TrialScope: Clinical Trial Transparency Simplified

Mark 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.