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Clinical Trials
When entering this most costly phase, make sure that you
are working with real experts. We will champion your product
and remain dedicated to the project until your medicine has
reached the market and is benefiting patients.
There are some critical issues to consider in the clinical
phase which if ignored will be costly in terms of time.
Our Services:
In this busy phase we can help you get ahead by:
• Advising on your Clinical programme
• Managing your CTA (writing and submitting)
• Seeking ethics committee approval
• Recommending opinion leaders
• Recommending a CRO to execute your clinical
trial programme
• Arranging Mock GCP inspection
• Preparing Product Information (Labelling and
Leaflets)
• User Test Package Leaflets
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Critical Issues to be aware of:
Can you substitute confirmatory clinical trials with pharmacodynamic studies?
Have you considered obtaining Scientific Advice from the regulators for your immunogenicity issues?
What impact will the NEW Paediatric Regulation have on your
clinical programme?
Take advantage of our knowledge and experience
during this important phase of your product development. |
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