Our current team has first-hand experience in a wide range of designs involving Japanese volunteers.
Thorough-QT (TQT) studies
Glucose/Insulin clamp studies
Studies in Japanese volunteers with hyperlipidaemia
Adaptive umbrella studies incorporating:
single and multiple ascending dose
age/gender comparison and ethnic bridging studies
Between 2008 and 2016 we randomised an average of 170 Japanese subjects every year in studies of varying study designs with short-term and long-term residency periods.
Our recruitment database is the largest in Europe containing a panel of over 7,000 1st generation Japanese subjects, of which approximately 65% are active, i.e. they;
Meet the PMDA established criteria
- Japanese passport holder
- 4 x Japanese grandparents
- outside Japan for less than 6 years
Are enrolled in an on-going study
- have registered in the last month
- or are signalling an interest in study participation within 3-6 months
Bridge the gap in your next clinical study
By gathering Japanese data sets from Phase I, potential ethnic variations can be detected early on adding value to subsequent global development programs. Richmond Pharmacology has the experience and expertise to empower bridging strategies. Through our track record of accepted submissions we have built up a strong relationship of trust with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and have an in-depth understanding of the specifics needed to submit a complete clinical data package.
Japanese clinical team
Richmond’s experienced in-house Japanese team, accounting for 20% of our workforce, includes a Japanese GMC registered doctor, nurses, study managers and recruitment staff who are involved in all aspects of your study. The large contingent of Japanese staff facilitates good communication, accurate reporting of adverse events and helps our volunteers feel comfortable and looked after by a team that understand their concerns and needs.
Experts in Japanese recruitment
Applying the PMDA concept to other Asian volunteers, our database currently has 1,894 non-Japanese Asian volunteers, of which 72% are active.
The Japanese and pan-Asian recruitment process is supported by targeted community outreach campaigns and our long standing and well-known brand trials4us and trials4japanese, generating many new pan-Asian and Japanese registrations each month. Our London location provides access to one of the largest concentration of first generation Asia-Pacific populations outside of their countries, including Japanese, Chinese, Korean and other Asian populations.
Richmond's team has a varied cultural background, approximately 40% are Asian. Our dedicated in-house team of Japanese clinical and recruitment staff, accounting for 20% of our workforce, are sensitive to the cultural needs of our volunteers and manage their experience from initial contact throughout study participation. This facilitates good communication, accurate recording of adverse events which is an important factor, e.g. for the assessment CNS effects. Our retention rates are second to none, with all studies conducted in the last three years completing with the full complement of volunteers administered with study medication barring those withdrawn for medical reasons (1%).
Optimum safety is assured by our unique hospital integrated setting with access to 24-hour emergency and acute medical services assuring best medical practice, safeguarding the reputation of sponsors and investigators.
Richmond Pharmacology's Principal Investigators have had hands-on involvement in each and every study conducted at our clinical trials centre and offer a wealth of valuable experience in this field. Through our track record of accepted submissions we have built up a strong relationship of trust with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and have an in-depth understanding of the specifics needed to submit a complete clinical data package. As frequent visitors to Japan and contributors to Japanese annual scientific meetings we are recognised and respected within the industry.
For more information on how we can enhance your global development contact us at: email@example.com or speak to our BD Team on +44 (0) 20 7042 5808