TrialScope Clinical Trial Compliance and Transparency Systems
TrialScope simplifies the complexities of clinical transparency management. Its proven solutions have been implemented successfully and thoroughly tested in the most complex environments with solutions that are currently implemented at 12 of the top 30 global clinical trial sponsors, including six from the top ten.
The company’s tools, systems and expertise enable sponsors to improve their clinical trial processes, mitigate registry and lifecycle risk, and ultimately achieve greater compliance. TrialScope technology offers a fully validated SaaS platform hosted in a private cloud.
Content management platform for clinical trial disclosure and reporting results
TrailScope’s flagship product, PharmaCM, is a content management platform designed to help sponsors track and manage complex clinical trial disclosure and results reporting processes. The PharmaCM platform enables integration with disparate internal data sources such as CTMS and CDM systems. The PharmaCM platform is the foundation for the modules that support clinical transparency, data transparency and sponsor trial site development.
Editing, reviewing, submission and maintenance of clinical trial disclosure information
PharmaCM manages the complex process of editing, review, approval, submission and ongoing maintenance of clinical trial disclosure information. The system helps sponsors meet their compliance commitments by simplifying and controlling the information flow into ClinicalTrials.gov and other international registries such as EudraCT.
Managing clinical trial data
PharmaCM helps sponsors manage clinical trial data requests, communicate with parties involved and provide access to data once the request has been approved. PharmaCM workflows ensure that appropriate personnel are notified of a data request, that the request is processed according to the sponsor’s documented procedures, and that communication about the outcome of the request is tracked and managed.
Developing sponsor-specific clinical trial websites
PharmaCM is a platform for clinical trial sponsors to use as a framework to develop a sponsor-specific website for their clinical trial information. All information presented on the website is fed directly from PharmaCM following a full edit / review / approval process by the clinical trial sponsor. This ensures timely updates and accuracy of clinical trial information: disclosure and results reporting.
Providing clinical trial sponsors with transparency and compliance
Since the first US Federal law was passed in 1997 (FDAMA) requiring NIH to create a public information resource for certain clinical trials regulated by the FDA, registration and results reporting has become much more complex, with additional compliance reporting timelines and data requirements being implemented.
Adding complexity, sponsors must also track and manage updates to the submitted information as a trial is completed. This creates a very dynamic information management challenge that traditionally requires significant effort, time and resources to track and manage. Today, there are also additional international registries with different information and compliance requirements.
Since its introduction in February 2000, more than 172,000 trials have been registered on ClinicalTrials.gov alone. This number gives a small indication of the breadth of the clinical trial disclosure and results reporting challenge that sponsors must manage on a daily basis.
PharmaCM helps sponsors:
- Ensure compliance with ClinicalTrials.gov, EudraCT and other clinical trial registry timelines
- Improve data quality by reducing manual and error-prone data handling
- Reduce the resource burden and decrease maintenance cycles by automating and simplifying information management
- Minimize IT support and corresponding IT footprint
- Access and understand global compliance status
Introduction to Clinical Trial Disclosure: History, Trends and Best Practices
Clinical Trial Disclosure is a compliance requirement that faces life sciences organisations worldwide.
Improving Compliance While Reducing Resources
A global sponsor organisation that develops pharmaceuticals, biologics, medical devices and over-the-counter products, sought a better approach to clinical trial registration and results disclosure requirements in the US.
Case Study: One Source Drives One Process for Clinical Trial Transparency
A global top ten clinical trial sponsor was challenged by lengthy, resource intensive processes to support compliance in clinical trial registration and results reporting.
TrialScope has been recognised by CIOReview as one of 2016's 20 Most Promising Pharma and Life Sciences Tech Solution Providers.Read more
TrialScope has recently conducted its Clinical Trial Transparency Leadership Forum, as part of its Transparency Leadership series.Read more
TrialScope will be in Philadelphia for the CBI Prep Forum for the New EU Clinical Trial Regulation.Read more
TrialScope has announced the release of Convert, a free online clinical trial data conversion service.Read more
Bridge Capital Holdings, whose subsidiary is Bridge Bank, announced it has provided TrialScope with a $2 million revolving credit facility based on monthly recurring revenue.Read more
TrialScope has announced general availability of the latest release of the PharmaCM platform v.2.2.Read more
TrialScope announced it has appointed Richard Aguinaldo as chief financial officer (CFO).Read more
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