THE COUNTDOWN IS ON

Are your biospecimen management processes ready for ICH E6(R3)?

 
Days
 
Hours
 
Mins
 
Secs
until ICH E6(R3) is here
Ensure compliance before the EMA’s July 23rd 2025 deadline for global trials
ARE YOU READY?

Your path to ICH E6(R3) compliance

1

Assess your risk

Complete our free, self-guided risk assessment to determine where your biospecimen operations may be at risk for non-compliance
Critical
Take assessment
2

Consult with experts

Slope’s experts will audit your processes and review your risk assessment results against ICH E6(R3) requirements to determine your compliance risk
Schedule a meeting
3

Get recommendations

Receive a free custom risk report, with recommendations tailored to your organization, that you can leverage to ensure compliance
Download example
Educate your team Download our comprehensive ICH E6(R3) guide, browse our ICH E6(R3) blogs, and attend our webinar series.
Tools & resources
ASSESS YOUR RISK

Take our free, self-guided ICH E6(R3) risk assessment

This scorecard evaluates sponsor preparedness for updated biospecimen management requirements under ICH E6(R3), focusing on three critical compliance pillars.

Self-assess your org's operation to get your own non-compliance risk scorecard like this example
RISK ASSESSEMENT SCORECARD
1
Risk-Based Quality Management
Moderate
2
Data Governance & Integrity
Critical
3
Oversight & Accountability
Low
Get a scorecard

Already got your risk assessment scorecard? We're here to help.

‍Consult with our experts to discuss your results, and we'll produce an in-depth report with recommendations tailored to your org and trials.

Risk Assessment

For each question, please select the response that most closely aligns with your current biospecimen management processes as they relate to risk-based quality management, data governance, and sponsor oversight.

Risk-Based Quality Management
Sample Integrity Controls
How do you apply risk-based quality control mechanisms to enforce study-specific sample collection, processing, storage, and shipping parameters?
Controls for Sample Metadata Capture
How do you apply quality control mechanisms to enforce validated sample metadata capture for labs and eCRF?
Essential Record Documentation
Do you consider biospecimens to be a component of your essential records?
Sample Tracking & Monitoring
How does your organization track samples from collection to final destination?
Inventory Management
How do you manage lab kits and other supplies needed to support your biospecimen operations?
Data Governance & Integrity
Audit Trail Completeness
How quickly and easily can you retrieve any sample’s complete history?
System Validation Status
As the responsible party, have all of your computerised systems for biospecimen management been validated for use in your trial(s)?
Data Access Security
How do you govern access to spreadsheets used for sample tracking and other biospecimen-related trackers?
Oversight & Accountability
Fit-for-Purpose Assessment
What is your current process for ensuring that your biospecimen management tools are fit for purpose?
Role Documentation and Training
How robust is your training across stakeholders who support your biospecimen operations?
Stakeholder Collaboration
How are you supporting communication among stakeholders to ensure adherence to robust regulatory and scientific standards?
Lab Vendor Performance Monitoring
How frequently do you assess lab partners’ quality metrics?
Biospecimen Data Analytics/Metrics
What data analytics/metrics do you have access to in order to ensure quality across the entire biospecimen lifecycle?
Risk score calculated. Please see your risk scorecard below
Oops! Something went wrong while submitting the form.
Generate your risk scorecard
YOUR RISK ASSESSEMENT SCORECARD
1
Risk-Based Quality Management
2
Data Governance & Integrity
3
Oversight & Accountability
CONSULT WITH EXPERTS

Book your free ICH E6(R3) risk consultation today

Already got your risk assessment score? We're here to help.

Book a meeting with our experts to analyze your results and to dig deeper into your strategic approach to aligning your org's practices to the expectations of ICH E6(R3).

Following the consultation, we'll produce an in-depth Risk Assessment Report for Management Compliance with ICH E6(R3) including recommendations tailored to your org and trials.

Book consultation
Full example
RISK ASSESSEMENT REPORT
Leftward chevron icon.
Example PDF
?
Not seeing our calendar? Please use the button below to book your risk consultation
Book now
Some browsers seem to have trouble displaying our booking calendar
EDUCATE YOUR TEAM

Leverage ICH E6(R3) resources

Blog
Download our comprehensive ICH E6(R3) guide to dive deeper into the implications of the updated guidance.
Download guide
UNDERSTAND WHAT’S CHANGING

The way sponsors perform biospecimen management must evolve under ICH E6(R3).

Driven by the changing landscape of clinical trial tech solutions, ICH E6(R3) places greater emphasis on risk-based quality management, data governance, & sponsor accountability for study conduct.
ich E6(R2)
ich E6(R3)
Reactive vs. proactive approach to risk
→
Emphasis on proactive risk identification & mitigation across the biospecimen lifecycle
Fragmented, inconsistent data governance practices
→
Clear expectations for ensuring accuracy, traceability, & security for sample-related data using tech
Limited sponsor oversight of biospecimen stakeholders
→
Expanded sponsor accountability for oversight, risk, & quality
Biospecimen360™ is purpose-built

Slope drives compliance at every step of the biospecimen lifecycle

Slope’s Biospecimen360™ software ensures your biospecimen operations are ICH E6(R3) compliant. We provide the technology and expertise to mitigate risks, safeguard data integrity, and deliver real-time, comprehensive oversight across the biospecimen lifecycle.
Inventory Management
Guided Sample Collection, Processing, Storage, & Shipment
Streamlined, Standardized Sample Metadata Capture for Labs/EDC
End-to-End Traceable Chain of Custody, Supported by Integrations
Alerts & Data Insights for Real-Time Sample Tracking
Smarter data-driven resupply that automatically factors in expirations and on-site stock — plus intuitive research site tools for managing kits and supplies — minimize inventory-related deviations.
Lab-agnostic workflows with built-in guardrails and real-time alerts guide every step — collection, processing, storage, and shipment — preventing errors and giving sponsors instant sample visibility.
Eliminate the reliance on requisition forms or fragmented data through lab and EDC integrations. This automatic data sharing slashes lab queries, accelerates reconciliation, and gives sponsors instant, audit-ready visibility into every sample.
With biospecimens now a required part of the essential record, document sample collection and the complete sample audit trail in one centralized location.
Ensure proper oversight of sample management activities, enabling proactive intervention and informed decision-making for optimal quality across your biospecimen operations.
On-Demand Webinar

The Impact of ICH E6(R3) on Biospecimen Management

The transition from ICH E6(R2) to ICH E6(R3) marks a pivotal shift in regulatory expectations for biospecimen management in clinical research. With an expanded emphasis on risk-based quality management, enhanced data governance requirements, and increased sponsor oversight responsibilities, organizations must evolve their internal processes to maintain compliance.

Join us for an insightful webinar featuring distinguished experts, including Edye Edens, Rust Felix, and Aman Khera. Together, they will delve into how ICH E6(R3) will redefine biospecimen management practices. Don't miss this opportunity to prepare for the future of clinical research.

Watch now
Edye Edens
Life Sciences Legal & Regulatory Expert, Kulkarni Law Firm
Rust Felix
CEO & Co-founder, Slope
Aman Khera
Regulatory Science & Innovation Advisor; President, TOPRA
Are you ready?Assess your riskConsult with expertsEducate your team
Slope logo.
Get started today
See what you and your team have been missing
Request a demo