Nigel Goodman: “I set up Gaea with the experience I gained in the Amgen-Roche Venture Team. Our team had found that by using a validated product profile we could reduce the time taken to move drugs through clinical development to regulatory submission. There has been significant progress in this clinical development, but there is still a lot to achieve. Gaea provides the services of product concept testing and market assessment; the key question being – is there a market worth pursuing? We are not a Clinical Research Organization (CRO) – we work with your CRO. We conduct effective clinical trial site feasibility – an area in which CROs are often weak. We work with your internal Clinical Operations and/or your choice of CRO to represent or support you as a Sponsor.

We offer to help with an effective study start up because a slow start up can reduce morale and the longer a study takes the more it costs in CRO fees.

For ongoing studies, we will work on clinical trial sites of concern, in conjunction with your CRO, to define those issues that are delaying enrolment and to offer solutions. The emphasis of these solutions will be on practical activities to solve the issues and accelerate the enrolment or, if necessary, to recommend closing the site. This can be necessary because non-productive sites cost money in CRO fees.

We also provide regulatory advice and actions in the EU. We offer input on pricing and reimbursement and their implications.

Further detail is found in the next pages.

 
Nigel Goodman, Director