Critical development milestones delivered with ease
At Worldwide Clinical Trials, we have been operating and delivering study results for nearly 20 years and have the experience, expertise, and proven ability to accommodate your clinical pharmacology needs from start to finish.
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Meeting clinical pharmacology study timelines to complete your full NDA package while working on your pivotal Phase III study is a challenging requirement. As you plan for future development, our team at Worldwide is here to support you.
- Dedicated teams for full clinical pharmacology studies
- Expert advice on study design, including protocol and analysis plan development to accommodate conventional and nonconventional products
- Fit-for-purpose facility co-located with our bioanalytical lab for efficient timelines and streamlined processes
Full Suite of Clinical Pharmacology Studies
- First-in-Human
- Integrated SAD and MAD (includes FE / DDI / BA / EPQT)
- Drug-Drug Interaction
- BE / BA
- Food and Meal Timing Effect
- PK / PD
- AME / Mass Balance / Metabolite Profiling
- Renal Impairment
- Hepatic Impairment
- Expert Precision QT and Thorough QT Evaluations
- POC Studies in Patients
- CSF Collection and Analysis
- Specialty Studies (Biopsies: muscle and skin, NG tube, unique routes of administration)
