Interactive Web/Voice Response System for Clinical Trials
The Trident Interactive Web/Voice Response System bridges the gap between clinical trial sites and supply chain management while speeding up the setup, testing, and deployment of new protocols. Trident easily performs subject randomization, determining the treatment arm for each patient in the study and tracking clinical information. Drug dispensation can be tailored to a variety of visit-specific strata so that even the most complex dosing schemes are easy to manage. As drugs are dispensed, Trident clinical IWR/IVR can be configured to track supplies and ensure that investigator sites stay fully stocked with the supplies they need to participate in the study without expensive waste. Trident IWR and IVR for clinical trials makes it easy to track and report on multiple studies and helps sponsors take advantage of money-saving features like drug pooling.
With an easy-to-use interface and robust functionality, Trident is the right IWR/IVR for every clinical trial situation.
Faster Start Up for Complex Studies with IWR/IVR for Clinical Trials
As the world’s leading parameter-driven IWR/IVR, Trident makes it easy to quickly set up, test and deploy new protocols so trials can start in weeks instead of months. Trident’s parameter-driven design means little or no system development is typically necessary to set up a trial. Learning from years of experience, Trident clinical IWRS/IVRS anticipates the needs of each trial and presents options that allow for faster configuration. There is no separate setup process for voice and web – the voice component is integrated into the web system. With a shorter specification document and streamlined configuration process, Trident is the IWR/IVR solution to launching complex studies without delay.
Trident was built to accommodate the needs of the user and is designed to be fast and flexible. While the parameter-driven model streamlines the configuration process, Trident does have the ability to add custom code and functionality through pluggable programming.
Subject Randomization
The primary function of Trident interactive web and voice response system is to meet the specified distribution of study subjects across all treatment arms in a clinical trial. Once subjects are entered into the system, Trident randomizes them into a treatment arm and tracks their clinical information for the life of the study. This information can be kept blind from the investigator to prevent bias or influence. Trident IWR/IVR is designed to handle the complex dosing scenarios that can come into play with modern clinical trials and is able to support a number of blinding methods including open blind, double blind, third party blind, and blinded treatment group.
Drug Dispensation
Trident can be configured to define a variety of dosing factors, including those based on visit-specific information such as current weight. Trident IWR/IVR for clinical trials makes it easy to dispense investigative compounds while maintaining confidentiality by instructing the investigator which numbered drug kit to dispense based on the designated treatment arm. Based on the blinding scenario, the investigator does not know if the patient is receiving an active drug compound or a placebo.
Robust Functionality
There is no such thing as a simple clinical trial. Trident was built to handle the complications that arise during the course of every drug study. Trident features the usual IWR/IVR features such as cold chain support, drug accountability, adaptive study design, built in alerts and notifications, and system integration. It’s the advanced features of Trident make it possible to support even the most complex trials.
- Minimization: Trident IWRS/IVRS uses an advanced algorithm to randomize subjects into treatment arms based on minimized imbalance as opposed to traditional blocking methods.
- Site-To-Site Shipments: If a site is running low on supplies, project managers can use Trident to identify surplus materials and route them from one site to another while maintaining the audit trail.
- Re-Randomization: Manages can identify a future visit when a subject will be randomized into another treatment arm, such as another phase in the study.
- Withdrawing Visits: Lowers dosage amounts so subjects are weaned off investigative drugs over a set period of time.
- Drug Pooling: A single database allows for sharing of supplies across multiple studies in Trident.
- Replacement Subjects: if a subject with certain criteria drops from the study, you can randomize another subject into that criteria group while maintaining subject balance.
- Extension Studies: Move subjects from one study into another based on specified qualifications.
- Branching Logic: Trident IWR/IVR makes it easy to ask the right questions by creating an advanced "question tree" that collects information based on specific questions and criteria.
- Integration: Trident is designed to work hand-in-hand with Optimizer, the supply forecasting tool that easily creates trial simulations for a wide variety of scenarios, and to feed data into Express, BioClinica’s electronic data capture system.
