TrialScope Transparency Management

Source: TrialScope

Clinical trial sponsors are required by law to disclose information on their clinical trials in multiple places. These regulatory requirements continue to change as new mandated registries emerge and the scope of disclosure expands. This dynamic scenario creates a challenge for sponsors who must track and manage disclosure content that is being prepared for different registries, with different requirements.

PharmaCM CT enables sponsors to gain control of clinical trial disclosure processes by providing:

  • Management and tracking of disclosure content
  • Automated workflows that minimize risk and improve efficiencies
  • Alerts and notifications when a compliance deadline is looming
  • A centralized approach with “one authoritative source” for all clinical trial disclosure processes and content.

In order to demonstrate a deeper commitment to clinical trial transparency than the law requires, some sponsors are choosing to provide additional information about their portfolio of clinical trials on a dedicated website. This option does not tie them to a particular disclosure format or data requirement and provides them with full control over branding. It is important that this information aligns with any information that has or will be submitted to a public registry.

TrialScope created PharmaCM ST (Site Transparency) to help sponsors manage clinical trial content that is being prepared for disclosure on their own sites. PharmaCM ST is a framework for a clinical trial sponsor to use to develop a sponsor-specific website for their clinical trial information. It provides:

  • A controlled environment for the sponsor to use when preparing clinical trial information
  • Control over the presentation of clinical trial data by sponsor
  • Integration with PharmaCM CT workflows to edit, review, and approve study information for public disclosure

Patients, researchers and other organizations request clinical data associated with clinical trials including data sets, patient-level information, clinical study reports (CSRs), and trial protocols. The Requestors believe use of these data for additional research can help advance medical science, improve patient care, and benefit public health.

Clinical Trial Sponsors must manage and track these requests and the responses to ensure that accurate (approved) information is provided on a timely basis.

PharmaCM DT (Data Transparency) provides a seamless integration with PharmaCM CT, leveraging existing content authoring workflows and review and approval processes. It also centralizes and tracks all disclosure content in one location, simplifying compliance and reporting.

PharmaCM Study Synopsis automates document creation and enables clinical trial sponsors to reuse approved and disclosed data throughout the clinical content lifecycle. Data from PharmaCM is automatically downloaded to a word processing template, ensuring that copy and paste errors are eliminated. The document is then automatically routed for review and approvals, reducing staff coordination time in the process. The seamless integration with PharmaCM CT leverages your existing investment in disclosure content approval processes by enabling the use of approved clinical trial disclosure content for other clinical research documents.

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