Sannova has worked on Bioequivalence (BE) projects with clinical organizations around the world, having analyzed samples from the US, Canada, India, Eastern Europe and Western Europe as well.
With its signature “Z factor” approach, Sannova reduces the overall variability in BE studies by reporting the true values for concentration of analytes in clinical trials. At Sannova, the variability associated with bioanalysis is reduced to an absolute minimum. Thus Sannova’s clients in the generic and 505 (b) (2) space have enjoyed a very high success rate when utilizing data generated by Sannova.
Sannova is especially well known for its success in “first to file” bioequivalence studies. Since the essential factor in these projects is time, Sannova maintains continuous logistics with careful planning and preparation. In this way, the time from the first dose to the final bioanalytical report can be minimized without causing any compromise to the high quality standards on which ANDA approvals depend.
Sannova works with with clinical CROs as either subcontractors, or as independent contractors, and will help identify a clinical CRO for the sponsor if they have not already identified one. Seamless project management at Sannova assures the feel of “one stop” shopping where multiple partners are involved. In all cases, Sannova works diligently with all parties to be sure that the maximal probability of success is realized.
Working from a 21,000 square foot facility, with a capacity of 360,000 samples per year, Sannova has the ability to focus its teams to set the highest standards for timelines and quality.
Please contact Sannova to learn more about the ways that Sannova can assist with your BE needs.
Sannova has worked with clinical organizations around the world, having analyzed samples from the US, Canada, India, Eastern Europe and Western Europe as well.
Sannova utilizes three different business models with clinical CROs:
1) The Sponsor comes to Sannova with a clinical CRO already identified and contracted, and simply asks Sannova to provide its world class bioanalytical services to analyze the samples generated.
2) The sponsor asks Sannova to advise on a clinic offering the best possible recruiting capability, access to special populations, or therapeutic expertise as the case may be, with the sponsor then setting up an independent relationship with the clinical CRO.
3) Sannova takes full responsibility for the entire study, and subcontracts the clinical portion of the study for the sponsor in a “turnkey” arrangement.
Sannova is willing to work in all of these settings, as dictated by the sponsor’s requirements and needs.