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

Clinical Operations

Bioanalytical 

Data Management

Project Management

compliance

Statistics +
Biostatistics

Clinical Trials: Phase I - III

For innovator, biotech, and specialty pharma companies.

A clinical trial is only as strong as its foundation. We review protocols for scientific rigor and regulatory alignment before problems reach the site level.

    • Assure clinical trial protocols are scientifically sound and regulatory‐compliant.

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

    • Oversee 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).

    • Provide ‘readiness’ mock audits.

    • Provide oversight of patient enrollment, safety, and data collection.

    • Monitor GCP adherence, protocol compliance.

    • Monitor/assist with timely query resolution.

    • Review source data verification, adverse event reporting, and site performance metrics.

    • Safety - pharmacovigilance review

    • Oversee database lock

    • Conduct final monitoring visits, study material reconciliation.

    • Review archiving essential documents.

    • Advise and review clinical study reports

    • Conduct ‘readiness’ audits/inspections.

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

    • Monitor lab turnaround time and quality control procedures.

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

    • Advise method development and validations as per ICH/FDA/EMA regulatory guidance.

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

    • Review validation reports for completeness and compliance.

    • Oversee routine bio-sample processing and analysis.

    • Monitor adherence to SOPs and GLP/GCP standards.

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

    • Review analytical reports for completeness and compliance.

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

Bioanalytical Services

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

    • Oversee edit checks, query logic, and data validation rules.

    • Review data output for accuracy, completeness, and compliance.

    • 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.

    • Monitor data integration for bioanalytical and clinical endpoints.

    • Oversee interim analyses for in-process decision‑making and regulatory interactions.

    • Review statistical tables, listings, and figures for integrity and quality standards.

    • Review clinical, bioanalytical and statistical study reports to confirm 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 in-house 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

    • Review project timelines for achievability and alignment with development milestones.

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

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

    • Assure budgets are well‑defined, tracked, and aligned with project scope.

    • Assist with vendor selection, contracting, and performance monitoring.

    • Review vendor deliverables for compliance and quality.

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

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

    • Monitor communication channels to maintain transparency, efficiency, and stakeholder alignment.

Program Management

Not sure which service fits your situation?

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