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.