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?

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

→ Start a Conversation