Clinical Development Consulting

Integrated Guidance to Help You Successfully Bring Your Product to Market

Clinical Development Consulting

Integrated Guidance to Help You Successfully Bring Your Product to Market

Our Expert Team Will Help You Create a Clinical Development Plan Fully in Line With Your Product While Ensuring Regulatory Compliance
  • Be ready for regulatory reviewer teams by gaining an integrated perspective.
  • Save on clinical trial costs and time by having the right combination of expertise advising your team.
  • Prepare for your post-marketing strategy by having access to an even broader range of experts in Real-World Solutions, Market Access, and Transaction Advisory.

Our Team Reflects the Structure of the Reviewer’s Team

Regulatory Strategy

Our Regulatory Experts get you ready for interactions with regulators (EU, US) across all stages of drug development, regulatory strategy & gap analysis, accelerated development (BTD, PRIME), CCDS, label design, IND/CTA, BLA/NDA/MAA.

Medical Strategy

Our Medical Strategists bring deep expertise to provide guidance every step of the way to ensure that your plan is ready for every contingency and opportunity.

Biostatistics

Our Biostatisticians contribute unmatched statistical expertise including CDISC, Estimand Strategy, Statistical Modelling and Biomarker Discovery Analysis, DMC Membership.

Clinical Operations

Our Clinical Experts take a cross-functional approach to meet Global regulatory requirements and complex endpoints through traditional and innovative study design.

Patient Engagement

Our Patient Engagement team partners with Patients along product development cycle thanks to Patient Advisory Boards, Patient Support Groups, and Patient Mobilization Programs for clinical trials.

Why Choose Us to Support Your Clinical Development Plan?

Mock negotiations and payer consultations
 

Contact Us to Learn More About How We Can Support Your Needs

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