Late Phase Study Design

The principles and employees of REGISTRAT-MAPI bring years of multidisciplinary expertise working specifically with the complexities and nuances of Late Phase studies. By uniting strategic, clinical, biostatistical, and project and data management expertise, we have developed a strong team that provides a complete spectrum of integrated services required for conducting valuable global Late Phase research.

Additionally, REGISTRAT-MAPI assists companies to perform pre-market assessment and evaluation of potential risks associated with a product to determine the benefit/risk balance associated with a product and measures that will be put into place to minimize the risk of adverse medical consequences. In the U.S., post-marketing requirement studies and REMS are increasingly being mandated as a condition of approval for new products with potential safety issues.

At REGISTRAT-MAPI we focus specifically on the design and conduct of Late Phase studies which includes a variety of research designs.

  • Phase IIIb Study
  • Phase IV Study
  • Prospective Study
  • Retrospective Study
  • Disease Registry
  • Product Registry
  • Pregnancy Exposure Registry
  • Case-control Study
  • Case Crossover Study
  • Qualitative Research
  • Quantitative Research