Clinical Development

Clinical trials are an exciting stage of drug development, the fruition of years of hard work. Timing is important to their cost-effective execution, and by working with our scientists, clients can front-load clinical timelines as early as the preclinical phase.

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In order for trials to be successful, it is important that assays and testing methods used in the nonclinical lab transition easily to the clinical phase. Drawing from our broad portfolio of laboratory support services, our scientists have the capability and the experience to develop and transfer methods efficiently and expeditiously to meet the needs of our clients. In many cases, our scientific staff have been an integral part of our clients’ drug development from the earliest stages of nonclinical work. This ongoing relationship results in a deep understanding of a client’s work, and fosters continued collaboration across the clinical study team. Combined with our data management and transfer expertise,this approach allows us to produce detailed, on-time clinical data to support drug approval and help our clients effectively make sound go/no-go decisions.

As clinical trials begin, further in vitro and in vivo nonclinical studies performed within our global network of facilities provide additional information to support the continuation of clinical trials.

Over the years, we’ve made significant investments in highly trained scientific, technical and support staff, superior facilities and technologically advanced instrumentation. These combined give us the ability to rapidly produce reliable data for many types of analyses using networked, validated data management systems.

Our comprehensive laboratory support services include:

Our complete range of clinical pathology laboratory services supports animal models, discovery, preclinical studies and/or clinical trials with extensive knowledge of animal and human hematology, coagulation, clinical biochemistry and urinalysis. Specialized pathology laboratory services are available for assays/biomarkers for specific research requirements or drug safety studies.

Our staff, including pathologists certified by the American College of Veterinary Pathologists and the European College of Veterinary Clinical Pathology, has expertise across the spectrum of major therapeutic areas and routinely assesses and interprets data from regulatory and investigative/research studies. With six state-of-the-art clinical pathology labs, we can support all stages of the human and veterinary drug development process and conduct research in accordance with the current GLP and GCP standards.

We have more than 20 years of experience in manufacturing viral vaccines. From challenge virus preparation to clinical scale vaccine manufacturing, our cGMP-compliant manufacturing capabilities complement our testing services to provide a comprehensive portfolio of services for vaccine development from a single, harmonized source.

Our exceptional team of scientists regularly designs and performs safety programs ranging from acute through chronic toxicity to carcinogenicity, with a broad range of animal models and numerous routes of administration.

Our specialty toxicology services include: