Aegis Clinical Strategy is a specialist clinical development consultancy supporting biotech, pharmaceutical and CRO organisations from first-in-human studies through Phase 1–3 and across global clinical development programs.

We provide senior medical leadership and practical execution support across clinical development strategy, medical monitoring, safety oversight, protocol and study-design review, eligibility and medical data review, FIH/SAD/MAD and dose-escalation oversight, SRC/DSMB support, risk-based quality management, pharmacovigilance advisory and clinical-regulatory medical writing.

Our experience spans complex and innovative therapeutics, including cell and gene therapy, CAR-T, gene therapy, antibody-drug conjugates, radiopharmaceuticals, RNA therapeutics and precision or biomarker-led clinical development.

Therapeutic expertise includes oncology and haematology, immunology and inflammatory diseases, rare diseases, neurology and CNS disorders, gastroenterology and hepatology, respiratory disease, metabolic disorders, dermatology, vaccines and infectious diseases.

We also support regulatory strategy and submissions, health-authority interactions, development planning, briefing documents and responses to regulatory questions. Our quality and governance support includes SOP and QMS development, vendor and study oversight, quality-risk management, CAPA support, inspection and audit readiness, and fit-for-purpose clinical governance frameworks.

Based in Sydney, Aegis supports sponsors and CROs across Australia, Asia-Pacific, Europe and North America through project-based advisory, independent medical monitoring and fractional medical leadership. Our approach combines scientific depth, regulatory insight, robust safety oversight and pragmatic quality systems aligned with each asset’s development stage, risks and operational requirements.

Aegis Clinical Strategy

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Aegis Clinical Strategy

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