Clinical validation for Serologic Corona virus (COVID-19) diagnostic test kit
Use of Corona (COVID-19) virus diagnostic test kits (IVDs) requires registration with the Ministry of Health.
NEW!! The Ministry of Health has recently imposed the requirement for Special Clinical Trial for Validation of Serologic, IgG/ IgM based, Fast result Corona tests / kits.
Sponsors must perfom and provide a clinical validation trial result to validate the corona diagnostic kit. Measures for compliance and approval.
It is a mandatory requirement in order to obtain a license.
The trial need to comply with WHO guidelines and perform cross-reactivity testing as well.
Mind Pharma Europe can provide guidance, support and process such validations of Fast Serology Corona kits.
We, at Mind Pharma Europe consult, assess the documentation of Sponsor’s kit, its avialable data (clinical, publications, science..), certifications (CE, ISO, licenses etc) etc. Our team provides guidance and consultation on such trial design and can lead its execution.
We assemble the Corona Special Clinical Trial application dossier process submission to IRB / Helsinki committee approval and escort till completion with a study results report.
Our support extends beyond registration of Corona diagnostic kit!
Need more information? Need to process a Special Corona Clinical trial? Contact us here.
Mind Pharma, managed by Shavit Fragman provides Appointed Pharmacist , Responsible Pharmacist – Qualified Person (QP) & batch release , Qualified Person Pharmacovigilance (QP-PV) and Medical Director services.
We also support establishing quality assurance system management, writing SOPs, audits, mock audits, quality and technical agreements.