SMERUD was formally incorporated on 9 May 1993. The sole founder was Knut T. Smerud, who at the time was the Medical Director of Bayer Norway, a position he had held since 1991, after leaving a similar position at Eli Lilly Norway where he had obtained his initial pharmaceutical industry training. Back in 1993, there were literally no other CROs established in Norway offering mainly clinical operations services, so Knut Smerud saw a business opportunity to position a new company in this niche market, with virtually very little competition at the time.
During the first few years, the company grew organically to some 5 employees in Oslo. It took on more and larger projects, again covering study start-up, site management, monitoring as well as local project management of typically large, multicentre, and multinational phase 3 studies, sponsored by big pharma. One such client was obviously quite pleased with SMERUD’s performance and asked us whether we would be prepared to take on a new study, this time covering all Nordic countries. Thus, in line with company ambitions, we accepted the challenge, and in a few hectic months between December 1996 and January 1997, SMERUD expanded from having one to four locations, one in each of the main four Nordic countries.
In parallel with the organic growth of those local clinical operations, we expanded by taking on additional functional service groups: regulatory affairs had been an ‘in-born association’ with the clinical operations from the very beginning, but the maturing of our business also saw a need to provide services within clinical data management and medical statistics. By the turn of the century, SMERUD was well established as a small, but full-service organisation with 25 employees.
The 2000s continued to be an upward trend, and our focus on biostatistics as a stand-alone service unit resulted in a full acquisition of a small company, Statinet AS (now operating as SMERUD Statinet AS), allowing us to provide basic and advanced CME credited training courses in medical statistics. Along the same route, SMERUD was among the consortium partners for a Norwegian Research Council-funded Centre for Research-based Innovation, the Statistics for Innovation (sfi2), which was a highly profiled activity in 2007-2014. Organic growth continued, and new assignments allowed us to open wholly-owned subsidiaries also in Poland (2005), the UK (2006), and Russia (2008). The company grew tremendously during that decennium, and we reached our peak, in terms of size, towards the end of 2007 when there were 93 permanent employees on the payroll.
SMERUD’s ambition was to build an international headquarters in Oslo, aiming to host a wide range of full-service unit managers and clinical research scientists covering a handful of different therapeutic areas. In 2003, we therefore invested in a 100-year-old manor house (which had previously been the home of a wealthy family, later housing as diverse activities as a night club, bank, and law firm) in the west side embassy district of Oslo, which was fit-for-purpose. A small clinic was opened (Forskningsklinikken AS), and a training and conference center was established, enabling us to host periodic seminars to the biotech/clinical trial sector. Smaller biotech companies and consultants were among our tenants. Despite huge ambitions and deep investments, we realised towards the mid-2010s that the value of the property itself would be better monetised by selling it off to professional developers.
However, towards the end of the 2000s, a new market situation arose in our home markets: big pharma had for a few years actively reduced their investment into large clinical endpoint trials in the Nordic area, partly because of relative cost issues, presumably also because other countries, larger and cheaper, had improved their ability to deliver high-quality clinical trial to the big pharma industry. Not only did the number of studies being planned for in the Nordic countries decline with some over a 5-year period, but the financial value decreased even more, since phase 3 studies were replaced with much smaller and shorter, and therefore less expensive phase 2 trials.
Thus within only a short time, we were left in a situation with many highly qualified employees, but with a significantly reduced backlog of contracts year-by-year. Rather than making a huge number of colleagues redundant, SMERUD was able to re-organise its business so that those professionals who were sufficiently experienced and had suitable academic training, were allocated to new SMERUD R&D hubs, established in Oslo, Uppsala, and Manchester. In these R&D hubs, rather than waiting for the market trend to change, SMERUD pro-actively and counter-cyclically invested in-kind resources into clinical trials, offering such services mainly to cash-strapped small biotech companies, typically start-ups or spinoffs.
Being already professionals in medical writing, SMERUD soon gained a strong position in identifying relevant public R&D grants for small-to-medium-sized enterprises (SMEs). Many such calls required collaboration among R&D-performing SMEs across several European borders. SMERUD’s ability and willingness to not only write winning proposals, but also actively participate as partners and not only subcontractors, lifted us to an unrivaled position in this very attractive, but complex niche market. Our first grant success was obtained in 2010, when we together with Swedish med-tech company Alimenta AB and Sahlgrenska University Hospital in Gothenburg, won a huge EUROSTARS grant to develop a companion diagnostic within Irritable Bowel Syndrome. EUROSTARS was at the time promoted as the ‘Champions League for SMEs’, a slogan which was too tempting for our CEO to resist, being a football fanatic.
Since this initial success in raising grant money to our co-development projects, SMERUD continued to actively engage in similar set-ups throughout the 2010s. By 2017, we had secured no less than 10 EUROSTARS grants in a varied range of therapeutic areas, of which 8 were finally launched. More importantly, EUROSTARS had by then become more of the Sunday League (or domestic 2nd division) to use the football terms; and the larger, EU-funded Research and Innovation Action grants (like the FP7 program, Horizon 2020 and nowadays Horizon Europe) had become the new ‘Champions League’ or perhaps ‘a European Super League’. After participating as a standard partner in two major grants of this kind, one for the development of IGF-1 as a prevention of retinopathy of prematurity, and the other a project in acute coronary syndrome; the time had come to take a lead role in such a huge undertakings. In 2016-2017, SMERUD played an essential role in the planning, writing, and execution of two successful Horizon2020 grants: one for the development of a new orphan drug for cystic fibrosis; the other for re-purposing of a drug for rare, eye disorder, namely Stargardt’s disease.
During the 2010s, SMERUD further opened subsidiaries in Austria, Hungary, and Germany, but also closed non-successful subsidiaries in Russia and Hungary. From 2015 to the present day, the company has consolidated its fee-for-service business but continued to invest into co-development prospects. Today, we are heavily engaged in such projects within oncology, metabolic and rare diseases, dermatology, and even neonatology, as well as personalised/precision medicine and in vitro diagnostics. Our classical CRO business unit is healthier than ever, with a solid backlog, and a number of long-term perspective preferred provider ship contracts with key clients.