Securing Scientific Advice

The Client…

• was a small start-up company with limited in-house resource
• needed to define the optimal clinical programme and assemble evidence to support the registration of a novel delivery device for a well-established product
• needed to present the evidence to EMA to obtain Scientific Advice

…so what we did was…

• design and conduct a literature search, and review over 150 articles on the use of similar types of device in this and other therapeutic areas
• summarise the literature evidence and write a position paper confirming the unmet need for an alternative delivery mechanism
• define the clinical studies that would be required to show evidence of efficacy and improved patient compliance

…and the outcome was…

• the Client was delighted with the report which was considered to be comprehensive yet user-friendly
• the EMA meeting was successfully negotiated and the Client was able to move its clinical study programme forward with confidence
• the Client has commissioned four further projects with Spectrum

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