TrialScope Clinical Trial Compliance and Transparency Systems

trialscope

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

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Press Release

TrialScope in CIOReview’s 20 Most Promising Pharma Tech Providers

TrialScope has been recognised by CIOReview as one of 2016's 20 Most Promising Pharma and Life Sciences Tech Solution Providers.

Product and Services
White Papers

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.

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TrialScope

Harborside Financial Center

Plaza Five, Suite 2900

Jersey City

07311

New Jersey

United States of America

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Press Release

10 April 2016

TrialScope has been recognised by CIOReview as one of 2016's 20 Most Promising Pharma and Life Sciences Tech Solution Providers.

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17 December 2015

TrialScope has recently conducted its Clinical Trial Transparency Leadership Forum, as part of its Transparency Leadership series.

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13 October 2015

TrialScope will be in Philadelphia for the CBI Prep Forum for the New EU Clinical Trial Regulation.

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5 June 2015

TrialScope has announced it has relocated its headquarters to a larger space that accommodates the rapid growth the company has experienced and the expected growth in the next few years.

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8 April 2015

TrialScope has announced the release of Convert, a free online clinical trial data conversion service.

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29 March 2015

TrialScope has announced two executive appointments. Brian Flaherty will be vice-president of Business Development and Thomas Wicks has been appointed chief strategy officer (CSO).

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1 February 2015

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.

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8 December 2014

TrialScope has announced general availability of the latest release of the PharmaCM platform v.2.2.

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20 October 2014

TrialScope announced it has appointed Richard Aguinaldo as chief financial officer (CFO).

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Regional Offices

TrialScope, Inc

Harborside Plaza 10

Suite 400

Jersey City

07311

New Jersey

United States of America

+1 877 658 8310 www.TrialScopeinc.com
TrialScope

Harborside Financial Center

Plaza Five, Suite 2900

Jersey City

07311

New Jersey

United States of America

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