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Quality assessment and reporting
Defending data integrity through rigorous procedural control and strict compliance with global regulations
Proactive quality control for frozen tissue
We treat biopsy handling as a rigorous scientific method. Our team provides strict procedural control to identify freezing artifacts and inconsistencies before they propagate into downstream analysis, protecting your limited patient tissue.
Regulatory-compliant outputs
Our senior scientists structure every quality report to match the specific context of use for your program, ensuring your data is strictly fit for purpose and ready for agency review.
Real-time oversight
We observe tissue processing procedures live to correct freezing and packaging techniques in the moment.
Bidirectional logistics
We maintain a strict chain of custody across international borders using specific shippers and continuous temperature monitoring.
Audit readiness
We design our standard operating procedures to withstand stringent agency scrutiny and support accelerated approval pathways.
Discuss your reporting requirements
Engage our specialists to establish a secure chain of custody and rigorous procedural oversight for your frozen muscle biopsies.
Audit-ready processes for complex global trials
Our team operates with deep familiarity across FDA and EMA regulations to ensure your data remains interpretable worldwide. We maintain a strong track record of successful sponsor audits across multiple clinical phases.
Consistent audit success:
We successfully pass an average of five sponsor audits annually to support clinical trials at different phases.
FDA approval history:
Our quality assessments directly supported a successful FDA audit, leading to approval of a rare disease drug.
Global regulatory alignment:
We operate in strict compliance with GCP, GLP and GDPR regulations to ensure your data is defensible across international markets.
Mandatory certification:
Every AGADA team member must obtain CITI certification in GCP, GLP and GDPR before supporting any sponsor trial.
Flexible protocol integration
AGADA Biosciences acts as a collaborative partner built to integrate directly into your existing vendor ecosystem. We can rapidly apply your existing protocols or generate specific instructions tailored to other vendors to ensure smooth sample exchange.
Direct access to senior scientific oversight
You work directly with the senior scientists overseeing your procedures to ensure methods remain fit for purpose and aligned with your ultimate clinical goals.
Targeted sample allocation:
We process frozen sections specifically for each vendor to prevent the waste of limited patient tissue and maintain rigorous control.
Continuous monitoring:
We use temperature tags and dry-ice top-ups to track real-time temperature fluctuations for every cross-border shipment.
Context of use alignment:
We help define the exact context of use early in development so your endpoints clearly reflect true disease biology.
Smooth integration:
We manage specialized workflows without requiring full control of your trial.
Start a conversation
Reach out to our team to ensure your clinical data is protected and ready for submission.
Where history meets innovation
In the heart of downtown Halifax, AGADA has transformed a historic building into a modern facility dedicated to advancing rare disease therapeutics. Take a closer look at our laboratories, scientific capabilities and dedicated team and discover how our unique location and collaborative environment support the work we do for clients and patients worldwide.
Quality and compliance
Quality and compliance are central to how we work. From rigorous processes to audit readiness and clear standards, this is a key part of how we build confidence and support informed decision-making.
Meet our leadership team
Our founders and senior scientists are globally recognized leaders in rare and neuromuscular disease research, bringing decades of specialized expertise to your program.
Related resources
We proactively identify freezing artifacts and procedural inconsistencies to protect the integrity of frozen muscle biopsies across global clinical sites.
