The Informa Clinical Data Disclosure event in Philadelphia this year brought numerous conversations on Company Confidential Information (CCI) to the forefront. For biopharmaceutical companies, protecting proprietary information and trade secrets is essential to safeguard valuable innovations and commercial interests. However, identifying which specific pieces of information constitute CCI within dense, technical documents like clinical study reports can be a complex undertaking.

CCI refers to any confidential information that relates to a clinical trial sponsor’s products, services, processes, research activities, or business operations, where the disclosure of which could potentially cause competitive harm.

In a clinical context, examples of CCI may include:

  • Proprietary bioanalytical methods or novel biomarkers
  • Unique statistical models or data analysis plans
  • Confidential formulation details or manufacturing processes
  • Strategic product development plans or regulatory filing strategies
  • Interim or unblinded efficacy data that could undermine study integrity

The transient nature of CCI

What makes CCI identification so nuanced and challenging is that the context in which information appears is critical to determining if it is truly confidential, hence the in-depth conversations at Informa’s Clinical Data Disclosure event. Certain technical details may be considered CCI in one scenario but not confidential in another context or time period.

Additionally, information that was initially CCI may become public knowledge over time as products are approved and information is disclosed based on current evolving transparency requirements in the pharmaceutical industry.

Conversely, information that was not originally considered CCI could potentially become confidential as a company’s product pipeline and research and development (R&D) strategies shift.

This transient, context-driven nature of CCI means that redaction or anonymization decisions require continual reassessment throughout a product’s life cycle rather than a one-size-fits-all approach.

The role of third-party vendors

To ensure the comprehensive and thoughtful identification of CCI, many pharmaceutical sponsors rely on knowledge and support from third-party vendors who specialize in document redaction, data anonymization, and information protection services.

These vendors, like TrialAssure, apply tailored, risk-based methodologies and assemble cross-functional teams comprised of scientific experts, regulatory professionals, intellectual property advisors, and other experts who can lend relevant subject matter and strategic advice.

By developing a deep understanding of each sponsor’s specific product portfolio, therapeutic area, development pipeline, data sharing commitments, and proprietary interests, vendors can provide customized CCI evaluations that balance transparency and confidentiality obligations.

Vendors should also have robust processes for monitoring changes in the external landscape and internal sponsor priorities that could influence what information needs to be classified as CCI over time.

Striking the Right Balance

Given the high stakes surrounding a company’s valuable intellectual property, it is critical that CCI assessments are rigorous, contextualized, and adaptable. Vendors, like TrialAssure, can play an invaluable role in supporting sponsors with these nuanced CCI decisions throughout a product’s life cycle.

By taking a holistic, cross-functional approach, vendors strive to strike the right balance between enabling responsible data sharing and transparency while still providing appropriate safeguards for legitimate trade secrets. This equilibrium is essential for biopharmaceutical companies to cultivate innovation, advance clinical science and ultimately bring new therapies to patients in need.

Read more on CCI Insights in a recent interview here.