Bridging Studies – What You Need to Know

October 24, 2013 -- Bridging studies are clinical trials conducted for purposes of comparing the effects and safety of IMPs in various ethnic groups. These studies can assist sponsors in obtaining earlier approval for their IMPs in countries such as Japan and are provided in pharmacological organizations all over the world by teams comprising of experienced nurses, doctors, study managers and recruitment staff, all of whom are involved in every aspect of the study. Bridging studies teams are in turn supported by the clinical and operations teams.

Bridging studies may be conducted on subjects of various nationalities, and thereafter used in regulatory submissions in the respective country. For instance, bridging studies on Japanese subjects are employed in regulatory submissions in Japan. The teams behind these bridging studies gain experience in First-In-Japanese, Single-Dose, Single Ascending Dose, Multiple Dose, Multiple-Ascending Dose, as well as combined Single and Multiple Dose protocols.

Professional pharmacological organizations will employ a uniquely successful approach to volunteer advertising and recruitment for bridging studies which ensures that they are able to recruit a variety of volunteer populations that are representative of the nation’s population, as required by the respective Licensing Authorities. For instance, the pharmacological institution will recruit various Japanese volunteer populations that are representative of the Japanese population, in accordance with the regulations of the Japanese Licensing Authorities.

If you are looking to partner with a pharmacological organization for bridging studies, consider a long standing provider with years of experience in carrying out numerous simple and complex bridging studies. If the pharmacological organization is based in Japan, for example, it should preferably have a large team of Japanese staff, including a specialized Japanese recruitment team that accounts for20% of the work force at minimum.

Go for a pharmacological institution with a good track record for fast and efficient recruitment. When you partner with the right pharmacological organization, you will be able to enjoy access to the largest active 1st generation Japanese volunteer panel for bridging studies in Europe. Such an institution would have partners in respective countries such as Japan for purposes of facilitating better collaboration with Japanese sponsors. With such an institution working with you side by side, you will be able to obtain universally accepted clinical trial data.

The recruitment of subjects for clinical trials is a priority for pharmaceutical companies when choosing the country and clinical research organization (CRO) to award the conduct of their study. Most delays during the conduct of clinical trials are often due to insufficient subject recruitment. This in turn results in delays in compound development timelines, which causes the company to spend more than they planned on R&D.

While most CROs around the world are able to conduct healthy volunteer trials, trials in specific populations, in particular trials of healthy Japanese volunteers require careful consideration with regards to geographic and CRO-specific placement. It is therefore imperative to partner with the right CRO that can carry out bridging studies to provide you with the right data for your clinical trial.

Richmond Pharmacology’s Bridging Studies - A flexible team of expert Principal Investigators who closely run and manage studies. With many years of experience, Richmond Pharmacology is able to provide a full service under one roof, getting things done well in the quickest time possible.

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