CLINICAL TRIAL DESIGN
STUDY DESIGN & PROTOCOL DEVELOPMENT FOR CLINICAL TRIALS
Accudata Solutions has over 25 years of experience helping pharmaceutical, medical device, diagnostic, and biotech companies design better studies with a unique combination of intentional, jargon-free communication with all clinical team members and cutting-edge statistical methodology.
Sample Size Estimation
Selection of endpoints including multiple primary endpoints, hierarchical endpoints, composite endpoints
Advanced study design, e.g. group sequential, adaptive
Negotiation with IRBs and regulatory bodies
Regulatory pathways: 510(k), De Novo, LDT, PMA, NDA, BLA