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.
Will you be including the molecular characteristics of the patient’s cancer in inclusion criteria? Are all of the protocol-defined procedures appropriate for collecting data that will support a new drug application or investigational medicinal product dossier? Thoughtful design can aid in defining biomarkers to facilitate later-phase enrollment. We can help you develop novel methods to accelerate proof of concept, determine dose escalation and titration regimens, and adhere to globally consistent quality standards for patient safety and regulatory guidelines.
Phase I-IIA Therapeutic Portfolio
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Phase IIB-IIIB Clinical Trials
Ariocell 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.
We counsel in both regards ― leveraging experience with comparable challenges. In a quest to introduce patient populations who are more representative of that intended for marketing, exclusions in Phase III trials should be closely examined and carefully justified. There are powerful reasons to enroll more representative patient samples, to facilitate better estimates of efficacy and safety across treatment settings.
Planning Early for Market Success
The planning process for commercialization now begins shortly after the onset of clinical investigation, following regulatory submission. We can help you supplement or complete trials to better define product characteristics, investigate quality of life or healthcare utilization issues, explore marketing strategies which acknowledge differences in standards of care internationally, or plan for Phase IV evaluations which are either mandated as part of a regulatory post marketing commitment, or envisioned under the concept of “line extension”.
Global Experience, Local Expertise
In a highly international clinical trial environment, an ability to use regional differences in standard of care and thus patient access to clinical trials is a differentiator for any CRO. Because of our highly differentiated geographical footprint, characterized by “in country” clinical experts who are familiar with language, culture, and standards of care, our ability to operationalize clinical studies for “difficult to find, difficult to treat patients” is exceptional.
Phase IV Clinical Trials
Understanding the reasons behind product success in a clinic setting and the marketplace is essential. Ariocell 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.
We offer our clients expertise in:
Trials to support marketing claims, new indication or label changes
Registries and observational studies
Outcomes, Epidemiology & Risk Management