Phase I/Bioequivalence Studies

Phase I/Bioequivalence Studies

Accord Research has extensive experience in designing and conducting phase I studies and offers a full range of services to Sponsors. As part of this offering, we cooperate with international experts on bioequivalence (BE) / bioavailable (BA) studies, who participate in the development of the study design, protocol writing, determination of Pharmacokinetics (PK) sampling, and analysis.

We also collaborate with specialist units experienced in BE / BA phase I studies in the Czech Republic and can contract bioanalytical laboratory and logistics for samples shipment as required.

In 2009 members of the Accord Research management team co-founded a phase I unit located in the University teaching hospital in Prague, the Clinical Pharmacology Unit (CPU), and has exclusive cooperation with this facility. The CPU has 28 beds and specialises in conducting early phase studies, including the first human study in a range of special patient populations e.g. oncology, hepatic insufficiency, renal insufficiency.  The CPU has a team of qualified investigators and research nurses as well as access to full emergency care within the hospital facility. The unit is being regularly inspected by SUKL, the Czech Regulatory authority, and has also achieved ISO certification 9001/2008 (2010).