require their attention.
• Reporting – Managers and Executives have access to all trials data through eNovator's web interface. Dashboard views give real time visibility into the trials process. Standard reports can be created automatically or on demand, providing a constant overview of all key trials metrics. Custom reports can easily be configured on any combination of metrics.
• Integration to ELN – eNovator's modular nature means data created in any module is accessible to the trials. Information captured in the Electronic Laboratory Notebook during the R&D process is easily accessible to trials managers.
• Process Automation – eNovator's workflow engine allows your current manual processes to be modeled electronically, optimized, and automated. Metrics captured during the workflow process allow reports to be created showing duration, task start and end dates, and other performance indicators.
• Search - eNovator contains a powerful search engine that allows the user to search on text or meta-data for any object in the system. Search templates can be created for commonly used searches.
• Integration – Ease of integration to other systems allows data and information to be easily pulled into eNovator from other business or scientific applications. This allows you to have a single, consolidated view of all key trials information.
• Configurable – eNovator Clinical Trials is designed to be configurable to your requirements. Configuration menus, check boxes, and pull-downs allow you easily configure the system to meet your needs. Add new metrics, create new templates, and model new business processes without programming.