Our ServicesNBCD offers all aspects of protocol development and clinical operations
NBCD is highly experienced in the development of quality protocols, particularly within OA.
Being a science-driven organization, data from our own in-house research projects have often proven valuable in our industry partnerships and are considered one of our unique advantages. Other than being experts in OA pain and placebo response we 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.
NBCD has gained a track record of rapid initiation and recruitment of osteoarthritis patients, unsurpassed by any other research company, using 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.
Trial & Project Management
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 high quality data quickly and efficiently, saving time in seeking drug approvals.
Risk-Based Monitoring & Data Management
Our committed, well-educated employees enable us to monitor clinical trials on any level requested by our partners.
Within all our processes we have embedded the industry and regulatory requirements for a risk-based approach to clinical trial conduct.
We are leaders within risk-based monitoring, with 10+ years of hands-on clinical trial experience using a risk-based approach to monitoring and data management. This has led to successful conduct and reporting of numerous high data quality projects.
This intelligent method that utilizes a variety of monitoring types both centrally and on-site and by numerous in-house functions 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 monitors to detect by manual review at the clinical sites.
We have conducted research on risk-based monitoring and published papers on the subject.
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, MHRA, CFDA, ANVISA and many other competent authorities and ethics committees globally. We know their preferences and focus areas and how to address their requirements to ensure a rapid regulatory green light.
Being a knowledgeable organization, eager to learn, we ensure to stay on top of all updated guidelines, regulations etc. and have a strong focus in recent time to prepare to be able to submit under the new EU Clinical Trial Regulations and CTIS.
Subject safety, medical monitoring and regulatory compliance are some of our primary focus areas when conducting clinical trials. We work closely with our partners own drug safety department to provide safety surveillance and prompt, accurate reporting of serious adverse events worldwide.
NBCD 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 our own team performing internal and external auditors and welcome numerous partner audits every year.