How Cisiv helped accelerate a Medical Diagnostic Validation study to obtain regulatory clearance
Cisiv partnered with a specialist CRO and a Medical Device Company (IVD Sponsor) to conduct an end-to-end process for clinical evaluation of an In Vitro Diagnostic (IVD) classed as a Rapid Diagnostic Test (RDT). This enabled the IVD Sponsor to obtain Emergency Use Authorization (EUA) during the Covid19 pandemic in an exceptionally short time frame.
Delivering vital therapies to patients through Expanded Access Programs
Designing a data capture tool for a multi-national Expanded Access Program to manage a CRO’s use of their biotechnology customer’s new product for critically ill COVID-19 patients.
Empowering a CRO with data capture and eConsent tools for a suite of pregnancy registry studies.
Designing and Conducting a successful Healthcare Effectiveness and Outcomes Research study
Creating a successful Healthcare Effectiveness and Outcomes Research study with benefits for both sponsor and sites.
Real world studies in complex treatments
Oncology real world studies: fit for purpose technology and process. How the flexible structure of Cisiv’s EDC platform, Baseline Plus, is well suited to oncology studies and helped support the complex patient lifecyle of this leading Biopharma company's oncology study.
Baseline Plus - ideally suited for orphan drug and post approval research
Creating simple, intuitive and cost-effective solutions to the management of data from a large number of sites. How Baseline Plus provided the ideal platform to enable a specialised European Pharma company to run a post approval safety study as a licensing requirement.