Customizable Services
A La Carte Services
Our broad range of support options provide solutions that positively impact your development program. Contact us to discuss your current needs and we can recommend the services best suited for your situation.
Biostatistics
Utilizing cutting-edge biostatistics approaches and expertise to enhance clinical study design, data analysis, and interpretation.
Clinical Operations
Customizable clinical support services for global Phase I-IV studies from start up to close out.
DMC/DSMB Management
Full-service stewardship of Data Monitoring Committees/Data Safety Monitoring Boards and handling of all administrative tasks from initial formation and throughout the program’s lifecycle.
Global Pharmacovigilance and Signal Detection
Subject safety is our top priority! Our nuanced PV approached will be tailored to your clinical program to assure the cleanest possible safety profile and full regulatory compliance.
Health Economics and Outcomes Research
Early HEOR guidance will pay off to position your development program for optimal decision-making.
Medical Affairs
World class medical expertise to provide medical insight to your development program and medical/safety monitoring for your clinical trials.
Medical Writing
Full spectrum medical and regulatory writing services from pre-clinical reports through drug development and post-marketing documentation and labelling.
Nonclinical Services
Worldclass scientists and researchers to support your drug development program.
Regulatory Affairs
40 years of regulatory experience for drugs, devices, OTC, and medical foods to drive the regulatory framework for successful and more rapid approval.
Strategic Planning
A flexible development strategy stemming from a comprehensive understanding of the target market is needed successfully navigate drug development toward regulatory approval.