UNDERSTANDING CLINICAL RESEARCH
Chiltern Early Phase team is uniquely placed to collaborate with Clinical Research Units (CRUs) to perform a full range of early phase First-In-Man (FIM) and exploratory development studies including proof of concept and translational medicine studies to the highest standards of safety and quality.
We bring our specialized experience and skills to assist our partners in designing, managing, monitoring, and analyzing early phase studies. Chiltern Early Phase team has amassed extensive experience in this area and we are a symbiotic partner with clients seeking to outsource Phase I study activities. Similar to Chiltern’s Therapeutic teams, Chiltern Early Phase team has the expertise in all elements of early phase studies, regardless of therapeutic areas. This team may be part of the proposed budget, or may function in the background in an advisory capacity.
Most independent CRUs are limited to the recruitment and execution of a protocol with minimal biometrics capabilities. Following an exhaustive search of the highest profile CRUs in the US and Europe, Chiltern has now selected to partner with a small number of CRUs that have undergone a complete vendor qualification initiative and validated through our stringent quality assurance process as qualified and approved vendors for Early Phase services. Our Early Phase team works with these CRUs to offer specialist services in:
- Regulatory affairs - Phase I studies usually require opening of an Investigational New Drug (IND)
- Project management
- Study design and consultancy
- Site selection for both commercial and institutional CRUs
- Study management at CRUs including independent monitoring
- Data management / electronic data capture with an emphasis on laboratory and analytical results
- Statistical support including fundamental pharmacokinetic analyses
- Medical writing
- Pharmacology expertise
- Data safety monitoring board
- Medical support by our team of experienced physicians
Our team has extensive experience in studies involving healthy volunteers, patient populations, FIM, TQT and bridging studies. They have worked in a broad range of therapeutic areas that include but are not limited to:
- Allergy / Asthma
- Cardiovascular
- CNS
- Dermatology
- Diabetes
- Gastroenterology
- Hematology
- Infectious Diseases
- Renal impairment
- Ophthalmology
- Respiratory
- Vaccines
Chiltern will provide and maintain the resources, equipment, standard operating procedures, and documentation at the center while performing the clinical trial in close collaboration with local investigators. Utilizing this model, Chiltern Early Phase team can plan and perform all studies in conformity with the clinical study protocol and in full compliance with Good Clinical Practice standards. Together with our partner CRUs, we are able to offer customized, turn-key services from IND to New Drug Application (NDA) for your Early Phase trials.
