TrialScope: Clinical Trial Transparency Simplified

TrialScope

Mark Heinold, CEO, TrialScopeMark Heinold, CEO
The process of disclosing clinical trial data can be quite arduous because many trial sponsors use spreadsheets and databases to track and manage clinical trial disclosure content. Mark Heinold, the CEO of TrialScope and his team of experts, are working to simplify the entire clinical trial transparency and data sharing process to make it easier for sponsors to manage compliance and disclosure content.

TrialScope’s SaaS-based solutions address many high-risk business challenges associated with non-compliance and inefficient data sharing practices. In fact, 16 of the top 30 clinical trial sponsors use TrialScope’s solutions to manage their transparency and data sharing processes.

TrialScope’s disclosure platform, PharmaCM, supports the complex process of authoring, editing, reviewing, approving, and ultimately publishing clinical trial disclosure data to global registries as well as sponsor-branded websites. The platform uses workflows, alerts, and notifications to facilitate content finalization. It also facilitates upload of this approved content to clinicaltrials.gov and EudraCT, two of the most widely recognized registries.

Additionally, the company introduced two new products earlier this year that are changing the way clinical trial sponsors approach their transparency initiatives. The Trial Results Summaries Portal enables sponsors to communicate more effectively with trial participants, researchers, and other interested parties by making trial results summaries (also known as lay language summaries) immediately available via the internet. This product has disrupted traditional paper-based distribution processes that are time consuming, and not tracked very well.


We maintain our leadership position not only because of our innovative technologies but also because our own disclosure experts drive our development efforts


The Trial Results Summaries Portal enables trial participants to subscribe to a specific trial and receive notifications about the availability of the trial results summary. This approach allows trial participants to have greater control over relevant health information and have immediate and ongoing access to the summaries anywhere there is an internet connection. The Trial Results Summaries Portal recognizes the great contribution that trial participants make to the clinical research process by improving patient communications.

The TrialScope team continues to produce novel solutions. They also launched Atlas Global Compliance this year. Atlas Global Compliance is a SaaS-based solution that enables sponsors to disclose locally and comply globally. The tool enables teams to get a snapshot of their global disclosure performance and to see which compliance deadlines may be in jeopardy. Traditionally, this type of information was stored in regional spreadsheets and desktop tracking tools, making it inaccessible to some team members and making a global view of disclosure performance impossible to obtain. Atlas democratizes access to this valuable information so that teams can increase compliance, proactively troubleshoot potential issues, and improve performance. Atlas contains a library of global rules that sponsors can immediately leverage as they expand clinical trials into new regions. This saves significant time and research costs but also helps to institutionalize the knowledge of local requirements.

With the launch of two new products earlier in the year, TrialScope looks to expand its portfolio as well as its target market. As a company focused on constantly innovating technology, TrialScope continues to collaborate with its customers to understand their most pressing business challenges and to provide solutions that meet their transparency, data sharing, and compliance needs. “We maintain our leadership position not only because of our innovative technologies but also because our own disclosure experts drive our development efforts.” The company’s efforts to understand and assess the various complexities of global compliance and the benefits of transparency to sponsors, patients, researchers, and other stakeholders in the marketplace sets them apart from its competitors. TrialScope’s ability to adapt, adopt, and adhere to the ever-changing global requirements makes it a top contender in the Life Sciences sector.

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TrialScope News

TrialScope Welcomes Moderna into Community of Clinical Trial Sponsors

Jeff Kozloff, CEO

Jersey City, NJ - TrialScope, the global leader in clinical trial disclosure and transparency management technology, is proud to announce the addition of Moderna to its growing customer roster.

TrialScope customers include 16 of the top 20 industry sponsors, who rely on its technology for trial disclosure management, patient engagement and study recruitment. Collectively, TrialScope customers are responsible for more than 40 percent of all industry trials on ClinicalTrials.gov and the EU-CTR.

Moderna has selected the TrialScope DiscloseTM platform to manage and automate its clinical trial disclosure process, maintain regulatory compliance and enhance its transparency efforts. In addition, with its trial information securely housed in the TrialScope Transparency CloudTM, Moderna will benefit from a single source that promotes consistency of data and facilitates repurposing data for increased efficiencies.

To complement use of the TrialScope Disclose platform, Moderna will avail itself of clinical trial disclosure services offered by TrialScope. These services “ including protocol registration, results disclosure, plain-language summaries and redaction of potentially confidential information “ are designed to help ease the workload of disclosure teams at organizations of all sizes.

This partnership comes at a crucial time for Moderna, which is a top contender for a COVID-19 vaccine. The federal government is supporting Modernas vaccine project with nearly $500 million and has chosen it as one of the first to enter large-scale human trials.

Moderna is committed to clinical trial disclosure and transparency, said Lakshmi Ramkumar, Head of Medical Writing. Partnering with industry-leader TrialScope enables us track, fulfill and report on global commitments via one end-to-end platform.

We are excited to share our technology and our expertise with Moderna, said TrialScope CEO Jeff Kozloff. While the coronavirus pandemic has proved a monumental challenge for people across the globe, Moderna is at the forefront of the fight, and we are thrilled to play a small but important supporting role.

For more information on TrialScope or TrialScope Disclose, visit TrialScope.com.



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