SMERUD is providing senior clinical development expertise to the market. The majority of our clients in the consulting market are small-to-medium sized enterprises, typically with very strong drug discovery, laboratory and/or pre-clinical modelling experience, but with relatively scarce experience from clinical development. In most cases, the client would present to SMERUD their current overall idea about their target indication and target market. SMERUD’s consulting unit would then typically be assigned to establish ‘the optimal development strategy’, materialized through a detailed, integrated Clinical Development Plan (CDP). The CDP would include the desired Target Product Profile (TPP) and a detailed description of all activities to be completed in order to attain the attributes defined in the TPP, and with associated crude budgets. The timing of all activities including deferral of non-critical activities until completion of clinical proof-of-concept would be outlined.
The CDP/TPP would form the basis for regulatory dialogue (incl. formal Scientific Advice Meetings) with the Competent Authorities, for consultation with global, regional and national Key Opinion Leaders, and for early business development activities with potential (big pharma) industry partners. It is our experience a thorough CDP will be a valuable complement to the Business Plan, when start-up companies or other SMEs are pitching their concept and offer to potential investors, whether smaller family offices in the earlier financing stage or more professional investors and VC alike, in later stages.
Key elements in our consulting business:
- Identify and interpret international and any national regulatory requirements and guidelines
- Identify clinical society guidelines
- Literature search
- Assessment of available data on product
- Identifying regulatory requirements for target indication(s)
- Clinical development plan
- Individual project planning, costing and co-ordination
- Competitive intelligence
- Due diligence for product licensing
- Strategic Innovation Funding (grant review and application planning)