In our experience a clinical development programme must answer 6 key questions:

1. What is the unmet medical need for the intervention and in which population?
2. What is the evidence to support the dose, and what is the minimal effective dose?
3. What evidence to prove there is efficacy?
4. What is the safety profile?
5. What is the risk-benefit ratio - on balance, does this intervention do more good than harm?
6. What is the statement of the intervention's value? - why should health systems use scarce resources to purchase it?

Services Include:

The organisation, facilitation, and minutes for Clinical Expert Meetings to gain expert input to study design: patient population, comparators, end points, duration of treatment and study feasibility – how many patients- how many sites – which countries- what competing studies.

Contacts to Regulatory Consultants for Europe and the USA

Identification of possible Clinical Trial Investigators from previous clinical studies, and publications

Services of Clinical Document QC

Provision of CRAs and Project Managers

Global CROs not cost effective for phase II studies involving few countries. Clients try to reduce CRO budgets but they usually only achieve that by CROs reducing service levels, such as CRA hours on site. This may produce a poor result or a large additional cost for “change orders”- work that had to be conducted that was not in the original budget. Gaea provides clinical resources on contract to set up and manage studies in Europe.

©Copyright Gaea Pharma Ltd 2002