Having conducted over 1800 clinical trials, including 25 first-in-human (FiH) trials in the last 5 years, our expert early phase team at CRS Clinical Research Services is ready to provide exceptional support for this critical stage of your product’s clinical development. Based in Germany, CRS has the experience and facilities to ensure your Phase I trial is conducted safely and effectively and are well-placed to advise in every aspect of the study, from feasibility and study design to trial management, recruitment, execution, and close-out.
Robust data collection procedures at CRS ensure thorough and prompt evaluation of your product’s safety, thereby allowing efficient and informed decision making. Their agile operations teams can readily adapt to the changing requirements of your Phase I study, minimising unnecessary delays. The design of complex multiple-part studies (e.g., studies with single- and multiple ascending dose parts and/or food effect parts) can be guided by our professional drug development consultants, and our full-service offering ensure cohesive operations throughout.
If you are planning a Phase I study or would like to know more about any of our drug development services, please contact us.
The hVIVO group’s expertise spans from preclinical to Phase III studies, meaning we can harness emerging Phase I data to provide direction for the next stages in your product’s lifecycle. We allow products to succeed fast or fail fast. This might involve leveraging our expert CMC team to optimise your product, our pharmacokinetic (PK)/pharmacodynamic (PD) specialists to design and analyse bioavailability (BA)/bioequivalence (BE) or drug-drug interaction (DDI) studies, or accelerating proof-of-concept for your vaccine or antiviral at our world-leading human challenge trial and quarantine facility.
We also provide end-to-end regulatory strategy support as well as integrated laboratory, data management, and biostatistics services. The hVIVO group’s recent expansion vastly increased our operational capacity for both inpatient and outpatient studies and we have an established database of over 400,000 participants, both healthy and with diseases spanning several therapeutic areas. Our capabilities will ensure no time is wasted progressing your product from Phase I to the next stages of development.
If you would like to know more about any of our specialist services or our full-service capabilities.
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