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Company Profile

  

Our core competence is expert consulting related to the clinical development plan and specifically to proof-of-concept trials (phase IIa), thus in clinical development where biomarkers play a pivotal role. We are therefore experienced in developing and validating clinically, new and emerging biomarkers, prognostic markers and companion diagnostics. Our functional services are primarily focused on clinical project management and monitoring of phase II-III studies, regulatory affairs, data management, statistics, medical writing and general drug development consulting. The company has been operating for more than 24 years, and been involved in more than 1000 clinical trials in a wide variety of indications, countries and study phases. We have about 60 clinical development professionals employed, and our international management team consists of seniors with experience from the international biotech/pharmaceutical industry, academia as well as the consultancy business.

 


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. Being a relatively small company and operating in transparent markets, SMERUD has maintained a client-focused and flexible attitude acknowledging the typical close collaboration that sponsors often prefer in the early trials. We value the partnership philosophy, but are nevertheless compliant with agreed milestones. Our project managers have been carefully selected and trained to understand the quality and result-oriented environment in today’s contracting market. Dedication to the projects, and a clear vision of professional pride, make us important providers of clinical development services in Europe and lately also Canada.

 

 

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.