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Why AGADA?
We bring dedicated expertise to programs with little room for error, providing scientific support, responsiveness and program fit to help rare disease teams move forward with clarity.
Credibility & expertise
We apply focused expertise where it matters most, supporting critical stages of development with rare disease realities in mind and connecting patient needs, rigorous methods and regulatory expectations.
That means we can step in where specialist input is needed, helping to shape the right path forward for your program and bring confidence to the decisions that follow.
Decade of specialization:
Founded in 2013 as a spinout from Children’s National Medical Center to provide specialist scientific support for rare disease drug development.
Dedicated scale:
We operate with a team of approximately 50 employees, entirely focused on executing complex rare disease programs.
Consistent audit success:
We successfully pass an average of five sponsor audits annually to support clinical trials across multiple phases.
Historical benchmarking:
We leverage archival data from over 100 trials in mouse models of muscular dystrophy to accurately power your efficacy studies.
Where we help
We contribute where focused support can make the greatest difference. That may be at a specific stage of development, within a defined workflow or around a capability that needs specialist input.
Clinical specimen management
We provide real-time procedural oversight and precision handling for frozen muscle tissue to protect longitudinal data integrity across your global clinical trial sites.
Bioanalytical method validation
We supply pre-validated bioassays and fit-for-purpose method development to accurately measure critical biomarkers and satisfy stringent FDA expectations for primary outcomes.
Preclinical services
We execute rigorous in vitro and in vivo efficacy studies utilizing deep historical data across established rare disease models to ensure accurate statistical powering.
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.
Get in touch?
To learn how AGADA Biosciences could support your program, get in touch with our team and start the conversation.
How we work
We bring an agile, collaborative and responsive approach to every engagement, shaping our support around the needs of your program rather than a rigid process. Whether you engage us at a single stage or across multiple points in development, we work to de-risk programs, protect data integrity and help your teams keep programs moving forward.
1.
Refined for your program:
We shape our approach around the needs of each program, not the other way around.
2.
Direct access to senior experts:
Our lean model keeps scientific expertise close to the work and communication clear.
3.
Built to de-risk progress:
We help you de-risk development through rigorous science and practical support.
4.
Protecting data integrity:
Our work is designed to support reliable outputs and maintain trust in the data.
Who we work with
Whether you work in translational science, bioanalytical and biomarker development, preclinical, clinical operations or outsourcing, you need support you can trust. At AGADA Biosciences, we bring dedicated expertise and support shaped around your program to help de-risk development and protect data integrity at every stage.
We support sponsors across Canada, the United States, the United Kingdom, Europe and Asia. Operating from our state-of-the-art facility in Halifax, approximately 70% of our clinical programs are US-based. Our bidirectional shipping and active temperature monitoring enable us to oversee cross-border logistics and help secure the chain of custody for your program.
Quality & 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 for both scientific and outsourcing audiences.
Meet our leadership team
