CLINICAL RESEARCH SUPPORT
Navigating the complexities of clinical research is daunting, and at Healios we recognize this. Our goal is to provide streamlined solutions to provide robust and actionable clinical data. All in all, here are how we can improve your efforts at research.
Bioavailability and Bioequivalence Trials for Generics
In a generics competitive landscape, bioequivalence has to be established. The Bioavailability (BA) and Bioequivalence (BE) trials performed are meticulously designed and comply to the most stringent regulatory frameworks as well as FDA and EMA. We optimize pharmacokinetic studies which elucidate the relative bioavailability of your formulations to expedite pathway to market entry.
In-Patient Bioequivalence Trials for Complex Generics and 505(b)(2) products
Advanced methodologies are used for our in-patient BE trials in complex generics and in 505(b)(2) submissions to ascertain therapeutic equivalence. Drawing on a multidisciplinary team, we meticulously design and conduct these trials using well chosen endpoints and statistical rigor to ensure the integrity and reliability of the data. This allows you to tackle regulatory hurdles confident in the knowledge you have followed a proper proven path.
Bioanalytical Services for Precise Data
Our bioanalytical services enable our clients to increase the reliability of their clinical studies. With our state-of-the-art technologies such as LC-MS/MS and HPLC, we analyze your samples using rigorous sample analysis and method development optimized to your particular need. Never have to question the reliability of your data points again; our commitment to GLP compliance gives you the insight you need to make good decisions based on reliable data, each and every time.
Are you prepared to elevate your clinical research capabilities? Partner with Healios, where expert support transforms complex challenges into reliable data and successful outcomes. Together, we can advance your research objectives with precision and scientific excellence.