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Ten Big Questions to Ask Your Clinical Transparency Solutions Provider

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M A K I N G T H E C O M P L E X S I M P L E TrialScope, Inc. | Harborside Financial Center Plaza Five, Suite 2900 Jersey City, NJ 07311 | 877-658-8310 | www.TrialScope.com Clinical trial disclosure is a complex and dynamic process. When considering clinical trial disclosure solutions, it is important to understand the potential partner's practical experience and how their solution fits your compliance needs today and in the future. Following are ten big questions to ask your prospective solution partner. Ten Big Questions to Ask Your Clinical Transparency Solution Partner 1. What is the real solution package that the vendor is selling? (Is it a comprehensive package that includes software, subject matter expertise and best practices for registries (such as EudraCT and Clinicaltrials.gov)? Or is it simply a technology solution? Ask for a specific list of what is included in the annual subscription fee and make sure these items are included in your contract.) TrialScope offerings are software solutions powered by years of industry experience. Out solutions are found on industry best practices and unparalleled subject matter expertise. They include ongoing access to industry leaders and subject matter experts because technology alone is never the best answer. Our Rapid Path to Compliance engagement methodology ensures that clients get the most from their investment—a comprehensive package of software supported by expert services. We are a solution partner and we take both words very seriously. 2. How many clinical trial disclosures (registrations and results reporting) has the vendor managed? (Determine how many customers, users, and trials are being managed with their solution. Check whether they have been displaced by a competitive product, either during the implementation phase or once in production.) TrialScope solutions are used by 6 of the top 10 clinical trial sponsors. Almost 8,000 users are managing close to 30,000 clinical trial registrations in PharmaCM. PharmaCM has never been displaced by a competitive product. In fact, four TrialScope customers chose PharmaCM to replace competitor products either because of failed implementations or because the vendor was unable to sustain the development needed to keep up with the evolving regulatory and registry requirements. Additionally, four TrialScope customers replaced custom solutions to reduce the total cost of ownership while gaining access to a more robust and up-to-date solution. 3. Does the vendor have global regulatory monitoring capabilities? (Do they have a process and track record of proven success for monitoring regulatory requirements and for modifying system capabilities to provide updates on a timely basis? This is where you learn about the vendor's product vision, subject matter expertise, their responsiveness to constantly changing global requirements and their commitment to regulatory monitoring.) TrialScope monitors emerging registrations requirements and keeps current with the latest changes on EudraCT and Clinicaltrials.gov. For example, we recently responded to a change on Clinicaltrials.gov's PRS system with our own update (developed, tested and deployed) within 5 working days. We also bring first-in-industry solutions to the market such as TrialScope Convert, a free online service for converting clinicaltrails.gov results XML files to the format required for EudraCT result reporting.

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