We can support your in-house clinical trials with the following services we offer:

  • Study design  Selecting the primary and secondary hypotheses should always be done after modeling the expected and unexpected but fore-seeable data outcomes.
  • Contract database services: we can ensure an accurate and efficient database specification, assist in the outsourcing to commercial data "farms". and ensure appropriate procedures to control this relationship.
  • Establishing the reference clinical standards for adverse event assessment. Undertaking the review of un-anticiapted adverse events.
  • Generation of interim and final reports.

Our past experiences include the following:

  • Successful PMA IDE / 510k IDE.
  • Presentations to FDA Panel.
  • HIPAA compliant Quality Assurance Studies.
  • Multi-site postmarket Registries in both the USA and the EU.