At Kerona Scientific, we have vast experience in managing study commissioning and monitoring projects on behalf of clients, from generation of data for full product (Annex III) dossiers, to five batch analysis studies and to generation of alternative and equivalent studies for data matching programmes.
The correct management of study commissioning programmes is vital to ensure timelines are met and the data is of the required quality. Our regulatory team are experienced in commissioning a range of studies in the areas of toxicology, ecotoxicology (aquatic, terrestrial, bee), environmental fate, physical chemical testing, residue and efficacy trials.
We are completely independent of any test facility, ensuring that we obtain the most competitive quotations for studies.
We provide the following services to our clients for study commissioning:
- Selection of test facilities – searches for the most competitive study costs, obtaining quotations from at least 3 test facilities working to meet the client’s budget and timeframe
- Management of study commissioning – setting up the contract, arranging sample shipment with accompanying test item identification sheet, review of draft study plans to ensure it meets study objectives
- Study monitoring once the study is underway – review of progress versus timelines, review of preliminary range finding results and selection of final dose ranges, consideration of results versus validity criteria, review of draft report
If you require assistance with study commissioning, please send an email to info@kerona.ie or contact the team on +353 1 849 5284.