Worldwide Solutions
We help navigate the rapidly evolving clinical development landscape
Ready to learn more about Worldwide? see our service offerings below!
Our personalized approach means we truly partner with you across the entire lifecycle of product development and commercialization.
BIOANALYTICAL SERVICES
Our team provides quality service with rapid turnaround at a competitive cost. You can rely on strong scientific expertise at our Bioanalytical Laboratory in Austin, Texas. From discovery to post-marketing, we partner with your team to develop a custom method, transfer/optimize and validate an existing method, identify liabilities and de-risk a regulated assay, or adapt a method to increase efficiency and cost-effectiveness.
EARLY PHASE I CLINICAL TRIALS
Whether you’re testing dose ranges on healthy volunteers or on cancer patients, conducting pilot studies to investigate dose-response or dose frequency, or pursuing numerous other safety and efficacy characteristics, our clinical experts can help. Phases I–IIa are critical for determining next directions as well as satisfying regulators and reassuring stakeholders. Our significant early-phase experience and teamwork culture provide consistency and continuity. Dedicated staff keep their skills current with ongoing training.
- Phase I Clinical Trials
- Bioequivalence
- Clinical Research Unit (San Antonio, TX)
- Pharmacokinetics
- Pharmacodynamics
LATE PHASE II-III CLINICAL TRIALS
Worldwide Clinical Trials has customized phase II-IIIB clinical trial services, which can be deployed on a stand-alone basis or as a full-service CRO solution, create scalable, flexible programs based on experiences with other programs ― across therapeutic areas—that help avoid pitfalls. Phase II-IIIB is often scrutinized for potential trimming to shorten timelines or to reduce the level of investment necessitated by a need to dose range across the fewest number of patients, with disease characteristics which would optimize signal detection. Proceeding with Phase II programs that neither define a clinically useful dose range, nor patient characteristics predictive of response enhances the possibility of Phase III failure.
- Phase IIA-III Clinical Trials
- Feasibility / Protocol Development
- Biostatistics
- Clinical Monitoring & Site Management
- Medical Monitoring
- Data Management
- Drug & Supply Depots
- Drug Safety & Pharmacovigilance
- Medical Writing
- Method Development /Validation
- Patient Recruitment / Retention
- Project Management
- Quality Assurance
- Rater Services
- Regulatory Affairs
LATE PHASE III-IV CLINICAL TRIALS
Understanding the reasons behind product success in a clinic setting and the marketplace is essential. Worldwide Clinical Trials specializes in the design of peri-approval studies focused exclusively on this issue. After evaluation of the study objectives we create a study tailored to your needs, enabling you to consider drug efficacy in treating additional indications, support promotion claims through publication data or evaluate your product against a competitor.
- Phase III-IV Clinical Trials
- Drug Safety & Pharmacovigilance
- Outcomes, Epidemiology & Risk Management
- Registries & Observational Studies
WORLDWIDE EVIDENCE
Our Worldwide Evidence practice documents the clinical, economic, and humanistic value of innovative drugs and devices before and after product approval and launch. With uncommon technical expertise and decades of practical, strategic perspective, our experts work to objectively and credibly establish evidence of value in actual practice (real-world) settings, using operational techniques that increasingly embrace advanced technology.