Clinical Trial Transparency
Expert-Led Transparency for the Life Sciences
Instem’s Clinical Trial Transparency (CTT) services help life science companies future-proof their data and document sharing processes through two core offerings: De-Identification Services and Transparency Strategy.
These offerings help companies reduce data security risks that could jeopardize patient privacy and sponsor confidentiality by delivering de-identification software tools, strategic guidance, and targeted education and training to ensure ongoing compliance.
What is Clinical Trial Transparency?
Instem provides Clinical Trial Transparency services through De-Identification Services and Transparency Strategy offerings.
De-Identification Services:
De-Identification Services offer an outsourced document and data sharing solution for the life sciences sector. We utilize our dedicated Blur™ anonymization software to provide rapid and comprehensive de-identification and re-identification risk assessments. This service helps companies of all sizes stay compliant in the face of challenges such as conflicting regulations, non-compliant legacy data, and the complexity of navigating numerous global registries.
Transparency Strategy:
Instem and its partners provide a Transparency Strategy service that combines strategic consulting with education and training to future-proof compliance challenges. Designed to address the inherent risks of sharing sensitive data, this service helps clients navigate complex and evolving regulations, meet data privacy requirements in Canada and the EU, and implement effective data de-identification practices.
Key Benefits of Clinical Trial Transparency Strategy
Increased Efficiency
The training provided through Clinical Trial Transparency services helps companies build strong internal processes, such as SOPs and playbooks, that streamline document preparation and data de-identification workflows.
Builds Resilience
These services build internal expertise, empowering teams to tackle future challenges with more confidence and clarity. This reduces reliance on external support and strengthens long-term operational stability.
Saves Time
Outsourcing de-identification through Instem’s De-Identification Services allows teams to meet tight deadlines faster by offloading complex, resource-intensive tasks to experienced specialists.
Improved Compliance
Clinical Trial Transparency services help companies achieve regulatory compliance on de-identification more quickly, allowing them to move through approval processes faster and with reduced risk of setbacks due to noncompliance.
Reduces Risk
Quantifiable risk assessments ensure data is properly anonymized, minimizing re-identification threats and helping organizations consistently meet global privacy standards.
Core Features
Clinical Trial Transparency services are delivered through two core offerings, each designed to address specific challenges and provide unique benefits for teams managing data security in clinical trials.
Data De-Identification
Comprehensive data de-identification services, fully outsourced or in a hybrid model, based on your team’s capacity and project scope. Ensures compliant, efficient de-identification tailored to your regulatory and operational needs.
Risk Assessment
Strategic Consulting
SOP and Playbook Development
Education
Training
Why Choose Clinical Trial Transparency?
Customer Success Story
The company chose Instem and its de-identification offerings for an initial three-year engagement. They leveraged Instem’s regulatory and data sharing expertise to shape their internal processes and gained valuable insights from regular governance meetings on emerging best practices.
The Results:
The client successfully prepared a compliant Health Canada Public Release of Clinical Information (HC PRCI) package for submission to Vivli. Through Instem’s Clinical Trial Transparency services, the client developed a standardized playbook and in-house expertise for handling future transparency requirements.
By implementing BioRails, Charles River optimized operations, enhanced compliance, and improved service delivery.
Director, Clinical Transparency and Trial Disclosure
How It Works
Assessment
Strategy Building
De-identification
Review
Deliver
Build Internal Capability
Generate internal expertise through collaborative approaches, education, and training on best practices for anonymization.
Frequently Asked Questions
Instem’s Clinical Trial Transparency services help organizations address key challenges while modernizing and future-proofing their de-identification and regulatory compliance approach. Below are some of the most frequently asked questions about this comprehensive suite of services.
Is the service fully outsourced, or can we manage parts internally?
Can we reuse the de-identification methods or strategy for future submissions?
How is re-identification risk assessed?
Do you provide redaction as well as anonymization?
Get a Free Demo Today
Clinical Trial Transparency provides clients with maximum flexibility and reliability to eliminate risks associated with clinical data submission and transfer. Trusted by leading pharmaceutical companies, this service allows organizations to leverage expert support while gradually developing their own in-house capabilities.
Speak to our experts for De-Identification Services and Transparency Strategy today.