UNDERSTANDING CLINICAL RESEARCH
Since 1982, our clinical team has routinely managed and delivered many successful Early Phase studies covering a wide range of pharmacokinetic and pharmacodynamic studies in all the major therapeutic areas and routes of administration. In addition to First-In-Man and Phototoxicity studies, we have experience in:
- Drug-drug interaction studies
- Proof of concept / Efficacy studies
- Bioequivalence / bioavailability and food effect studies
- TQT studies
- ADME studies
- Japanese bridging studies
Our clinical team has worked closely with many Ethics Committees and managed volunteer and patient recruitment strategies that are customized to the requirements of each study. In addition, we have a team with significant experience in supplying data to the regulatory authorities in Europe, Japan and USA to ensure that we offer a seamless service including regulatory affairs service to all our Early Phase clients.
As Chiltern is a leading full service global CRO, our clients benefit from a wide range of in-house support services such as data management, biostatistics, medical writing, clinical monitoring, quality management, pharmacovigilance, regulatory support and contract staffing.
We have fostered excellent relationships and partnered with many leading clinical trial vendors to provide integrated solutions for all your Early Phase study requirements when there is a need to engage the vendors.
Chiltern’s experienced team of project managers, physicians, clinical research associates, regulatory consultants and scientists approach every Early Phase study with safety, precision, quality, compliance and timeliness in mind to ensure that all studies are performed to the highest ethical and clinical standards.
