WHAT SETS OUR BIOANALYTICAL LAB APART?
For more than 15 years, Worldwide Clinical Trials has been a trusted market leader in bioanalysis. Our personalized approach means that from discovery to post-marketing, we partner with your team to develop customized solutions, whether that is:
- a custom method;
- transfer/optimization and validation of an existing method;
- identifying challenges and de-risking a regulated assay; or
- adapting a method to increase efficiency, sensitivity, specificity, and cost-effectiveness.
We know your early phase development comes with high stakes, and we take that seriously.
Our scientific heritage not only means we have accessible expertise to work closely with you, but also means we are compulsive about quality. Our new state-of-the-art facility was constructed with a holistic vision of bioanalytical service requirements, encapsulating both large and small molecule processing combined with powerful analysis tools including multiple bioanalytical platforms.
Large Molecule Capabilities
- Method development
- Method transfer
- Method qualification
- Method validation
- Sample analysis
- Monoclonal antibody
- Antibody drug conjugate
- Bispecific antibody
- Fusion protein
- Gene therapy
- Reagent generation/labeling/characterization
- Assay and sample management
- Logistic support
- Data analysis
Our bioanalytical lab is flexible in productivity and can accommodate analysis based on your study’s requirements. State-of-the-art instrumentation and more than 2,400 validated assays make Worldwide industry leaders in bioanalytical method development and validation. Our bioanalytical work meets all regulatory standards, including:
- FDA Regulations (US Code of Federal Regulations, 21 CFR) for Good Laboratory Practice, Good Clinical Practice (GCP), Bioavailability and Bioequivalence Requirements, conduct of clinical trials, and human subject protection.
- European Clinical Trials Directive 2001/20/EC and Commission Directive 2005/28/EC.
- UK Medicines and Healthcare Products Regulatory Agency (MHRA) requirements.
Our quality assurance and quality control processes add another level of oversight.
24/7 SPECIMEN CONTROL
We are dedicated to maintaining the integrity of your specimens by providing a 24/7 call list and accommodating emergency retrieval on nights and weekends. We ensure that every biological sample is properly collected and handled to avoid pre-analytical errors. We can provide custom labels to minimize sample discrepancies, which is especially helpful for multi-site studies.
Upon receipt of samples:
- Containers are opened to ensure all samples are frozen and intact.
- Samples are logged into our Watson Laboratory Information Management System (LIMS) database and given a unique identification number to track them through all stages of preparation and analysis.
- The temperature of each -20°C or -70°C freezer is monitored by both Tyco Integrated Security as well as a Vaisala continuous data logger.
Our site has capacity for nearly 1 million samples at any given time.
AREAS OF SCIENTIFIC EXPERTISE
- Multi-analyte assays, including metabolites
- Unstable analytes, including prodrugs
- Enantioselective assays
- Low-level (sub pg/mL) quantitation
- Immunocapture and enzymatic hydrolysis
- Microsampling, including plasma microcapillaries and dried blood spot analysis. Exploratory bioanalysis (tissues, CSF, synovial fluid) for site-of-penetration and target organ studies
BIOANALYTICAL SUPPORT SERVICES FOR YOUR PEACE OF MIND
- Method development, feasibility, and validation
- Drug discovery
- Nonclinical toxicokinetic studies
- Pharmacokinetic (PK) screening
- Pre-clinical animal and clinical sample analysis
- Dose-escalating studies
- Clinical PK/bioavailability studies
- Bioequivalency studies
- Bioavailability studies
- First-to-file studies
- Drug-drug interaction studies
- AME and protein-binding studies
- Metabolite profiling
- Pharmacogenomics screening