SERVICES&CASE

CASES

  • A US firm applied for a CTA for its global Sarcoma Trial. The original CRO failed to achieve the CTA approval in time. The sponsor sought FMD’s help directly. FMD achieved the approval within 10 days while the sponsor allowed 30 days for the application.

  • A French company was running a global phase III cardiovascular trial. FMD was asked to help on the CTA application. We managed to obtain the approval 2 months ahead of target.

  • A European global company retained FMD to file IND for its phase I/II oncology trial. FMD obtained the first-ever approval for phase I/II trial in China while this client started its phase I trial in the US. This is the first such break-through in China for allowing early phase clinical trial conducted inside China almost simultaneously as those going on outside of China. This client has its own regulatory team in China. However its own team was never able to obtain such an approval before.  

  • A German global firm enlisted FMD’s service for filing 4 INDs because its own initial filings were rejected. FMD managed to successfully file all 4 applications.

  • A German global firm enlisted FMD’s service for filing 4 INDs because its own initial filings were rejected. FMD managed to successfully file all 4 applications.

  • Per request by CDE of CFDA, FMD offered trainings to the industry for applying IND via the green Channel. Because of our knowledge and insights, FMD has filed more “green channel” applications than any other CROs in China.

  • Almost all reviewers from the CDE of CFDA and the heads of drug registration departments of provincial/city CFDA have received trainings from FMD as requested by CFDA. Because of this, FMD has a good working relationship with key reviewers and understands their concerns about applications. This allows us to either avoid “request for more information” (a major delaying factor in IND application) or proactively prepare for an effective response to the “request for more information”
    Because of our insights and competent efforts, FMD has generally been able to shorten the IND/CTA application timelines by 2~3 months on average.

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