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    EDC Services

Comprehensive study design and execution

OmniComm offers complete hosted SaaS engagement whereby OmniComm will designate a dedicated group of clinical and technology professionals to work closely with your team to design and build an EDC database that accurately matches the characteristics of your study design. Our approach provides the best experience for your end users, while allowing for rigorous data validation, flexible reporting and quality data extractions. OmniComm’s EDC services associates are industry professionals exclusively focused on effective study build and delivery.

Project Management

 A project manager will be assigned to oversee all service delivery, taking you step by step through the study development process. Your project manager will document all activities, provide you with a detailed project plan and coordinate all correspondence and meetings throughout the process. Your project will commence with a formal kickoff meeting followed by weekly status calls and clear communications throughout the duration of your study. We use a methodology called OmniAdvance to ensure that all of your deliverables are standard and high quality.

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Clinical Services

Our clinical team has expertise in translating a study protocol into an intuitively designed data capture system that accurately meets the requirements of your study while optimizing the design for the highest end user compliance. We will develop a complete Trial Design Specification (TDS) to fully document the design elements of your study database. Our team will ensure that CRF design, Event Schedule, Site and Patient definitions, Edit Checks, Derivations, and Code Lists are all optimized to use industry best practices, and where applicable CDISC/CDASH standards. OmniComm’s team of study developers uses an incremental approach to ensure that you have early review phases and testing opportunities. Our approach ensures timely study build cycles, improved quality, and the opportunity to leverage our experience and knowledge of industry best practices. Before providing a study to the customer for User Acceptance, we take it through a rigorous clinical review and quality assurance cycle.

Customer Training

OmniComm provides a comprehensive training curriculum to ensure that customers have a thorough understanding of the many features available to them. For new customers, we provide Orientation Training that delivers a series of instructor-led online sessions including TrialMaster software overview, design specifications, report writing, autocoding, UAT training, and administrator training.
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Deployment

Our deployment and integration engineers are experts at publishing your studies to our secure server environment. They will ensure that your study as well as any OmniComm tools or 3rd party integrated solutions (e.g. IVRS, ePRO, eLearning, Ad-Hoc Reporting) are ready for use and operating as expected.

Archives

Archives are a critical deliverable to ensure compliance for all involved parties. OmniComm’s archive service provides a high-quality submission-ready archive containing all expected elements such as hyperlinks and bookmarks.

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Global Customer Care

Our 24 x 7 Global Customer Care team is always available to ensure that any questions or concerns are expeditiously addressed. All of our agents are OmniComm employees, committed to providing high-quality customer care services.

 
The Essential EDC Partnersehip Strategy
for Ensuring Study Success
How Your EDC Specialist can Change Your Study Outcome

Contact Us      North America +1 877.468.6332      Europe +49 (0) 228 227 440      Click Here to Email Us

Contact Us
North America
+1 877.468.6332
Europe
+49 (0) 228 227 440
Click Here to Email Us