Home / Bioanalytical and biomarker services
Bioanalytical and biomarker services
De-risking rare disease programs with specialist CRO services from early planning through clinical execution.
Scientific rigor and SOP-driven processes
Our team applies decades of rare disease research and deep regulatory expertise to deliver CRO services that ensure your bioassays are strictly fit for purpose. We rely on established, SOP-driven workflows to generate defensible data that meets agency reviewers’ requirements and keeps your program on schedule.
Pre-validated bioassays:
Off-the-shelf assays for Duchenne, Becker and ALS save sponsors two to four months of validation time.
Unmatched biopsy success:
We maintain a near-100 % success rate with frozen-muscle biopsies to protect critical longitudinal patient data.
Real-time oversight:
We provide live procedural support for clinical sites globally to remove guesswork and ensure samples remain interpretable.
Regulatory readiness:
Our FDA-compliant bioassays are designed to withstand regulatory scrutiny and support accelerated approval pathways.
Our specialized capabilities
Clinical specimen management
We implement strict procedural controls for biopsy handling to protect your longitudinal patient data. Our team manages collection kits going out and frozen tissue coming back to maintain a secure chain of custody across global sites.
Bioanalytical method validation
We provide pre-validated, regulatory-compliant bioassays that dramatically reduce your setup timelines. Our off-the-shelf methods for rare diseases save sponsors hundreds of thousands of dollars in internal validation costs.
Preclinical services
We execute robust efficacy studies utilizing deep expertise in rare disease models. Our harmonized workflows ensure preclinical data remains strictly fit-for-purpose and anticipates clinical requirements.
Translational Strategy Consulting
Successful rare disease programs begin with the right strategy. AGADA’s senior scientific team provides expert translational and regulatory guidance to help you define study objectives, select meaningful biomarker endpoints, and generate evidence that supports confident decision-making. By aligning your program with FDA and EMA expectations from the outset, we help reduce risk and accelerate development.
Built to integrate, not replace
AGADA Biosciences acts as a collaborative partner built to integrate directly into your existing vendor ecosystem. We manage specialized workflows like frozen tissue handling and precise bioassays without requiring full control of your trial. This model establishes clear accountability and smooth sample exchange, exactly where specialist input makes the greatest difference.
Bidirectional logistics:
We manage sample kits going out and frozen tissue coming back to maintain a strict chain of custody across borders.
Seamless sample exchange:
We bypass central laboratories for frozen tissue, ensuring samples are processed correctly the first time.
Context of use guidance:
We align preclinical endpoints with anticipated clinical readouts so that your data is fit-for-purpose.
Direct access:
Our lean model keeps scientific expertise close to the work, ensuring fast escalation paths and rapid issue resolution.
Need to get in touch?
Speak to our team today to find out more about the CRO services we offer and how we can de-risk your program.
