In the clinical phase, a drug is tested to see if it has an acceptable toxicity and safety profile, as well as the desired effect. Extensive experience and clear advice helps products emerge from clinical trials with strong evidence to support marketing authorization.
Omni-EDS provides the exceptional clinical strategy from its highly experienced experts. We conduct a gap analysis to understand your needs and design the best clinical development strategy. Our team develops a Product Development Plan to outline all the key aspects of an effective program. Omni-EDS partners with you to create a clinical program that is streamlined and will give the product the best opportunity to demonstrate safety and effectiveness.
Early clinical Phases I–II are key for determining next steps, as well as satisfying regulators and reassuring stakeholders. Our focus on early-phase expertise and collaborative culture provide consistency and continuity during these early critical trials and the transition to a full CRO partner. Whether testing dose ranges, investigating dose-response or dose frequency through pilot studies, or pursuing other safety and efficacy characteristics, our clinical experts will deliver for you.
Every clinical investigation begins with the development of a clinical protocol. Each Omni-EDS protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of your clinical trial. We provide a wide range of therapeutic protocol development assistance, follow Good Clinical Practice (GCP) guidelines and are in compliance with regulatory requirements.