Scientifically Sound Electronic Data Capture
and More

High quality data, efficient processes, consistency and a high degree of customization plus the ability to start any type of research project or clinical study in record time; that's what our clients have come to expect and get from EMMES AdvantageEDC^SM. We can tailor the application to meet your study specific needs whether you have international requirements for language and metric conversion, online and offline data entry, or downloading data from other sources. The system includes a regulatory compliant audit trail, and conforms to 21 CFR Part 11.
Best of all, the application and data reside in the EMMES data center so there's no installation on your part, just internet access. Throughout your project's life we can provide you the raw data in the format of your choice.

Application Service Provider (ASP). With EMMES application services provider model (ASP) there's no requirement on your part for special hardware or network configuration by your IT group or any clinical sites and laboratories. You need browser access and the basic foundation has been laid. To address the issue of having many individuals participate in a multi-site study, EMMES Professionals will help you manage information flow by creating a customized project branded portal with both public and secured spaces so team members are privy to designated information. Prospective subjects learn about the study. In the user defined secured areas PI's, Data Managers, SRB and others you designate can gain access to their information and perform required activities.

Study Design. Using our proprietary tool, Web Form Builder as the foundation for creating electronic Case Report Forms (eCRF), data managers can select from a library of thousands of templates. They can reuse existing eCRF in whole or parts and easily modify business rules and other trial components based on study needs. We employ unique techniques such as Skiplogic creating data groups that eliminate inconsistencies and sophisticated logic with range, cross- field and form checks that render only applicable questions per visit. The final result is a workflow driven capability that maximizes data quality and timeliness.

Protocol Monitoring Module (PMM). Site data audits provide the opportunity for an independent quality review and assessment of the accuracy of collected data versus the source documentation. The PMM is a web-enabled online capability that allows a user to perform and track audit activities. The monitor assesses the accuracy of the submitted data relative to the source documents by comparing them to the system data. Audited data is tracked and stored in a different database. When the data is found in conflict, it is highlighted and moved to the Discrepancy Report.

When a site user logs in, he will see the discrepancies on each form as they are highlighted in red. The user is not privy to the correction the monitor entered but once the data agrees in a field, the red highlight disappears and the correction is reflected on the Discrepancy Report.

Query Resolution Module. AdvantageEDC provides a built-in mechanism for managing missing values on eCRFs. During eCRF creation, designers specify the variables that are 'required' and the conditions when they are excused. When deployed, this intelligence is embedded in the eCRF and is dynamically applied as data is entered. As an additional aid, reports are available to highlight forms with outstanding missing fields. Users will be able to use the report to navigate directly to the eCRF in question. The data that drives the QRM will be shared with other aspects of the project for generating compliance and performance reports.

EMMES MedDRAź Processing System. Developed to normalize the classification, retrieval and communication of information throughout the product regulatory cycle, MedDRAź (Medical Dictionary of Regulatory Activities*) has become the accepted international standard language for drug regulatory reporting. EMMES MedDRA Processing System (MPS) incorporates that dictionary into an auto-encoding system through our AdvantageEDC platform. By using this capability a repository of the protocol's coded Adverse Event descriptions are created in the MPS Knowledgebase that will help you meet international regulatory requirements.

The MedDRA Processing System builds a knowledgebase for your MedDRA coded Adverse Events that adds structure and efficiency to ongoing coding and when creating reports and performing subsequent statistical analysis. Additionally, the service contributes to a streamlined and cost effective approach for managing information dissemination to key stakeholders. Whether your study is for Phase I or IV, the combination of our professional staff and MedDRA Processing System improves the quality of your data for inclusion in reports to the FDA or other international regulatory agencies.    (MedDRAź is a registered trademark of the International Federation of Pharmaceutical Manufacturers Association, IFPMA.)

Standard Reports. In addition to the reports associated with the advanced features above, status reports have been designed to give you snapshots of the studies progress. Standard reports include Accruals by day and month, Missing Data, Missing Forms, Forms entered per Month, and Adverse Events. Because of the flexible underlying architecture, it's easy to customize and provide Statistical or Administrative reports. EMMES Professionals can guide you with more complicated reporting requirements.

To learn more about EMMES Advantage Suite or request a demonstration, email or call us at 301 - 251 - 1161.

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