We will create a custom-made ‘route to clinic’ plan for your cell or gene therapies - all designed to get you to the clinic as fast as possible.
Our team of specialists have a deep understanding of the specifics of cell and gene therapies and a unique approach to the development of non-clinical safety programmes, which means you can spend more time on the things that matter.
Our approach
Our in-house approach has been developed to help take the headache out of risk assessment, due diligence and gap analysis.
How we can help
- Oversight and implementation of your non-clinical safety programme, helping you get it right, first time.
- Preparation of the non-clinical section of your regulatory documentation including investigational medicinal product dossier and Investigator’s Brochure.
- Access to our network of industry specialists, who can help ensure your programme ticks all regulatory requirements.
We have supported the design and implementation of non-clinical safety programmes for pluripotent stem cell therapies, somatic cell therapies, immune therapies, genetically modified cell therapies, tissue engineered products and medical devices.
Our support
- Report providing a full review and gap analysis of the non-clinical programme and a recommendation for a path to clinical trial application.
- Non-clinical study management support including protocol generation, study monitoring and report preparation for pivotal non-clinical safety studies.
- Outsourcing and oversight of pivotal GLP safety studies.
- Preparation of non-clinical section of IMPD and support in regulatory agency interactions.
Case studies
- Design and oversight of non-clinical programme for an SME resulting in successful and quick CTA approval.
- Gap analysis and innovation office meeting support for an academic group resulting in an MHRA approved non-clinical plan. The non-clinical programme successfully supported CTA approval.
- Due diligence on a non-clinical programme for a pharmaceutical company facilitated study rationalisation and a reduction in the non-development phase.
The process
Contact us to find out more about our non-clinical safety capabilities.
