Bioanalytical
Make informed decisions, faster with Worldwide Clinical Trials’ Bioanalytical Laboratory
WHAT SETS OUR BIOANALYTICAL LAB APART?
For more than 15 years, Worldwide Clinical Trials has been a trusted market leader in bioanalysis. 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.
BIOANALYTICAL SUPPORT SERVICES
Bioanalytical services
- AME services
- Assay methods search
- Bioanalytical lab (Austin, TX)
- Biomarkers
- Clinical PK/bioavailability studies
- Drug discovery
- Drug interactions
- LC/MS/MS
- Method development & validation
- Method qualification & transfer
- Nonclinical toxicokinetic studies
- Pharmacogenomics screening
- Pharmacokinetic (PK) screening
- Plasma protein binding studies
- Preclinical and clinical sample analysis
New state-of-the-art bioanalytical facility
- 60,000 sq. ft. laboratory building located in Austin, TX
- One hour travel time by car to our 200-bed Clinical Pharmacology Unit
- Expansion initiative to increase capacity and improve workflows
- GLP and Part 11 Compliant: Support Regulated Bioanalysis (Clinical Studies, GCP)
- Successful FDA Inspection History
Our Dedicated Team
Dr. Tom Zhang
Chief Scientific Officer, Large Molecule Bioanalysis
Our large molecule bioanalytical lab is headed by Dr. Tom Zhang, industry recognized large molecule bioanalysis expert. Dr. Zhang is responsible for:
- Evaluating and recommending analytical platforms in support of quantitative large molecule work.
- Actively promoting technical development programs to keep Worldwide at the forefront of technology in support of large molecule bioanalysis.
- Maintaining state-of-the-art knowledge pertaining to large molecule bioanalytical methodologies.
Dr. Andrew Cunningham
Vice President, Laboratory
Andrew has managed laboratories for more than 30 years across an array of service providers. His management experience includes:
- Leadership of a system of pediatric hospitals
- Several multi-site clinical laboratory networks
- Oversight of global laboratory operations for several CROs and trial sponsors in the translational research space
Andrew has scientific and laboratory experience in such therapeutic areas as oncology, immunology, hematology, and cardiovascular disease, with early research work focusing on leukemia biology, stem cells, chemotherapy, antisense, immunophenotyping, and apoptosis.
Dr. Leimin (Perry) Fan
Associate Director, Method Development
Perry has worked in the pharmaceutical industry for more than 27 years and is experienced in analytical support in CMC development, ADME, preclinical and clinical bioanalysis. His current responsibilities at Worldwide Clinical Trials are:
- Leading the method development group to generate robust and sensitive analytical methods to support sponsors’ preclinical and clinical studies
- Leading the efforts in the bioanalysis lab on improving automation and introducing new technologies
- Supporting validation and production on troubleshooting and process improvement
Dr. Jason Hamilton
Associate Director, Method Validation
Jason has nearly 20 years of laboratory experience spanning clinical, research & development, and analytical testing laboratories, along with five years of experience managing laboratory teams. His experience includes:
- Leading the method validation group at Worldwide to ensure robust and sensitive analytical methods are in place to support sponsor studies
- Setting-up and leading analytical testing, purification, production, and development operations as well as the quality program for a medical cannabis operation
- Developing methods for the analysis of biomolecules and pharmaceuticals