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Company Profile

Smerud Medical Research International AS (SMERUD) is a European drug development company and contract research organisation (CRO) with headquarters in Oslo, Norway. We help our clients to run cost-efficient clinical development programmes.

The core competence is strategic drug development including regulatory affairs planning. We manage clinical exploratory trials, proof-of-concept trials (phase IIa) as well as pivotal phase III trials, and we liaise with regulatory agencies world-wide to agree study plans. SMERUD has been involved in more than 900 clinical trials. The core business idea is to develop biotech drug candidates in collaboration with small-to-medium sized biotech partners. Our CRO division employs about 65 persons, of whom 60 are clinical research professionals. SMERUD is ideally sized and experienced to be a preferred partner for biotech companies in terms of managing early clinical trials in a cost-effective setting. The SMERUD group is present as a fee-for-service consultancy in 10 European countries, whereas our self-financed R&D hubs are thus far only located in the UK (Manchester) and Norway (Oslo). Since 2009, we have invested internal R&D time into some 25 major clinical research projects, with a total accumulated investment of approx. 70 mNOK. Our portfolio of clinical research projects has focused on therapeutic areas with which we have previous experience, and/or those for whom our R&D personnel have a particular expertise. Over the last 6 years, our main R&D programmes have included biomarker-directed therapy in oncology, long-term complications of kidney transplantation, skin infection, hormone replacement, cardiovascular morbidity in inflammatory joint disease, cystic fibrosis, as well as nano-technology based drug delivery systems and nasal drug delivery for neuro-active drugs.

SMERUD’s second core business area is being a commercial Contract Research Organisation (CRO), and thus we provide highly experienced and qualified clinical trial managers, quality controllers, biostatisticians and data managers as well as regulatory affairs professionals for projects related to drug development.  Such professionals are employed in sister/daughter companies in Norway, Sweden, denmark, Finland, the UK,  Germany, Poland and Russia.

OUR PRIMARY EXPERTISE


Pivotal clinical development programmes
Proof-of-concept studies
Dose-response studies
Phase IIIa therapeutic confirmatory studies

Biometrics
In-house data management and biostatistics unit

Regulatory affairs
Marketing authorisation applications including local translation and harmonisation of texts
Clinical trial applications
Pharmacovigilance
Medical writing

Quality assurance
Site audits
In-house audits
Development of standard operating procedures
Training courses

Investigator-initiated trials
Administrative support (e.g. applications, protocol writing, reporting)
Quality control
Data management and statistics
Fundraising / grant applications


For more information, please see our Services page.

OUR APPROACH


Smerud's trial management is cost-effective, client-focused and flexible - allowing intimate control over study progress.

Our innovative study designs are aimed at exploiting scarce funding for early phase trials, employing expert strategy consultation and implementation.

We adhere to agreed targets with dedication and reliability; and present the resulting data accurately and comprehensively.

OUR PEOPLE


Smerud's enthusiastic team is highly educated, particularly in scientific, medical and pharmaceutical fields.

The group boasts strong expertise in pharmacology, physiology, medicine, biology, biochemistry, nursing and medical administration. This is derived from specific experience working with international pharmaceutical and biotechnology companies; multinational contract research organisations; academic research companies; and medical and research charities.

All employees are trained to the industry guidelines for Good Clinical Practice (GCP). These guidelines are reflected in the company's standard operating procedures (SOPs).


For more information on each unit, please visit our Locations page.