Nossos Associados

Established in 1982, Chiltern is a leading global Contract Research Organization with extensive experience conducting and staffing international Phase I to Phase IV clinical trials across a broad range of therapeutic areas for a wide variety of clients.

Chiltern has conducted trials in more than 40 countries, has 24 offices and legal entities within 20 countries, resources in 37 countries and employs nearly 1,400 people globally.

Chiltern provides the following services:

Early Phase

Chiltern Early Phase is one of the oldest clinical pharmacology units specializing First-In-Man and Phototoxicity studies in the UK. Our team has performed more than 700 studies, covering a wide range of pharmacokinetic and pharmacodynamic studies in all the major therapeutic areas and routes of administration.

Global Clinical Development.

Chiltern's Global Clinical Monitoring personnel ensure that the most up to date procedures and strict quality control are adhered to while working with the latest technology. Dedicated local line managers recruit, train and manage clinical monitoring staff to global standards and monitor quality to ICH-GCP, the clinical study protocol, client specific requests and Chiltern Standard Operating Procedures.

Late Phase

Our Global Late Phase Group of specialist project managers and experienced clinical development professionals are focused on providing specific services designed to support products from the point of approval/marketing authorization through launch and beyond. Our global expert teams provide Phase IIIb and IV, non-interventional, observational, epidemiology, investigator-initiated trials and registry services worldwide.

Biometrics

Chiltern offers traditional paper CRF and eCRF services for both stand-alone data management projects and full service clinical programs. Our database programmers design databases to specifications, including CDISC/CDASH, to meet specific statistical and regulatory requirements as well as those of our clients. We partner with the industry's leading EDC vendors including Datalabs® – EDC/CDMS, Medidata Rave® and Phase Forward's Inform™.

Medical and Regulatory Affairs

Chiltern provides expertise either as an independent team or working alongside the client's own management from early stage research through to product launch. Chiltern's contribution to projects can range from the strategic planning of critical paths to applying for clinical trial and marketing authorizations. We have extensive experience in providing due diligence programs and full pharmacovigilance services for licensed and unlicensed products.

Resourcing Solutions

Resourcing Solutions is a leading business unit within Chiltern designed to offer fully integrated solutions to your staffing needs. Our expertise within the industry combined with the back-up of our global CRO capabilities, mean that we have an in-depth understanding of your job specifications, qualification requirements and relevant work experience.

Please visit www.chiltern.com