Jim Pedzinski, VPMost companies running clinical trials, like most businesses, are trying to increase their efficiency while cutting costs. Prelude Dynamics, based in Austin, TX, is one of the leading companies in the industry to help them do both. Prelude was created specifically to help companies streamline processes for both veterinary and human clinical trials. Prelude works with university research groups, medical device companies, single-site animal health organizations, multi-national Contract Research Organizations (CROs), and pharmaceutical companies to create systems and services that improve their clinical trial efficiencies. Prelude’s unified platform and clinical data tools help our Clients manage trials “work smarter, not harder with processes and tools that enable more efficient day-to-day operations,” according to Vice President Jim Pedzinski.
Prelude was founded by Richard Tieken and Alicia Browner, Ph.D., former NASA and Lockheed Martin engineers with more than 60 years of experience developing software applications used in clinical research. Seeing the need, they created a fully integrated software platform called VISION™ that meets all the needs of a company’s clinical research agenda from Phase 1 through post-market registries.
VISION is the only Clinical Trial Optimization Platform (CTOP) available in the industry. The VISION platform compresses cycle times for clinical R&D programs, and provides more confidence in the data collected and enables faster submission to regulatory agencies for approval. Clients can design their own studies or use it as a full-service solution, selecting the functionality and service level needed for each study. Also, because it is a fully-integrated platform, clinical teams can easily change requirements from one study to another using the same forms from study to study, allowing standardization across programs, all while receiving the highest quality support.
The VISION platform integrates the features of the best electronic data capture (EDC) in the market with clinical trial management system (CTMS) and clinical data management system (CDMS) functionality giving clients the ability to build their own study or leverage Prelude’s full service support in building the study on their behalf. Because they can build their own study using VISION, clients who need a solution for smaller, shorter duration studies have found it very cost effective. VISION was built from the ground up to provide this integrated level of service and choice of implementation rendering a unique offering to the industry.
No other platform provides a continuum from DIY to full service without having to recreate studies from scratch. The VISION platform consists of VISION Composer, VISION Premium, and VISION Pre-Builts.
VISION Composer provides the “Do-It-Yourself” capability. Using Composer, a client can build electronic case report forms (eCRFs) with ease.
Alicia Browner, FounderUsing drag-and-drop modules an eCRF designed through Composer is completely configurable based on the entry fields, checks, and calculations required for any clinical study. With VISION Composer, users are able to develop quality EDC solutions quickly and with minimal training. Composer also comes with functions such as just-in-time randomization, inventory management templates, invoicing, document management, statistics, graphing and reporting just to name a few.
VISION Premium is the full service portion of the platform. EDC capabilities are configured to allow the collection of specific study data, complete with edit checks or automatic queries, calculations, and other complex logic. Premium provides a full suite of CTMS functions such as just-in-time randomization, inventory management, invoicing, lab processing, document management and much more. Summaries, ad-hoc reports, descriptive statistics and graphing provide both remote monitoring/adjudication and unequalled CDMS functionality. Premium not only collects data, but also streamlines tedious work, like inventory management and invoicing by integrating these critical functions into the natural work flow of monitoring— freeing up valuable time to be spent doing other critical study tasks.
Beyond helping, we let clients take a dive at a ‘do it yourself (DIY)’ model
For studies that are repeated frequently, Vision Pre-Builts, are an excellent solution. These template studies leverage a one-time study build and can be used infinitum. Forms are built in modules that can be activated as needed depending on the study. Study set-up when using Pre-Builts is achieved rapidly, oftentimes in less than an hour.
Mr. Pedzinski concluded, “VISION CTOP is a fully-integrated solution designed to meet the needs of any protocol workflow allowing clients to expertly manage phase 1 to post-market studies in a single, unified platform. Additionally, SOPs, eTMF, site management and study management can all be handled, making it an apt solution.”
Prelude is constantly looking at new tools, technologies, and ways to implement them into the clinical trial environment and is also exploring how AI might be best integrated into VISION in the future.