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)
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:
Take advantage
of our knowledge and experience during this important phase
of your product development.
