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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.

Clinical Data Analysis Biostatistics Research Pharmaceutical Medical Device Diagnostics Nonclinical

We provide:

  • 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

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