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.
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