Real World Evidence
Our team provides quality service with rapid turnaround at a competitive cost. You can rely on strong scientific expertise at our Bioanalytical Laboratory in New Delhi. 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 Development
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.
CLINICAL PHASE IIB-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 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 IIIB - PHASE 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.
REAL WORLD EVIDENCE
Our Worldwide EvidenceTM 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.
TECHNOLOGY
It's a simple truth: well-integrated technology enhances clinical development. So when partnering with a SMO, look beyond the promises to the facts. Is there an elegant and validated clinical trial management system? Do interfaces among various tools such as EDC, IxRS, and statistical analysis facilitate interaction and communication? How does integration occur? Does the SMO offer a comprehensive electronic shelter for your clinical trial?