A traditional CRO is globally represented and is financially interested in a study model where as many as possible investigational sites are involved. It costs on the average 40’000 USD to open a new site and the site management fee is independent of the number of patients recruited at that site. It is well known within the business that a very large proportion of the selected sites do not enroll any patient at all and that the average number of recruited patients per site is about 4. The monitoring thus becomes highly ineffective and very expensive per patient. Furthermore, the quality of the data suffers from the inconsistency that will always exist between different sites. Nordic Bioscience’s clinical study management work in a completely different way. The head office is located in Herlev, Denmark. Through the long-lasting collaboration with CCBR-Synarc’s research and patient recruitment clinics it is possible to perform study monitoring in an outstanding cost-effective way. The CCBR sites are professional and large with large number of patients which increases the efficacy of the study monitors (Clinical Research Associates, CRA’s).
There are hundreds of small biotech companies that need a partner like Nordic Bioscience when they enter phase II and III. In clinical trial management Nordic’s specialty is projects from smaller biotech companies with limited know-how in clinical development and limited funding. Nordic’s scientific orientated, small and efficient team and structure can meet the requirement for low cost in return for IP or other upside models. The Nordic model is among other factors based on a long-lasting work relationship with CCBR-Synarc for patient recruitment, central lab and image analysis functions and with local CRO’s around the globe. Nordic provides clinical trial know-how and management for almost all levels in the clinical development process
Our dedicated Clinical Development department offers all aspects of Clinical Trials for Pharmaceutical Companies, Biotech
companies and for our own drug candidates:
- Study Feasibility
- Protocol Design
- Study Management
- Monitoring
- Pharmacovigilance
- Data Management
- Statistical Analysis
We have performed trials from Phase I to III.
- All staff members have a scientific background which is constantly being stimulated and developed and we therefore understand the importance of the clinical science
we are doing. - We work with a network of high-enrolling dedicated clinical trial centers that ensure rapid quality recruitment on a small number of sites with centralized quality assurance.
Due to the limited number of sites we require for even large phase III studies and the central quality control combined with our scientific approach we can ensure very high
data quality in short time, which leads to faster approvals.
We have handled more than 10.000 patients in our clinical trials.