The Smerud Medical Research Group (SMERUD) has been involved in approximately 2000 large and small projects since company inception in 1993. SMERUD has not specialized in any particular therapeutic area, but in planning and execution of clinical research in early phase clinical trials of new, innovative compounds. In the latter years, we have nurtured two speciality groups within the company, one for early-stage oncology and in particular precision oncology/companion diagnostics, and the other for rare diseases in general, and associated orphan and ultra-orphan drug development.
SMERUD was the first Contract Research Organisation (CRO) to establish themselves with offices and staff in all major Nordic countries (Norway, Denmark, Sweden and Finland), and since then has also established wholly owned subsidiary units in Austria, Germany, United Kingdom, Poland and the US. During the last decade SMERUD has documented its commitment to Research & Development (R&D) by opening an internal research department for clinical development of our own assets (drugs or medical devices/diagnostics licensed from co-development partners), as well as financing industry-academia partnership PhDs.
The core competency of the organisation is expert consulting in addition to operational services from clinical proof-of-concept trials through pivotal studies, and subsequently local support for marketing authorisation application. Despite being a relatively small CRO, SMERUD has developed a full-service organisation offering all operational services needed to develop a drug from first-in-man (FIM) until compiling the application for marketing authorisation. Due to our limited size, for complete clinical development prospects, we have focused on orphan or ultra-orphan products – for which we take responsibility for the entire product development plan, and for regulatory agency and Key Opinion Leader liaising. Of particular importance is our clinical development strategy experience, including regulatory and statistical aspects, which we utilise in identifying a time and cost-efficient plan with the aim of keeping the project right on the critical path.
SMERUD has maintained a client-focused and flexible attitude. SMERUD acknowledges and values the close collaboration with sponsor companies throughout the development process. We maintain a partnership philosophy with our clients but are nevertheless compliant with agreed milestones. Dedication to the projects, and a clear vision of professional pride, make us important providers of clinical development services. SMERUD has been selected as a development partner by a number of biotech and biopharmaceutical companies, resulting in provision of expanded services and repeat business to those clients.
The company as a whole employs about 35 professionals that are full-time and permanent employees. In addition we have a network of some additional 10-15 pre-selected and qualified freelance CRAs and local regulatory and clinical trial start-up specialists, who may be added to our group e.g. when conducting studies outside our domestic market and/or for managing peak resource needs of temporary nature. Our staff has experience from international pharmaceutical or biotech companies and are primarily university graduates and post graduates in pharmacology, physiology, medicine, biology and biochemistry. All employees are routinely trained and re-trained in a wide variety of Standard Operating Procedures (SOPs) and to the latest international Good Clinical Practice (GCP) guidelines. Our SOPs reflect the latest The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines for GCP.
In order to adapt to client needs and new market opportunities, SMERUD has developed a dual business model, so that in addition to the classical fee-for-service CRO business described above, we have invested heavily into a second business division. This division is acting more as a drug/device developer providing cash from its service business units to allow investing into internal R&D projects. SMERUD started as a typical CRO but over time has grown its internal R&D arm, investing almost all of our profit generated through the fee-for-service CRO contracts into internal R&D projects. In this way, the company adds value to various product development ventures, and benefits financially through sharing a part of that value generation; either through joint venture single purpose biotech spin-off companies, in which SMERUD owns shares, or through a contracted buy-out clause in which SMERUD is paid significantly more than a normal fee-for-service contract. However, SMERUD is in this way also sharing the risk (of a failed development program), and is as such a true co-developer and not a subcontractor. Through this dual business model, SMERUD has – together with its associated 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.