Richmond Pharmacology

Bridging Studies in Clinical Trials

Bridging Studies

Richmond Pharmacology has completed over 60 successful protocols involving Japanese subjects since 2002, significantly more than any other UK and European clinical pharmacology unit.

 

As a long established provider of Japanese and ethnic bridging studies, our current team has first-hand experience in a wide range of designs involving Japanese volunteers, including;

  • First-in-Man studies
  • Thorough-QT (TQT) studies
  • Glucose/Insulin clamp studies
  • Studies in Japanese volunteers with hyperlipidaemia
  • Adaptive umbrella studies incorporating;
  • single and multiple ascending dose
  • food effect
  • drug-drug-interaction
  • age/gender comparison and ethnic bridging studies

Between 2008 and 2013 we randomised an average of 160 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 5,800 1st generation Japanese subjects, of which approximately 65% active, i.e. they;

  • Meet the PMDA established criteria;
  • Japanese passport holder
  • 4 x Japanese grandparents
  • outside Japan < 5 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

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 longstanding 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 baring 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: info@richmondpharmacology.com or speak to our BD Team on +44 (0) 208 664 5200

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