Our TeamMeet our experienced and highly competent team of OA experts, who all have a scientific background with a clear understanding of the clinical science we perform.
At NBCD, we perform all aspects of clinical trials including but not limited to trial design, protocol writing, medical monitoring, data management, regulatory affairs, pharmacovigilance, and trial management. The team at NBCD is highly motivated, and our employee turnover rates are among the lowest in the industry.
Our efforts are focused on innovative clinical trials in the therapeutic area of osteoarthritis, allowing us to provide additional value based on our research-legacy within this area. All team members share our passion for scientific and operational excellence and contribute to the joint mission of developing drug candidates for targeted treatments faster, better, and cheaper, and with a more favorable risk-benefit ratio for patients and payers.
We operate at the forefront of international drug development research and are internationally renowned for scientific and operational expertise.
Clinical Trial Managers
Our team of Clinical Trial Managers holds strong operational expertise, particularly within osteoarthritis, and work effectively and diligently managing all critical aspects of clinical trials. As pioneers in risk-based monitoring strategies, our CTMs work with a risk-based mindset helping sponsors and clients ensuring a thorough and efficient clinical trial conduct. Most of our CTMs have previous experience as CRA’s and can provide valuable insights in site management and trial conduct.
Clinical Research Associates
Our team of Clinical Research Associates are dedicated to assist our sites in conducting high quality clinical trials per GCP and current global and local legislations, while ensuring protection of patient’s rights, safety, and data integrity. At NBCD, we value including our CRAs in most operational processes. Besides site contact management and monitoring, they are involved in site feasibility, site payment management, centralized monitoring, and they engage with our sponsors and clients alongside our CTMs.
Clinical Data Managers
Our Clinical Data Management team work in close collaboration with the operational team across NBCD to provide fit-for purpose data management solutions. With a risk-based mindset and clinical trial experience, they are motivated by delivering world-class clinical databases and premium clinical data for advancing our client’s drug development objectives. Experienced in biostatics our team also provides inhouse programming to facilitate our operational, safety and medical review of trial data, throughout study conduct.
Being experts within OA and the requirements for setting up ePROs, our Data Management Team is highly experienced in working with license holders, our own systems, and eCOA vendors setting up the best possible way to capture and monitor these important data sets for our clinical trials.
Regulatory Affairs and Pharmacovigilance
Our Regulatory Affairs and Safety team appreciates high-quality submissions to relevant regulatory Authorities and Ethics Committees and their experience with competent individual authorities worldwide, including EMA, FDA, MHRA, SFDA and ANVISA ensures a quick regulatory green light. They ensure to stay on top of all updated guidelines and regulations, and in recent time, they have a strong focus getting ready to submit under the new EU Clinical Trial Regulations and CTIS.
Our Pharmacovigilance team covers the entire range of clinical trial safety tasks and responsibilities, independently of, or in close collaboration with, our partner’s internal drug safety department.
Quality Management Team
Our Quality Management team holds broad experience within clinical trial development, inspections and audits and work closely with the operational team across NBCD. Our quality management system is based on ISO 9001 with a strong focus on subject safety and risk management, ensuring quality, integrity, and accuracy of data for each clinical trial we undertake.
The Science Team
Our Science and Medical team is dedicated to developing innovative and high-quality clinical trials, while ensuring the safety of our participants. The team has extensive knowledge from the scientific field of OA, especially within the mitigation of placebo-response and trial design, and they appreciate engaging in scientific discussions.
The Science team is an integral part of Sanos Group, and their scientific knowledge is not limited to OA, but also include osteoporosis, rheumatoid arthritis, and related disease areas. The team is led by Chief Scientific Officer, Asger R. Bihlet, who is an internationally renowned key opinion leader in OA clinical trial methodology and an active participant in several OA scientific advisory boards, as well as a frequently invited speaker at OARSI and similar venues.
Asger and the team consult for sponsors in protocol writing and study design, by providing valuable study specific recommendations and insights based on their extensive OA trial experience with a broad range of sponsors, as well their extensive in-house research projects and our proprietary OA clinical trial database.
The Science team publishes several scientific papers every year, in high-ranking medical journals, aiding the scientific community advancing the development of new treatments for OA.