ePharmaSolutions’ Study Management tools help study teams manage and track clinical study sites, and vendors manage many study management tasks reducing the amount of time and data entry typically required of traditional technologies.

UMA/VIM—User Management Application and Vendor Integration Manager
The UMA is a configurable application that allows study sites to maintain a single study/site user profile throughout the study with programmatic distribution to each vendor in the exact field format structure they require. The concept is to be able to add or edit a user so all selected vendors on a study automatically receive the update in the format they need. To view a demo, click here.

eMVR—Electronic Monitor Visit Report
The eMVR makes the process of tracking monitor visits simple and seamless for monitors and study managers. Reports can be auto-populated with site information and past follow-up items, can be completed on or offline, and have an electronic signature to meet Part11 requirements. To view a demo, click here.

SDE—Secure Document Exchange
The SDE is the pharmaceutical industry’s leading study document exchange technology that supports the negotiation, completion, and digital signature submission of regulatory, study-specific, and contractual documents that are required for study start-up and maintenance. To view a demo, click here.

eTMF—Electronic Trial Master File
The eTMF was developed in SharePoint 2010 and architected specifically to support enterprise and study-specific automated deployment with secure externalization through ePharmaSolutions' Clinical Trial Portal applications. This externalization provides full electronic document lifecycle management from initial template approvals through site signed documents. The eTMF supports intelligent document uploading, bar-code scanning with fax-back, and electronic/digital signature and provides study teams with robust search and reporting (missing documents, expiring documents, completed documents, etc). Click here for a brochure.

SLD—Safety Letter Distribution
The SLD is the industry-leading application used to notify sites and IRB/ECs of IND Safety Reports. The application was developed to support the regulatory considerations of studies conducted in more than 90 countries.

LMS—Learning Management System
The LMS develops, deploys, and tracks all study-related training and certification via online self-paced eLearning modules, online webinars, or in-person meetings with a full audit trail for compliance purposes. To view a demo, click here.

PRM—Patient Recruitment Manager
The PRM is used to plan and track patient recruitment/retention plans from the start of the study. The PRM tracks recruitment at the study, country, and site level, and tracks projected vs. actual enrollment through a seamless IVRS integration. The PRM includes an IRB/EC approval tracking system and a Material Manager and Outreach Tactic tracking mechanism. To view a demo, click here.

SMS—Study Messaging Services
The SMS allows study teams to quickly configure a patient retention campaign using ePharmaSolutions global 2-way texting application. In a matter of days, the SMS can be configured and launched to support an entire global study. To view a demo, click here.

For more information or to contact ePharmaSolutions click here.