Having performed over 700 studies in the 25 years of its existence, Chiltern (Early Phase) Ltd (CEP) has extensive expertise in Phase I-IIa development, the majority of performed studies being First-in-Man (including POC) and Phototoxicity (in conjunction with Spectratox Ltd, Ninewells Hospital).
STUDY PROGRAMMES
Our Phase I & II research projects have covered a wide range of other studies, such as:
- Bioequivalence / bioavailability studies (single and multiple dose tolerance)
- Food Effect (single and multiple dose tolerance)
- Pharmacokinetic
- Pharmacodynamic
- Drug-Drug Interaction (single and multiple dose tolerance)
- Phase IIa efficacy studies
- All studies are supported by a dedicated team of experienced research nurses and technicians.
REGULATORY SUPPORT
- Access to EMEA & FDA regulatory expertise
- Competent Authority regulatory submissions
- Investigator Brochure preparation / review
- General consultancy & drug development planning / review
ETHICS COMMITTEES
- Access to United Kingdom NRES approved independent ethics committees
- Rapid submission and response
- Patient and volunteer studies reviewed
VOLUNTEER DATABASE
- Extensive database of active healthy volunteers
- Special populations including female, elderly, Japanese
- Volunteers genotyped for metaboliser status (2D6)
- High degree of volunteer compliance
- Access to a wide range of patient groups via GP networks and hospital liaisons
- Ethics Committee approved advertising and recruiting procedures
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