Strategic Medical Support for Clinical Development Planning and Implementation

Scientific Advice:

We can support you in your interactions with regulatory agencies in planning clinical trials and responding to regulatory questions. For therapies to treat rare diseases it is especially important to engage early with agencies to optimise study design and minimise cost.

CTA/IND applications:

If you are planning to apply for clinical trial authorisation (e.g. in the EU) or investigational new drug application (US) we can review the data so far, and help to compile the key messages in your data package to improve your chances of success.

Clinical Development Planning:

Partnering with Pharmora from the planning stage can help you to streamline the programme so that key milestones are timed to suit your needs. For example you may need some data quickly to support grant funding applications, or you may need a structured long term plan and a signal of efficacy to attract large pharma partners. We can help you make the most of every penny to get through to the next investment milestone, all for a fraction of FTE.

Medical Monitoring:

Quality by design is now written in legislation and the regulatory agencies will expect you to consider how to ensure data collection and safety monitoring is conducted to the highest standards. By partnering with us from the planning stage our clients have found they have saved money and achieved timelines ahead of predictions.