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.

submit send
submit send

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

R

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.

R

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.

R

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.

R

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.

R

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.

send deliver

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.

send comply

Risk Assessment

Quantifies re-identification risk using a structured, validated methodology. Provides an auditable system to support regulatory compliance and defensible decision-making.
send advise

Strategic Consulting

Advises on evolving regulatory demand patterns and vendor strategies and applies risk-based frameworks to support compliant disclosure planning.
send source

SOP and Playbook Development

Develops customized SOPs and operational playbooks to guide consistent, defensible decision-making for future transparency and disclosure scenarios.
send warehouse

Education

Delivers focused training on EMA Policy 0070, Health Canada PRCI, and research data sharing, building team confidence in meeting global transparency requirements.
send warehouse

Training

Trains teams to balance internal privacy concerns with external disclosure requirements. Includes simulated disclosure events to prepare for real-world transparency scenarios.

Why Choose Clinical Trial Transparency?

Instem equips organizations with the expertise and tools needed to navigate the complexities of modern clinical research. Sharing data presents various hurdles, including strict compliance requirements, limited in-house expertise, tight deadlines, and insufficient tools or resources.
Instem’s Clinical Trial Transparency services offer organizations immediate support for specific de-identification tasks and long-term strategies to build future-ready resilience. With a proven track record, Instem has successfully supported over 40 EMA Policy 0070 submissions and more than 30 Health Canada submissions for some of the most prominent pharma organizations, including Pfizer, Merck, and AstraZeneca. Our services are scalable to support organizations of all sizes, helping them achieve compliance through outsourced solutions, software-based tools, or a combination of both.

Customer Success Story

A top 10 pharmaceutical company sought a fully outsourced solution to develop its de-identification practices. They aimed to gradually integrate this technology into their internal workflows and ultimately make it a standard part of their processes.

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.

provantis
“You have made this a wonderful experience and we are really looking forward to starting more transparency projects with you”.

Director, Clinical Transparency and Trial Disclosure

How It Works

Instem’s Clinical Trial Transparency (CTT) services optimize and streamline your CTT projects with an advanced set of expert-led services to ensure compliance and efficiency.

Assessment

Instem experts provide a tailored consultation to define your project scope, regulatory needs, and resourcing model.

Strategy Building

We develop a custom transparency strategy, including SOPs and governance models, aligned with global disclosure requirements.

De-identification

Data is de-identified in-house with quantifiable risk assessments to ensure compliance.

Review

Perform anonymization QC and run simulated disclosure events to validate strategies and prepare your team for real-world scenarios.

Deliver

Send submission-ready, fully compliant packages.

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?

The service is flexible. You can opt for a fully outsourced model or retain control over specific tasks through a hybrid approach, depending on your team’s capacity and goals.

Can we reuse the de-identification methods or strategy for future submissions?

Yes, we help you develop SOPs and a playbook so your internal team can apply consistent, compliant practices across future projects.

How is re-identification risk assessed?

Risk is quantified using a validated, auditable framework that meets global regulatory standards, ensuring defensible decision-making.

Do you provide redaction as well as anonymization?

Yes, we support both redaction and anonymization workflows, depending on regulatory guidance and the nature of the data being disclosed.

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.