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Clarix provides the most advanced fully web-integrated IVR system in the industry. Our web-hybrid IVR system provides users with an unparalleled level of functionality both over the phone and the web. The Clarix web/IVR system integrates seamlessly with our web-based project management tools, giving you a centralized control center for managing your entire study, or multiple studies, in real-time.
Clarix IVRS Highlights:
- Rapid deployment: 4 - 6 weeks depending on complexity
- Every system is fully web-integrated
- Designed from the ground-up to be 21 CFR Part 11 and GCP/ICH compliant
- Pre-validated modular systems with simpler randomization schemes for smaller/early-phase trials
- Expertise in adaptive randomization techniques and complex dosing algorithms
Our phone and web-based supply chain monitoring allows real-time, global tracking of drug supplies by investigator, lot number, expiration date or any other parameter you choose. Our web-based tools automate the drug ordering process and allow you to adjust, on a site-by-site basis, variables such as:
- Trigger and buffer supply levels
- Time windows for projected patient visits
- Projected randomization rates
- Projected up and down dose titration rates
Clarix systems provide you with the ability to "pool" your drug supply and kick off a trial with a minimal amount of drug inventory.
Implement complex randomization schemes
To ensure proper treatment arm balancing in blinded and open-label studies, Clarix allows you to easily implement complex randomization schemes such as:
- Blocked multi-factor stratification from centralized static lists
- Adaptive balancing algorithms using random number lists
For blinded studies, our solutions automate the randomization process where patients are dynamically associated with treatment arms, assigned patient identification numbers, and issued medication kit numbers based upon available site inventories.
For adaptive algorithm and multi-factor stratification studies, Clarix can perform predictive randomization simulations to help you anticipate the balancing results in your study.
Investigative site supply management
Site supply orders, which are automatically generated and transmitted to the supply depot, are based upon parameters that are set by you. These parameters such as trigger level, buffer level and visit projection window may be adjusted as needed during the course of the study and are monitored online either by you or by Clarix. This flexibility allows "just-in-time" supply delivery and reduces costs by minimizing drug wastage and the number of shipments required for each site.
Supply-chain forecasting
Manage global supplies across multiple protocols using our supply-chain forecasting tool. Using a predictive model of study simulation, our forecasting tool determines with superior accuracy the dates when current supplies will be exhausted at the supply depots and investigative sites in each protocol. Through our web interface, you can see how these dates can be affected by hypothetical scenarios such as new lot availability, depot-to-depot transfers, expiry date extensions, and new patient randomization rates.
All of this allows you to answer your two most important global supply questions:
- How much new supply is needed?
- When does the manufacturing or acquisition process need to begin?
Have tight, yet flexible, control over study site operation
An investigative site administration module is available in our web-integrated IVRS. Site activation, de-activation, suspension etc. can be done over the phone or on the Web. Site activation can be made to trigger an initial clinical supplies shipment, site user access code activation and site personnel notification by fax, or e-mail. Sponsors have the ability to also de-activate or suspend sites using the IVRS or the web.
Utilize centralized unblinding
The Clarix IVRS systems allow you to do an emergency code-break in the event of an emergency. The system can also automatically alert you of an unblinding in a variety of ways including a phone call, fax, e-mail or page so that you can promptly follow-up with an unblinded patient. Only specified study participants are allowed access to the unblinding feature. All access is controlled with multiple unique passwords and roles based access controls, ensuring that only authorized study personnel have access to critical system functions.
Collect up-to-date patient diary information and make patient diary data a valuable analytical tool
In a traditional trial, obtaining accurate patient diary information can take weeks, if not months. By the time accurate diary information becomes available, you may have missed important opportunities to make adjustment to the trial. With a Clarix IVR systems patients have access to a toll-free telephone number to dial in and enter the requested data. Significant events, such as adverse effects and deviations from protocol, are flagged for quick follow up. Our IVRS based patient diary solutions have demonstrated compliance levels greater than 90%.
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