Full-scope support from trial design and startup through execution and closeout—tailored to your development stage and internal resources.
Oversight and delivery of trials across the U.S., EU, UK, APAC, and Latin America, with fluency in diverse regulatory requirements and local nuances.
Selection, negotiation, and management of CROs and service providers to ensure accountability, quality, and cost-effectiveness.
Development of fit-for-purpose SOPs, workflows, and operational frameworks that ensure GCP compliance and inspection readiness, without overburdening teams.
Implementing structured risk assessment frameworks to identify operational, regulatory, and strategic risks early—and developing pragmatic mitigation plans to keep programs on track and inspection-ready.
Driving alignment across clinical development, regulatory, medical affairs, and commercial to ensure cohesive execution and strategic decision-making.
Strategic evaluation of clinical-stage assets to inform investment, licensing, or acquisition decisions. Leveraging deep clinical, regulatory, and legal expertise to assess risk, value, compliance, and program readiness across the development lifecycle.
We’d love to hear about your upcoming milestones and explore how we can support your team.
