A European full-service CRO
Project management | Regulatory affairs | Monitoring| Data management | Biostatistics | Pharmacovigilance | Medical writing
The Smerud Medical Research Group (SMERUD) is a leading, commercial clinical Contract Research Organisation (CRO) providing full-service clinical trial services to biotech, pharma, med-tech and academic sponsors. We primarily operate in Northern Europe with headquarters in Norway and subsidiary offices in Denmark, Finland, Sweden, United Kingdom, Germany, Austria and Poland. Thus, our clients will benefit from our local presence and point of contact and also full access to our firm’s overall expertise and experience.
The company is owned by a ‘family office’, and this guarantees ownership involvement, orientated towards long-term perspectives and leveraging of the client-provider relationship, including a personalized approach. We are passionate about clinical trials and consider the development of a study protocol or a study report as nothing less complex and beautiful than art, aiming for perfection in the final document. We are very proud of our highly competent and well educated staff, most of whom could claim seniority in the business of drug development.
We look at professional pride as a key value and our promise to clients and employees is that we will always adhere to premium business ethics and aim to deliver first class quality in all our services. Being innovators and entrepreneurs in several areas, we remain committed to our corporate vision: ‘Semper excelsior’.
The company was founded back in May 1993, meaning that we have provided high-level services and generated value in a high number of assets through profitable operations, covering all significant therapeutic areas for 30 years in a highly competitive and changing market. Through the many decades of operations, we have learned that whatever we do, it has to be among the best on a world scene. Rather than aiming for a huger size (‘been there, done that’), our philosophy remains loyal to what it was some 30 years ago: never compromise on quality, and maintain a never-say-die attitude. Our mission is to plan, conduct, analyse and report all of our projects – big or small – with the same approach and attention to delivery of high-quality services and product development.
We provide all services needed to conduct a clinical trial, including clinical project management, feasibility analyses, clinical study protocol writing, clinical trial applications (CTIS and NRAS), clinical operations incl. monitoring and site management, biostatistics and data management, pharmacovigilance, medical monitoring and writing of the clinical study report and publications arising from the study. Our Regulatory Affairs unit offers general regulatory affairs services, regulatory intelligence and strategy, scientific advice meetings, orphan drug designation applications and a limited clinical supplies services. Further, we offer legal representation, training, QA and GCP auditing services.
Being a relatively small company with some 35-40 headcounts, we primarily focus on our niche expertise areas:
- Clinical trials in the Northern Europe (the Nordic Area + the UK, Germany and Poland)
- Planning, conduct, analysis and reporting of clinical trials, primarily in phase I and II
- Management of full clinical development of orphan drugs, including regulatory strategy and consultations
- Securing public R&D grants for early-stage clinical trials
Our experience and size, makes us and ideal provider to biotech companies sponsoring early clinical stage trials, fulfilling one of our slogans ‘Big enough to manage, small enough to care’.
CLINICAL DEVELOPMENT CONSULTING
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 clinical 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 that 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.
PRODUCT CO-DEVELOPMENT, CO-FINANCING and INVESTMENT
Profit generated from our fee-for-service CRO and consulting business units is to a large extent re-invested into our own drug development programmes. We have developed an innovative business model in which we may partner with selected biotech companies, wherein SMERUD invests in-kind a significant part of the clinical trial costs, allowing our biotech partner to spend their cash more efficiently. Such co-development contracts typically secure some 50 per cent of the investment needed for a clinical trial, generating a favourable investment case when seeking additional funds from venture capital. SMERUD has – together with our integrated small-cap venture firm Scandinavian Biotech Venture AS – become one of the larger ‘family office’ biotech investors in the Nordic countries with an accumulated investment of more than 10 m€ in cash by end 2022 and a significant additional in-kind commitment over the coming years.
As part of this co-financing and co-development strategy, SMERUD has achieved an unrivalled position in Europe as the consultancy, which not only successfully writes grant applications for clinical trials but is also committed to being an active partner (beneficiary) and co-investor within the consortia, with a dedication and responsibility to utilise our professional expertise and experience in delivering the project as per agreed plans.