Clinical Development and Study Design

QST’s clinical staff have years of experience in creating personalized, quality clinical studies for a variety of clients. QST has consulted on more than 800 clinical trials and 75 non-clinical trials, giving us the knowledge and expertise to craft the perfect solution for any study.

After developing, researching, and selecting the appropriate statistical methodology for the clinical trial, QST uses the following steps to create the optimal study for your needs
  1. Protocol Development
  2. Design and preparation of IDE, NDA, ANDA, PMA, and 510(k) FDA submissions
  3. Advising on study design including appropriate endpoints
  4. Performing sample size computations, power computations, and power analyses
  5. Designing statistical methods for analysis
  6. Participation on Data Safety Monitoring Boards
Types of Studies
  • Pre-Clinical
  • Toxicity Studies
  • Pharmacokinetic and pharmacodynamic studies
  • Phase I-IV studies
  • Long-Term Safety Studies
  • Post-marketing studies