Our Services

Agassiz provides senior consulting across the full span of clinical development- from early bioanalytical work through regulatory submission.

We work where the complexity is.

Core Consulting Areas

Clinical Research

Bioanalytical 

Data/Biostatistics

compliance

Program Management

Clinical Research

For innovator, biotech, and specialty pharma companies.

A clinical trial is only as strong as its foundation. At Agassiz CRP, our expertise provides our clients with independent assessments throughout the life of the clinical trial from protocol development/design to supporting regulatory inspections after the submission of your final reports.

    • Review clinical trial protocols for scientific soundness and regulatory‐compliance.

    • Review inclusion/exclusion criteria, dosing regimens, safety, and statistical plans for robustness.

    • Appraise site selection, qualification, and initiation activities.

    • Advise on regulatory submissions, ethics committee approvals, and site contract negotiations.

    • Assess site staff training program.

    • Evaluate data collection system(s).

  • Enhance the sponsor’s understanding of the risks associated with reported:

    • Patient enrollment, safety, and data collection.

    • GCP and protocol compliance.

    • Delays in query resolution.

    • Site performance metrics.

    • Advise database lock

    • Evaluate final monitoring visits, study material reconciliation.

    • Evaluate archiving essential documents.

    • Advise and review clinical study reports

    • Conduct ‘readiness’ audits/inspections.

    • Oversee logistics of sample collection, processing, shipment, and storage

    • Assess lab turnaround time and quality control procedures.

    • Evaluate harmonization of multi‑site lab practices and reporting standards.

    • Provide advice on method development and validations as per ICH/FDA/EMA regulatory guidance.

    • Assess bioanalytical accuracy, precision, sensitivity, selectivity, and stability parameters.

    • Review validation reports for completeness and compliance.

    • Assess compliance to SOPs and GLP/GCP standards for routine bio-sample processing and analysis.

    • Review data integrity, audit trails, and batch acceptance criteria.

    • Review analytical reports for completeness and compliance.

    • Appraise bioanalytical site selection, qualification, and initiation activities.

Bioanalytical

    • Assess Electronic Data Capture (EDC) systems are   configured to meet protocol requirements.

    • Provide advice on edit checks, query logic, and data validation rules.

    • Review statistical analysis plans for alignment with study objectives and anticipated regulatory expectations.

    • Review sample size and power calculations for robustness.

    • Assess endpoint statistical models.

    • Review statistical design for regulatory‑ready documentation.

    • Review pharmacokinetic (PK) and pharmacodynamic (PD) modeling targets.

    • Assess data integration for bioanalytical and clinical endpoints.

    • Advise on in-process decisionmaking and regulatory interactions based upon interim analyses.

    • Assessing statistical tables, listings, and figures for supporting study endpoints.

    • Review clinical, bioanalytical and statistical study reports to identify potential gaps and readiness for submission.

Data / Biostatistics

    • Review regulatory submissions for good science and alignment with regulatory expectations.

    • Assist in coordinating between scientific, clinical, and data teams to deliver high‑quality regulatory documents.

    • Support our clients’ teams preparing for regulatory meetings and correspondence.

    • Review briefing documents and client / study site responses for clarity, consistency and defensibility.

    • Review regulatory feedback and guide client team implementing  required responses and/or remediation.

    • Advise on adherence to Good Practices (GLP, GCP) across bioanalytical, clinical, and data workflows.

    • Review processes and documentation for compliance with regulatory guidelines and/or standards.

    • Conduct ‘mock regulatory audits’ to assist with inspection ‘readiness’.

    • Assist with responses and follow up to regulatory inspections.

Compliance

  • Provide independent support to sponsors to:

    • Enhance project timeline achievability within development milestones.

    • Extrapolate trial progress against critical path activities and proactively address timeline deviations.

    • Advise on risk identification, mitigation strategies, and contingency planning.

    • Review budgets for clear definition and alignment with project scope.

    • Advise on vendor selection, contracting, and performance.

    • Assist the sponsor in understanding the risks associated with CRO identified vendors.

    • Advise on project deliverables meeting internal standards and regulatory expectations.

    • Provide advice on quality processes across bioanalytical, clinical, and data management functions.

    • Providing an independent third party assessment of communications between sponsor and vendors. Monitor

Program Management

Not sure which service fits your situation?

Tell us about your program and we will help you figure it out.

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