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Joel Hale
Director of Clinical Affairs
January 2019
Device CRO for small startup?
< 1 min reading time

Any recommendations for a great CRO with ENT device experience who understand the unique challenges associated with a small surgical device company? Would prefer they have their own EDC system and also work in Germany.

Thanks in advance,
Joel

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Posted by Joel Hale
Asked on January 29, 2019 10:01 am
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Annabella Jucius

I highly recommend using NAMSA. It's small/mid-size med-device focused CRO based in Minneapolis. They have an office in Germany.

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Joel Hale

Thanks very much Annabella!

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JeanMarie Markham

Joel, we are a MedDev CRO with an office in Germany - Mainz. If you are still considering options. Work with many small start-ups

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Alethea Wieland

Hi Joel - happy to give you some advice from establishing numerous successful, Sponsor-CRO partnerships over the years, including medical devices. Please connect with me at alethea@clinicalresearchstrategies.com, call me anytime day or night at 724.272.1245, or check out how we mitigate risks in all aspects of CRO selection. We do it right the first time. Alethea Wieland, Founder and President, www.clinicalresearchstrategies.com/about.html

ps - here is a recent article I wrote on avoiding cost overruns and rescue trials: https://www.linkedin.com/company/clinical-research-strategies/

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Robert Packard

Hi Joel,
You might consider Factory-CRO in Netherlands. They have lots of experience working with small / start-up companies including several of my client. They have ENT experience, and experience working in Germany. They also offer an EDC hosted on their own servers that is 21 CFR part 11 compliant. Finally, they recently acquired a second small medical device CRO in the US--Boston Biomedical Associates.

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