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Clinical Phase

When entering this most costly and exciting 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.


Average success rates from first-in-man to registration is 11%*. (*Reference 1) Mistakes in the clinical phase can be very costly.


There are some critical issues to consider in the clinical phase which if ignored will be expensive in terms of time.


Our Services

In this busy phase we can help you get ahead with:

 

•Clinical programme advice

• CTA (writing and submission)

• Ethics committee approval

• Recommending opinion leaders

• Recommending a CRO

• GCP mock inspection

• Preparing product information (labelling and leaflets)

• User Testing of Package Leaflets

Can you provide evidence that your product is cost-effective, knowing that post approval you will face the 4th hurdle?

What impact will the NEW Paediatric Regulation have on your clinical programme? A paediatric investigation plan (PIP) needs to be considered as early as Phase 1.

New regulations demand that all Patient Information Leaflets (PIL) for new medicines need to be "User Tested".


Working in association with:

Incrom

Take advantage of our knowledge and experience during this important phase of your product development.
*References
1. http://pipeline.corante.com/archives/2004/09/20/drug_development_the_current_odds.php and http://www.cs.princeton.edu/picasso/abstracts_F06/krishna_files/Kola-Landis2004.pdf
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