We specialise in phase 1 trials of investigational medicinal products (IMPs). We’re accredited by the MHRA to do all phase 1 trials, including ‘higher risk’ trials.
- First-in-human trials – about one-third of our trials involve the very first administration of an IMP to humans
- Bridging trials – we’ve an experienced team of 15 bilingual nurses and graduates dedicated to Japanese bridging trials; we’ve also done bridging trials in Chinese and Korean volunteers
- Ascending dose trials – we offer rapid turnaround of data, and robust procedures for dose escalation
- Radiolabelled IMP – ADME, microdosing and ‘light label’ trials– our radiopharmacy and on-site laboratory make us the ideal centre for trials of radiolabelled IMP
- PET – we collaborate with Invicro, Hammersmith Hospital, on PET and fMRI trials
- ‘Umbrella’ protocols – single/multiple ascending doses, incorporating food effect and special populations (eg women, ethnic groups, patients)
- Bioequivalence and bioavailability
- Evaluation of biosimilars and ‘bio-betters’
- Pharmacodynamics and biomarkers – we use a wide range of clinical and laboratory methods
- Drug interactions
- Thorough QT
- Specialist trials: audiometry, sleep, endoscopy, respiratory function
- Special populations
- elderly
- postmenopausal
- surgically sterilised
- smokers
- ethnic groups
- obese
- alcohol-dependent
- genetic polymorphisms