Regulatory Affairs and Pharmacovigilance
Our first-hand knowledge of and experience with local regulatory agencies and processes facilitate rapid approval of clinical development programs.
Our expertise encompasses obtaining regulatory agency and ethical committee approvals for clinical trials of new chemical, biological entities or medical devices as well as keeping the approvals constantly updated with amendments and annual revisions.
Through our extensive experience with the EMA, FDA, SFDA, ANVISA and many other competent individual authorities and ethics committees globally. We know their preferences and focus areas and how to address their requirements to ensure a quick regulatory green light.
Subject safety and regulatory compliance are our primary concerns when conducting clinical trials. We work closely with our client's own drug safety department to provide safety surveillance and prompt, accurate reporting of serious adverse events worldwide.
Risk-Based Monitoring & Data Management
Our network of committed, well-educated employees enables us to monitor clinical trials on any level requested by our partners.
We are leaders in the use of risk-based monitoring, with several years of hands-on clinical trial experience and a risk-based approach to monitoring, which has led to an unprecedented high level of data quality.
This intelligent method that utilize a variety of monitoring types both centrally and on-site allows us, at an early stage, to identify any quality or safety issues across participating sites. The centralized monitoring approach helps identifying atypical patterns, which would be almost impossible for human monitors to detect by manual review.
We have conducted research on risk-based monitoring and published papers on the subject.
Our trial management team works effectively and diligently to manage all critical aspects of a trial to ensure on-time delivery of results, within budget and with the highest possible quality output.
Our team will work with you on all aspects of the clinical trial - from protocol development through to closeout and final reporting to ensure you and your projects succeed quickly.
The limited number of sites we require for even large phase III trials, and our specialized scientific approach, ensures we can generate first-rate quality data quickly, which saves time in seeking for drug approvals.
Nordic Bioscience Clinical Development has gained a track record of rapid initiation and recruitment of osteoarthritis patients unsurpassed by any other research company through the use of our unique feasibility approach FeasIntel™ and a well-established clinical trial site network.
The sites in our network are all high-recruiting and our organization is tailored to match the pros and cons of high-enrollment sites. We have many years of experience within the regulatory environments in which the sites are located resulting in valuable time saved during the regulatory approval of a clinical trial.
Nordic Bioscience Clinical Development is highly experienced in the development of high-quality protocols, particularly within musculoskeletal diseases.
Being a science-driven organization, data from our own in-house research projects have often proven mutually valuable when entering into industry partnerships and are considered our unique advantage. Our latest innovation is to use our proprietary clinical trials database to identify and emulate the most suitable population for new trials and identify and avoid common recruitment pitfalls as early as possible.
Nordic Bioscience has implemented a quality management system based on ISO 9001 focusing on subject safety and risk management. The system ensures the quality, integrity and accuracy of data for each clinical trial we undertake.
We have never had any major audit findings from any regulatory agency and have achieved positive outcomes from numerous audits at investigational sites managed by Nordic Bioscience Clinical Development.