Gaea | Clinical Ltd
One Broadcarr Road
SK11 0AQ
United Kingdom

Gaea Clinical Trial Services LLC
97343, Saint-Petersburg,
ul. Matrosa Zheleznyaka, 57A, 122N

Tel: +44 1625 413 900
Fax: +44 1452 798 222
Mobile: +49 151 51 11 19 31

Clinical Operational Reviews

Issue Identification and Proposed Solutions

Gaea is able to conduct independent and comprehensive operational reviews of clinical projects, to identify issues that are affecting start up and/or enrolment.

On the basis of our experience in phase III issue management, through a combination of discussion, observation and interview, many issues can be identified that, combined, result in slow start-up and then (usually) slow enrolment as the sites' momentum is slowed.

An example of previous experience is outlined in our prior oncology work, where a country-by-country and subsequent site-by-site review is conducted to detect issues such as: inadequate country or site feasibility assessment, competing studies, lack of site resources, concerns with IMP handling or administration or financial concerns.

Gaea works with the Sponsor and CRO team to resolve overall project issues and with to try and resolve non-productive site issues, with practical solutions. In some cases, closure will be proposed if it is clear that the site cannot deliver.

Examples of our successes can be seen in both our news items and the enrolment services page.

Our Recent Clients

Glycotope GmbH
DNAtrix Inc.
Genelux GmbH
Vifor Pharma UK Ltd
CureVac GmbH
MucoVax GmbH
BN ImmunoTherapeutics
Oncolytics Biotech Inc.
Cougar Biotech Inc.
Agios Inc.
Drug Royalty International
Allos Therapeutics Inc.
The Medicines Company, Inc.
Adventrx Inc.
Baxter Bioscience, Inc.
Merck Serono Oncology

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