Clinical Trial Applications
We have a dedicated clinical trial application team within our development group. This team have orchestrated and submitted clinical trial applications across many EU countries and for a wide range of product types.
Our team have experience in the UK, The Netherlands, Germany, France, Spain and Belgium for trials related to small molecules, biologics and advanced therapies. We manage the clinical trial applications for a diverse range of clients from biotech companies running a single clinical trial through to pharma companies with more than 30 new applications per year and a large volume of substantial amendments.
Advanced therapy medicinal products developers face additional challenges, both operational and technical, when designing and executing regulatory strategies for these products.
In particular, those products classified as genetically modified organisms (GMO) will be subjected to a GMO permit application. This is an additional permit that must be obtained prior to the initiation of a clinical trial.
As with clinical trial applications, the GMO application is also submitted to each individual EU member state in which the clinical trial is to be conducted. The processes for obtaining the GMO permit can vary significantly between member states.
Given our leading position in advising gene and cell therapy clients, our team are very familiar with the latest national expectations for these clinical trial applications and also for ancillary procedures such as GMO applications and the authoring of related technical documents such as Environmental Risk Assessments.
We provide comprehensive support to our clients’ clinical development and regulatory teams and we specialise in helping US clients opening their programmes in Europe. We lead agency interactions through the application process, negotiate pragmatic solutions towards approval and support regulatory compliance programmes throughout the clinical trial. The team can provide both outsourced CTA department coverage as well as specialist ad hoc advice to the Regulatory and Clinical teams within client companies.