We design the appropriate Clinical Development Plan that aligns with, and supports, our Clients’ objectives.
How do we do this?
We listen to our Clients' vision for their product, ensure we understand how their drug works and how the data obtained can inform the next steps for development. We work with the Client's team and Key Opinion Leaders (KOLs) to design a Clinical Development Plan for the product that has the potential to support and deliver the companies’ aims. This is key. And this is our expertise.
With our expertise, we are able to design the individual clinical studies that underpin the Development Plan - the Phase 1, 2 and 3 clinical studies.
Individual studies will be customised to the objectives of each study with a focus on:
- Study design (randomisation, placebo/comparator controls, blinding)
- Study population (animal species, healthy volunteers, special patient groups, intended patient population, inclusion/exclusion criteria)
- Number of participants/subjects
As required, the following support documents are available for an individual study:
- Project plan (budget, timeline, milestones)
- Responsibility and accountability plan
- Resource plan
- Monitoring plan
- Recruitment and retention plan
- Vendor management plan
- Safety management plan
- Data Safety Monitoring Board (DSMB) charter
- Data management plan
- Statistical analysis plan
- Risk management plan
- Communication plan
- Publication plan