Using a Clinical Trial Optimization Platform (CTOP) provides all the benefits of the best Electronic Data Capture (EDC) technologies while also streamlining day to day operations. By going beyond EDC with a comprehensive suite of tools developed to reduce the time it takes to carry out length study management task, Prelude Dynamic’s CTOP is the perfect solution to help reduce waste in research budgets and keep the study timeline on track and even shorten it.
Prelude listens to and understands its client’s pain points in order to continuously develop solutions that will make their studies run more efficiently, make monitoring easier, and ultimately allow data to be cleaned as it is being collected so that once the last patient completes the study, the time to study close is minimal. Many of our clients are locking databases within weeks of the last patient completing the study and are archiving their database the following month. This speed represents a huge cost savings and provides a competitive advantage by allowing the FDA approval process to begin sooner.
CTOP empowers clients to monitor their studies more efficiently by providing standard tools including efficient custom dashboards, integrated query monitoring strategy, access to enrollment information, custom and standard notifications, and mid study analysis tools such as ad-hoc reports, graphing and statistics. As well as, premium tools including just-in-time randomization, inventory management with automatic reordering, invoicing, and document management
Efficient custom dashboards allow users to quickly gain valuable information at various levels. At the patient level, easily filter by sites, create custom filters to view only patients meeting certain criteria for example, only enrolled patients, only females or only males. Sort the data by any column in order to find a patient by patient ID or to quickly find the unresolved queries. A quick look at the form state graphics gives immediate information as to the form states letting monitors know how far a patient has progressed. You can also sort by next event or next event date to identify upcoming work load.
Integrated query monitoring strategy quickly provides monitors with instant information about the state of queries. A query graph shows each site’s total and unresolved queries side by side so it is easy to see if a site is having more issues than another. Two query summaries provide details about the time since the query was entered until it was resolved. Select the query to be taken directly to the field where it is located; after reviewing it click to quickly return to the summary. No need to create reports; these standard summaries are included.
Quickly find unresolved queries on the dashboard by sorting the patients by the query column. Click the query to navigate to it. Within a patient, query icons located on tabs show the state of the query and help users navigate to fields with queries. A query tab lists all the queries for that patient and allows users to respond in line or click to go directly to the field. One more way in which CTOP accelerates a monitor’s work.
Access enrollment information at a glance by using study-wide or site specific enrollment graph which displays the expected enrollment versus actual enrollment or view the information in table format. This information quickly lets you know how your recruitment efforts are going and whether additional marketing campaigns or incentives are needed to keep your study recruitment on track.
Custom and standard notifications ensure both study management personnel and sites are notified of important information so they don’t miss taking action in a timely manner. For example, notifications are sent to sites when lab results have been uploaded into the system to remind them to review the labs results. Sponsors and project managers receive standard notifications when a patient is enrolled, terminated, or completes the study. Prelude project managers work with clients to determine the best strategy to employ notifications for their study to ensure timely information is provide as pertinent.
Just-in-time randomization provides clients with the same algorithms they can expect to get from a statistician who develops a randomization table. The big differences: 1) the treatment is generated when needed eliminating accidental unmasking by a printed randomization table, 2) if a patient is accidentally given the wrong treatment, just-in-time randomization can adjust its algorithm to ensure the blocks integrity reducing the need for additional patients to be enrolled, 3) if a treatment arm is eliminated mid study, it quickly adjusts the remaining treatments by removing the arm from the settings.
Ad-hoc reports are available to users any time. They are easy to customize and share. Whatever custom information is not part of a standard summary can quickly be turned into an ad-hoc report. Reports can be printed, exported and shared. Existing reports are always up to date with the latest information; no need to run a report – just access it. Many of our clients indicate they love the reporting function because they no longer have to export into excel and send weekly reports. Instead, once the report is shared, anyone can access it anytime.
Graphing and Statistics allow users to quickly view information visually or in a table so they can keep track of what is happening in their study. Using the basic statistical analysis, unmasked users can quickly determine the efficacy of a treatment arm. If a treatment arm appears ineffective, it can quickly be eliminated saving both time and money. Like reports, graphs and statistical reports can be shared and are always up to date.
Inventory management and automatic reordering streamlines the process of managing inventory reducing the time it takes dramatically. As inventory is dispensed to a patient, the system automatically reconciles the available inventory. Once the pre-set low inventory threshold is reached, CTOP’s VISION automatically orders additional inventory and notifies both the site and monitors that the order was placed. Once the order is received, the site and monitors are again notified. Imagine not having to worry about how much inventory a site has because CTOP automatically does that for you. How much time would be saved and how much less stressful would this make the monitor’s job?
Invoicing is a time consuming task for most studies. It is also a stressful part of the relationship with sites when payments are not made in a timely manner. It is not uncommon for both sites and monitors to spend a large percentage of their time just on invoicing. CTOP’s invoicing jut happens! During the normal site’s signing of the forms and monitor’s reviewing the forms, CTOP recognizes that the monitor has approved the forms which trigger a payment to post to the invoice automatically. Sure, the monitor can double check the fee has posted, but since the software is validated and tested before going live, the monitor can simply be confident the invoices being submitted are correct. Sure, occasional additional payments are necessary and there is a place to add those too. Never before has invoicing been so automatic and easy. Suddenly sites are getting paid regularly and monitor’s time is freed up for additional monitoring.
Document management standard summaries quickly allow user to view if a document has been uploaded or is missing. Users can quickly access the document for download and review within a couple of clicks. This allows monitors to be more efficient and to ensure the required data is collected.
Taking advantage of all the tools CTOP has to offer allows studies to operate more efficiently. Like other EDCs as the data is collected edit checks help clean the data and ensure all required data is collected. Yet its many tools allow monitoring to be streamlined, enabling risk based monitoring to occur quickly by using the metrics that could indicate poor site performance. It’s tools such as inventory management, invoicing and document management greatly reduce the time monitors spend tracking and managing these tasks so their time can be spent ensuring quality data and timely recruitment strategies are implemented. Reporting and analyzing mid study data is accelerated when they are shared and automatically updated when accessed. No more time is spent regularly updating reports; it happens automatically.
Providing our clients with the tools they need to operate their studies more efficiently and take their drugs and devices to market sooner drives Prelude Dynamics innovation and desire to provide the industry’s best Clinical Trail Optimization Platform. After all, these are live saving drugs and life changing devices and it is the way we can contribute to better human and animal health.