ARG

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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.

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

The TrialVista interface and relational database are constantly updated, enabling users to take advantage of the latest technological advances.

The adaptable Intuit foundation allows for rapid deployment across any number of users — unlike older CTMS systems, which can take days to load onto a server (and require often arcane IT skill-sets).

It also allows the rapid dissemination of software upgrades, and enables every client to take advantage of modules and features created for other users' trials.

TrialVista features many Windows-based techniques, such as right-mouse clicking, and a familiar web-based navigation system. External users can be using the system within hours of going live. User-friendly translates to less training, fewer support requirements and reduced expenses.

TrialVista's deployment can be measured in days, not months. Because it's web-based, there's no need for implementation on individual PCs scattered between sites. And because updates are handled automatically at our end, there's always the assurance that every user has access to the most current version of the software.

All of which means clients can immediately begin realizing a return on their investment. With trials often costing tens of thousands of dollars a day, this can be a key factor in achieving commercial priorities.

TrialVista gives users access to a wide range of reports, customized to their specific needs. With near instantaneous reporting, users can have the information they need when they need it.

Our vast array of standard reports is complemented by ad hoc reporting options, which allow users to access, consolidate and distribute exactly the trial data that's most important to them.

TrialVista's remote monitoring tools allow for effective and efficient monitoring — an absolute necessity for any viable CTMS.

Our CRAs access any relevant trial and site data prior to a monitoring visit and can make updates in real time throughout the visit. This allows Project Managers and Lead CRAs to evaluate site visit data without the delay of a paper-based reporting system, which can often take weeks.

Errors are easily reviewed and corrected, further optimizing CRA time. Projects requiring multiple CROs can take advantage of TrialVista's standardized tools, which are easily implemented across third party vendors and eliminate the confusion of multiple management systems.

TrialVista interfaces with the latest technology solutions required in clinical trials, including Integrated Voice Response Systems, Electronic Data Capture and Clinical Data Management. Compatibility with the Microsoft Office suite and third party shippers' software can further centralize trial management from drug supply to timely investigator payments.

The ability to import data from these systems lets users create a real-time comprehensive view of trial progress. This ensures up-to-date reports and trackers for trial personnel.

ARG realizes the strain that older CTMS systems, and the requisite on-site support they entail, can put on client's IT infrastructure and bottom line

That's why we designed TrialVista to be a cost-effective alternative to local implementation and support staff. The entire infrastructure resides with ARG, and we're responsible for all upkeep and upgrades. And we provide unlimited technical support throughout the course of the trial, eliminating any worries about technology getting in the way of progress.

Clients are faced with CTMS costs that can vary from hundreds of thousands to several million dollars. How can they know which one is right for them?

TrialVista makes the choice simple.

It provides the management tools inherent in a top-of-the-line CTMS, without the high price and support costs that keep them out of reach of smaller pharmaceutical or biotech companies.

Our license model allows for concurrent internal and external users with varying permission levels, customizable to the client's needs. Costs are significantly less than the named-user model, in which additional users and turnover rates can increase the price exponentially throughout the life of the trial.

Since it's a modular system, sponsors can purchase only the components they need for a particular study. And its architecture makes it easy to create and deploy custom modules designed to meet specific trial needs.