The TrialVista® architecture is based on a modular design, which allows for rapid and economical customization to precisely meet individual study needs and reduce start-up costs.

Project Management

Provides the central location where Project Managers can organize their projects, and where team members, partners and clients can go for the latest details and status updates. Instead of purchasing costly Microsoft Project® licenses, teams can use a simple common interface to:

• Organize Projects and Track their Progress
• Delegate Tasks
• Monitor Progress and Upcoming Deadlines
• Notify Team Members of Changes and Assignments Automatically
• Track and Enforce Date Dependencies Between Related Tasks
• Generate Project Reports - Charts, Timelines, Calendars, etc.

Patient Management

Manages patient screening, enrollment and dosing, while tracking a potential subject's chart review, screening visit and patient consent.

Prospective patients can be added to a watch & wait list, with automatic emails used to remind site personnel to follow-up on the patient's eligibility. The module is built to match specific patient inclusion criteria. Sponsor, CRO and all study personal can be notified of potential patients by automatic emails. Sites can be prompted by automatic emails to enter weekly patient screening logs, even if no patients are screened. The module tracks patient visits, labs, patient dosings, SAEs and all protocol exemptions and violations. All relevant regulatory data regarding patient visits can be tracked, and automatic emails can notify sponsor and all study personal of patient visits. This module works seamlessly with the Investigation Product (IP) Management modules, as each site's IP inventory is automatically updated when a patient is dosed.

Regulatory Document Management

Tracks all essential and non-essential regulatory documents, by site — including the Clinical Trial Agreement (CTA), Confidential Disclosure Agreement (CDA), and site assessment.

Also includes a regulatory status summary for each site. All 1572s, Investigative Brochures, Informed Consent, CVs, IRB Approvals, Financial Disclosures, Protocol Signature Pages, Principal Investigator documents, medical licenses and laboratory documents are managed from this module. Also tracks negotiation and contract status, as well as site activation status of each investigative site.

Documents are available online making them accessible to all study personal and allowing for automatic distribution. Automatic emails are used to notify study personal of expired, and about to expire, documents.

Monitoring Visits and Reports

Contains all monitoring reports as well as correspondence regarding monitoring visits — Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close out Visits.

The module tracks notifications and alerts corresponding to the regulatory document database and any ancillary tracking with regards to monitoring visits. It also contains the Action Item log that tracks and monitors items that need attention. All reports are completed, submitted and reviewed online. Automatic emails are used to track and manage the monitoring report process.

Investigational Product Management

Tracks, reports and manages all aspects of Investigational Product.

It allows the sponsor and CRO to efficiently manage site requests and inventory, vendor inventory, shipment, receipt and re-order of all IP. Shipments can be tracked in real-time and automatic email notifications are used to inform sponsor and CRO of IP receipt. Sponsors can get real-time inventory of each site and track usage in order to accurately project IP usage over the entire life of a trial.

Investigator Database

Provides centralized management of all investigative sites used by the sponsor.

The foundation for all clinical trial protocols, where detailed contact info, specific study participation, Institutional Review Board (IRB) details, Principal Investigator (PI) and sub-PI details, and clinical laboratory information are managed for each site. The Site Feasibility Questionnaire (SFQ) is also incorporated into this module. Potential sites can easily complete the SFQ online and responses are available to the sponsor in real-time. Essential regulatory documents can be automatically generated by harvesting information from the SFQ. The Contact Log tracks all communication between site, sponsor, CRO and ancillary vendors. The Investigator Database provides easy access to all contact information for sites, vendors and study personnel.

Patient Recorded Data

Enables patients to log in and complete study-specific diaries and surveys online at their convenience. Team members are automatically notified when a patient enters a diary and can view the results in real-time. Study Coordinators will also be better equipped to manage the completion of these surveys as reports and automatic reminders can be used to make sure the data is recorded in a timely manner.

Central Document Repository

Houses all forms, templates, SOPs & images, where they are easily accessible by all study team members.

Vendor and Team Contacts

Includes all associated vendor and team contacts for a specific trial.

Information can be accessed for use across multiple trials and phases. Contact Logs can be added to track all communication between vendors and team members.

Study Q & A

Contains and documents all questions and answers related to the study, allowing for clear communication and dissemination of study-related questions and answers.

Request Manager

Manages and tracks all technical and system administration requests.

Basic report generation, email notification set up and general help request are all easily managed and tracked. Allows for quick and easy resolution of technical and help requests.

Custom Module

Our experienced clinical trial management system developers can quickly develop a module to track and manage whatever information is important to your trial.