Richmond Pharmacology

Adaptive Clinical Trial Design

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines.

The quickest way to Proof of Concept

 

The use of adaptive study design in early phase studies is beneficial as it allows time- and cost-efficiencies whilst ensuring optimal safety. Richmond Pharmacology actively works to maximise return on our Sponsors trials, having routinely developed and conducted adaptive protocols for over 6 years.


Benefits of using Richmond Pharmacology

  • Collection and analysis of relevant and essential data only to meet objectives within a limited budget
  • Adding value by gathering more and highly relevant data
  • Fast and efficient adaptive protocol development using a transparent & systematic 3-step approach
  • Streamlined study conduct from set up through clinic to final clinical study report
  • Immediate implementation of adaptive changes as long as they are within the authorised adaptive scope
  • Efficient scheduling of adaptive ‘umbrella’ protocols using essential data outputs for early decision making
  • Tailor-made study specific adaptive limits and control mechanisms to manage potential risks
  • Limitation of assessments and participant exposure to what is relevant and essential

Set-up

  • Unremitting Phase 1 accreditation since 2008
  • Located within large London NHS hospitals with immediate access to acute medical services

Experience

  • Long-term practical adaptive study design and conduct expertise
  • At the forefront of published innovative study adaptive designs
  • Frequent presentations at conferences and workshops

We are

  • Reputable: Known to regulatory agencies in EU, USA and Japan
  • Personable: Richmond’s team of senior early phase drug development experts personally look after every study and closely interacts with sponsors throughout

Latest Publications

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines. Lorch et al. BMC Medical Research Methodology 2014, 14:84

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines. Lorch et al. BMC Medical Research Methodology 2014, 14:84 http://www.biomedcentral.com/1471-2288/14/84

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The practical application of adaptive study design in early
phase clinical trials:The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings. Lorch et al. Eur J Clin Pharmacol (2012) 68:543-551

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