Trifecta is a firm of creative technicians and project managers who specialize in the development of customized and innovative online solutions for pharmaceutical and biotechnology firms in pursuit of well trained, documented, and compliant clinical trials. Trifecta built its proprietary technology, InvestigatorSpace®, and all of its features and solutions, entirely in-house. We have provided support for clinical trials globally for the past 12 years, with delivery of training and online document support and reporting for clinical trials in more than 100 countries. Our clients include CROs, pharmaceutical companies, and biotechnology firms. Our differentiator is our ability to work closely with our clients and to customize solutions for each sponsor and the needs of an individual clinical trial and study sites involved.
Trifecta’s InvestigatorSpace® portal is a custom technology platform, developed entirely in-house, that provides audit-ready documentation from the trial start-up phase through study close-out. The InvestigatorSpace® training and communication portal powers clinical trials to accelerate site readiness. The Study Home landing page allows sponsors to communicate important information and messages to the study community, and to deliver documents, training and safety letters via three specific solutions that ensure compliance with the U.S. Food and Drug Administration (FDA) and The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulations. The features of InvestigatorSpace® simplify, streamline, and reduce the administrative burden of the clinical trial process for sponsors and study teams. Information is easily accessible, housed in one secure online location, and reportable.
InvestigatorSpace® Study Home is the landing page for all site and study team staff. It gives sponsors the ability to communicate with study personnel around the globe, with easy-to-use administrative features that enable delivery of real-time messages and information. Study Home features include study calendars, team profiles, videos, critical links for information, a document repository and an area in which sponsors and study teams can communicate. Study Home also displays study personnel tasks and outstanding training requirements to ensure all personnel are notified when they are not in compliance.
SafetyVigilance® - Safety Letter Delivery (an InvestigatorSpace® feature) is the secure electronic delivery of safety letters. SafetyVigilance® has a simple workflow: report, document, distribute, verify, archive, and close. Clinical sites can access letters directly via email or via the InvestigatorSpace® portal. Study team can assign letters as read-only, e-signature required, or e-signature not required. Study teams are able to enable country- or region-specific reporting making configurations easy to generate and maintain with minimal time investment. Letters can be downloaded, printed, and emailed with the click of a button.
Regulatory Document Exchange (another InvestigatorSpace® feature) is a fully automated work flow system for the distribution, tracking, and collection of documents related to study start-up. Site Ready accelerates the completion of the regulatory document exchange process, eliminating paperwork, shipping/mailing costs, and the tedious back and forth of communications. Site Ready centralizes and displays current document status for all sites, provides total document version control, alerts sites to actions required and completion status as well as generates an audit trail tied to each document and action.
Investigator Training can be delivered via three different solutions. Study teams can choose one solution or can combine all three to ensure that both compliance and comprehensive training is achieved. On-demand training is delivered on the InvestigatorSpace® portal and is role-based. Trifecta has the creative and technical talent to capture training modules and collaborates closely with clients to ensure training, and all online solutions, are customized to sponsor and trial needs. Each training module is loaded and assigned based on a user’s role in the study. Study team personnel may then access their unique training and complete training at their discretion. Trifecta uses a proprietary Watch Code feature to ensure that study personnel remain engaged during training, i.e. if a user walks away from his or her computer during training, the session will suspend until the user enters a code to re-initiate training. Live Web-based investigator training meetings are also accessed through InvestigatorSpace® and delivers content in a live virtual meeting setting. All users log into the meeting with their specific credentials, and speakers deliver content real time through a branded web-based platform. The web meetings can display video, audio and slides or a combination of the three. Polling questions are used to keep the audience engaged and all attendees’ log-in and log-out times are recorded for training certification. Live investigator training/Site Initiation Visits are on occasion still the best solution for training clinical sites. Certificates of Attendance are available through InvestigatorSpace® portal which enables study teams to certify training and houses training records in one central location. The live meeting may also be captured and posted online to ensure training is delivered for site and study team turn over.
The Compliance and Certification Directory (CCD) (another InvestigatorSpace® feature) allows for Training Exemptions for your trainees. Trainees are able to apply for a training exemption based on training topics. The trainee is able to upload active training certificates from other sources and your study team will be able to exempt him or her from training modules they have been assigned, if appropriate. This eliminates redundant training for sites and ensures comprehensive training records.
Director, Business Development