eClinical Differentiators

Product Brochure

Differentiators

Click here to see what sets the eClinical Suite apart

U.S.A. +1.954.473.1254
Intl. +49 (0) 228.227.4422
Click here to email us

eClinical Suite Differentiators

What Makes the eClinical Suite Unique

Whether you are a pharmaceutical, device, biotechnology, academic or government institution, the OmniComm eClinical solution is a proven system for large scale global projects or single site Phase I studies.

	OmniComm eClinical Suite	Other Systems
Support for Traditional Paper-Based Data Entry	Paper-Based data entry for clinical trials. Traditional Double Data Entry and reconciliation. Supporting sites without the capability of EDC. Supporting hybrid trials, fully integrated with EDC clinical database.	Double data entry phased out. Limited integration with clinical database.
Library System for Fast Study Build	Global (including CDISC CDASH) and Clinical Program library for building and validating studies in compressed timeline. Fast build for data entry screens, edit checks and clinical database.	Limited library features for full support of edit check functionality
Rapid deployment for mid-study changes	Mid-study changes deployed rapidly to production systems using validated systems	Mid-study changes requiring programming and deployment support
Complete Technology Transfer to Client	Systems for developing studies for EDC or Paper-based systems deployed in-house on client’s technology	Most systems required hosting with the vendor
Fully Integrated Suite of eClinical Solutions	OmniComm’s eClinical Suite is fully integrated for data entry, monitoring, data management, autoencoding, reporting, clinical trials management (CTMS) and safety reporting for SAEs to regulatory authorities.	Many data management and EDC systems offer interfaces to other systems, generally these are not fully integrated.
Configurable screens	The portal and EDC systems are fully configurable for look-and-feel, summary screens and metrics. The terminology is full configurable to facilitate studies for drugs, devices, diagnostic instruments, and animal studies	Most systems have static screens. Other systems do not provide for configurable terminology.
Integrated Autoencoder	An autoencoder for coding terms and drugs against MedDRA, WHODrug and other user-defined dictionaries (e.g. NCI) is fully integrated into the system	Autoencoder systems are generally externals to clinical systems and may be interfaced.
Clinical Trial Portal	The eClinical trial portal enables users to see a real-time snapshot of the clinical trial, metrics, reports etc. using fully integrated security to the eClinical EDC, data management, CTMS and safety systems.	Limited commercial clinical trial portals are available. Interfaces and integration to data management, CTMS and Safety Systems are required to be setup.
Safety Systems for SAE / SUSAR Reporting	Safety reporting systems for reporting SAEs / SUSARs to regulatory authorities including the FDA, and providing CIOMS reports.	Safety Systems provide reporting for the regulatory authority requirements, interfaces and integration to data management systems are required to be setup.
CTMS – Clinical Trial Management System	Fully integrated clinical trials management (CTMS) for managing patient enrollment, finance, regulatory compliance	CTMS systems provide clinical trial management support, interfaces and integration to data management systems are required to be setup.