Pre-feasibility and feasibility studies

When tasked with assessing its sites’ recruitment potential and deliverables, Cardiorus’ proprietary search algorithm assesses each registered patient and runs a simulation on how the proposed inclusion/exclusion criteria and end points would affect study recruitment and conduct and provides accurate pre-feasibility and feasibility reports to sponsoring organizations.

Regulatory support

Cardiorus provides full regulatory support, including consultations with regulatory authorities, preparation and submission of study dossiers to the Ministry of Health and to the Central Ethics Committee.

Local Ethics Committee (LEC) approvals

A single on-site LEC grants approvals to initiate the studies and Cardiorus works closely with the LEC on addressing any questions that may arise during the review process

Patient recruitment and retention in phase I-IV studies

Active recruitment via conventional and social media as well as frequent communications with the investigators and weekly study progress tracking assure robust and on-target patient accrual. Cardiorus patient notification and enrollment correction strategies assure exceptional retention while minimizing drop-outs rates

Administrative support for study conduct

Cardiorus acts as a single point of contact for both the sponsor and the investigator and is in charge of contract negotiations, investigator and site payments

IT support for EDC, IVRS and CTMS

All technical support is provided by Cardiorus’ IT staff that is available 24 hours a day, 7 days a week

Clinical trial supply, warehousing and logistics

Cardiorus’ specialized central depot and logistics group takes care of IP/CTM importation, storage and distribution to the sites as well as of local comparator and trial material procurement

Project management

Cardiorus’ experienced Project Managers (PMs) offer comprehensive strategic solutions to its sponsors. Our PMs closely oversee sight management and are ready to handle the whole spectrum of trial-related activities, from site initiation to database lock.

Commercialization, post-marketing studies and registries

Given its tremendous patient coverage, Cardiorus is a perfect location for conducting of post-approval and observational studies. Having all patient data in one EMR system allows for rapid patient matching and enrollment. Cardiorus’ staff is very familiar with local drug registration requirements and is capable of designing and running registration trials that are required for local new drug applications