METHOD DEVELOPMENT & VALIDATION

METHOD DEVELOPMENT AND VALIDATION:
A COMMON CHALLENGE, BUT IT DOESN’T HAVE TO BE

Analytical method development and validation is critical to pharmaceutical development and achieving the reliable analytical data you need to reach your next development milestone. Method development and validation can be complex, costly, and labor-intensive. A good understanding of current regulatory expectations and relevant chemistries coupled with advanced instrumentation is critical to developing efficient, accurate, and reliable analytical methods.

DOES YOUR CRO GO BEYOND THE STATUS QUO?
WORLDWIDE HAS THREE DECADES OF UNMATCHED EXPERIENCE

We know you have a choice when selecting a partner for your method development and validation needs. It’s important that your partner offers more than the status quo. Worldwide strives to be the Cure for the Common CRO, meaning we are delivering uncommon value – recognized by customers for quality, budget, staff, and delivery. And, we are winning awards for our ‘uncommon’ service.

Worldwide Clinical Trials has been awarded the distinct honor of Overall Top-Performing CRO by Industry Standard Research and Life Science Leader. Our experience developing methods and validating them for 3 decades is what makes us truly uncommon. Our competitors can’t make that claim. When you need experts in the field, look no further than Worldwide Clinical Trials.

To date, we have many validated methods in alignment with regulatory guidance. Our services include:

• Extensive ruggedness testing
• Seamless method transfer
• Method adaptations and/or optimization for future sample analysis
• Custom / strategic assays for drugs and their metabolites or biomarkers
• Fit-for-purpose method qualification
• Plasma, blood, urine, tissues, cerebrospinal fluid (CSF), free fractions (protein binding) and rare matrices
• Microanalysis/sampling (dried blood spots, Mitra™, capillary, intracellular)
• Microflow liquid chromatography (LC)
• Low level of quantitation (sub-low pg/mL)
• Multi-analyte assays
• Unstable molecules (including prodrugs)
• Method validation

We believe in trust, communication, and leadership. When your method development and validation program need quick, nimble, quality support – look no further than Worldwide Clinical Trials.