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Welcome to Smerud Medical Research

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 100% one-family owned, 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’.

 

FEE-FOR-SERVICE CRO

The company was founded back in May 1993, so we have 28+ years of profitable operations, covering all significant therapeutic areas. However, being a relatively small company with, we primarily focus on our expertise areas:

•         Geographical niche: North-Western Europe

•         Planning, conduct, analysis and reporting of early-stage clinical trials 

•         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’.

 

PRODUCT DEVELOPMENT & FINANCING

Profit generated from this fee-for-service CRO business unit is to a large extent re-invested into our own drug development programs. 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 secures some 50% of the investment needed for a clinical trial, generating a favourable investment case when seeking additional funds from venture capital. SMERUD has – together with its associated venture firm Scandinavian Biotech Venture AS – become one of the largest private biotech investors in the Nordic countries with an accumulated investment close to 10 m€ by mid-2021.

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) within the consortia, with a dedication and responsibility in delivering the project as per agreed plans.

SERVICES

At SMERUD, we are capable of offering anything from management of an entire clinical drug development programme, to provision of a stand-alone functional service in one study or project, only. Having played a role in developing drugs for 28 years, we have acquired full-service expertise in the planning, conducting, analysing and reporting of clinical trials, and we fully understand the critical importance of quality, time and cost in such projects. SMERUD is proud to offer our clients a comprehensive portfolio of functional clinical trial services. 

 

 

STUDY PHASES

We deliver our service in all clinical study phases

  • Phase 0: microdosing studies
  • Phase I/Ib: First-in-Man and First-in-Patients studies
  • Phase IIa: clinical Proof-of-Concept studies
  • Phase IIb: dose-response studies 
  • Phase III: therapeutic confirmatory studies
  • Clinical validation/utility studies

 

 

FUNCTIONAL SERVICES OFFERED

  • Clinical Project Management
  • Feasibility analysis
  • Regulatory affairs
  • Site management and monitoring
  • Data management
  • Biostatistics
  • Pharmacovigilance & medical monitoring
  • Medical writing
  • Clinical trial supplies
  • QA & auditing
  • Training
  • Legal representation
  • Consulting

 

 

Individual functional services are presented in more details below, whereas for integrated, full-service assignments we develop a tailor-made plan for the specific project as per our SMERUD SYSTEM™. The SMERUD SYSTEM™ is a proprietary project management system scaled to fit our needs, typically managing phase II trials, but should larger trials be requested, we can easily scale up our management tools.

 

Key to the success of a full-service project is the Project Manager. The project manager will break down the project goals and scope into deliverable components, compile a project plan and associated documentation and oversee the work of the project team to ensure the timely delivery of project-specific milestones.  The project manager will be the main contact for our client and will provide routine project updates on study progress.

 

The project team will be assembled following award of the contract and determination of the country in which the trial will be conducted. In general, in order to keep costs to a minimum it is recommended that a flat team structure is implemented according to the following model.

 

 

OFFICES

Smerud Medical Research Offices

  • International Head Office - Oslo
  • Norway - Oslo 
  • Sweden - Uppsala
  • Denmark - Copenhagen
  • Finland - Espoo
  • UK - Manchester
  • Germany - Mannheim
  • Poland - Warsaw
  • For more details, please visit our Locations page.