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.
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 submission)
• Seeking ethics committee approval
• Recommending opinion leaders
• Recommending a CRO to execute your clinical
trial programme
• Arranging 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? This 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.
Take advantage of our knowledge and experience
during this important phase of your product development.
