FAQ: Navigating Your Queries

eTrialX is a clinical trial management solution focused on helping sponsors, CROs and other vendors with study management. eTrialX offers a comprehensive solution for all study management components so there is no need for a CTMS, EDC, or eTMF integration since all the components are built within the same platform. As a client, you will have the option to access the solution via browser, mobile device, or Desktop Client. The solution can be either a cloud-based service in which our team can take care of hosting and system management, monitoring and maintenance, or it can be installed within your domain.

Yes! Build, capture, and report on your clinical data with ease. eTrialX’s electronic data capture (EDC) module is included within the solution. We automate electronic data capture (EDC) with dynamic, comprehensive electronic case report forms (eCRFs) for clinical trials, enabling researchers to collect better data, faster, and efficiently. In addition, our solution allows CRAs to easily review data remotely, submit Data Queries, manage Protocol deviations, and collaborate with site personnel.

Yes! eTrialX eTMF module is included as an essential feature of our solution. All documents are accessible and automatically organized as you navigate across the different parts of the solution (Site documents, Financial documents, etc…). Documents can be imported from as Fax, email, scan, and more… Additional features include:

• Automated Document Retention

• Text Search

• A single place to share and collaborate on clinical documentation

• Author documents by opening MS Word®, Excel®, and PowerPoint® directly from the interface, and using the Collaborative Authoring tool for editing and review by multiple team members.

• Align document work streams with regulatory compliance practices for document authoring, approval, control, and related training.

• Complete the end-to-end process with electronic signature for document approvals – 21 CFR Part 11 eSignature compliant

No matter where invoices arriving at your institution originate from, we capture them at the source and send them to one, central location for processing. Regardless of invoice format – mail, fax, email, EDI, etc. – we will automatically extract relevant data and deliver the invoice images and data directly to your accounting, enterprise resource planning (ERP) and content management systems. The data is validated using business rules, database lookups and sophisticated algorithms to ensure accuracy, speed the invoice cycle and remove the risks associated with manual data entry. This results in much faster invoice processing allowing you to resolve exceptions sooner, take advantage of more early payment discounts and handle an increasing number of invoices without the need for additional resources.

• Central IRB Approval for Easy Submission

• Create Essential Documents and Submission Packages

• Estimate/Track Deadlines, Predict Site Activation Timelines

• ID Missing Documents and Statuses

• Protocol Amendment

• Forecasting and Oversight Dashboards and Reporting

• Identify Mitigating Factors Delaying Site Approvals

• Get Alerted to Top Sites Ready for Activation

• Distribute and Submit Regulatory Packages

• Regulatory Review Workflows

• Track Submission/Approval Statuses

• Milestone and Task Management