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Phase I Services

Biomedical Consulting International, Inc has extensive experience in the development of product development strategies to enable new chemical/biological entities and/or new dosage forms of existing entities and/or new/improved medical devices to enter Phase I clinical trials as expeditiously as possible. This preparation typically starts 6 to 12 months prior to the intended filing date of the IND, CTA or IDE depending upon the specifics of the development stage product. BCI Phase I Clinical Services may take many forms:

  • From strategic oversight;
  • To partnering with the client to develop the clinical trial design and the rest of the IND, CTA or IDE package; this may also include the preparation For and attendance at meetings with regulatory authorities (pre-IND, pre-IDE or scientific advise) associated with the Phase I program;
  • To BCI performing all services required on behalf of the client to enable the entry into Phase I.