Biology Services: Preclinical GLP

Biology Services :: Contract Research (CRO) :: GLP CRO Service

Welcome to Biology CRO informational resource for life science and pharmaceutical researchers. This website provides a list of contract research organizations (CRO) that offer various pharmacology and biotechnology laboratory services to pharma/biotech industry and academic research centers.

A contract research organization or CRO is a company that provides outsourced research services, typically laboratory-based or analytical, to pharmaceutical, biotechnology or medical device manufacturers. Among the services they provide are preclinical research, development of drugs, in vitro and in vivo studies, assay development, commercialization work, and management of clinical trials.

CRO companies often work closely with research institutes, universities, governmental organizations, and other entities involved in pharmaceutical and health research. CROs vary in size from large multinational organizations with the resources for large-scale clinical trials to small companies with expertise in specific assays or processes. For example, with the use of high throughput RNAi screening methods, CRO laboratories can test specific gene functions, or even perform screens of an entire genome in a relatively short period of time – recent scientific breakthrough in gene silencing research has revolutionized both the scale and speed with which gene and protein function is studied today.

CROs that maintain quality systems called good laboratory practices (GLP) or good manufacturing practices (GMP) can be used to perform studies to support regulatory filings such as Investigational New Drug (IND) applications – regulated by federal agency FDA in USA.


Molecular and Cell Biology Laboratory Services (Company):

Preclinical CROs are able to support laboratory testing related to basic molecular biology needs, including tissue culture experiments (IC50, transfection, ELISA assays), validating cell lines, extraction and isolation of nucleic acids, optimization and monitoring of gene expression, and characterizing proteins needed by the sponsor’s research needs. Cloning a gene of interest into the appropriate vector and expressing it to appropriate level can be a large undertaking that could be laborious and expensive. Reporter gene assays may are also often performed providing information on the level of the protein of interest. Molecular data from the results of microarray assays or PCR experiments may be integrated into safety assessments. Outsourcing of this tedious molecular biology work may save precious time your company needs to concentrate on analyzing data and planning the next experiments.