Services

KCRI is a full-service clinical research and education organization

explore

Services

KCRI is a full-service clinical research and education organization that serves the Sponsors as a gateway to a comprehensive portfolio of:

Trial design, setup and launch

First In Man studies

Study conduct and monitoring

Safety management

Data management and biostatistics

Data interpretation and expert guidance

Study reports and publications

Core laboratory services

Regulatory affairs and consulting

Data Monitoring Committees (DSMB and CEC)

Key Opinion Leadership expertise

Post-Market Clinical Follow-up (PMCF)

MDR consulting

MDR and ISO 14155:2020 training
regulatory strategy and required conformity
assessment procedures,
pre-clinical research plan
clinical evaluation
PMS program set up
PMCF studies

Medical device manufacturer quality system

ISO 13485: pre-audit, implementation, supplier audit
services in the scope of PRRC – person responsible for regulatory compliance (monthly subscription)

Core Laboratory services

KCRI’s Core Laboratory offers independent, standardized and adjudicated data analysis of several imaging study endpoints:

Echocardiography

Angiography

Optical Coherence Tomography

Near-infrared Spectroscopy Intravascular Ultrasound

Echocardiography is currently used to study the structural analysis of heart disease, heart failure and function of the prosthesis. Image analysis includes measurements of:

Left and right ventricular size (dimensions, areas and volumes),

Left and right atrium size (dimensions, areas, LAVI),

2D LV ejection fraction,

Assessment of LV mass and LV regional wall motions,

Assessment of the diastolic function,

Evaluation of the valves function (velocity, peak and mean gradient, assessment of valve stenosis and regurgitations),

Evaluation of prosthesis function, PPM, prosthesis dysfunction or regurgitation.

Quantitative Coronary Angiography and Quantitative Vascular Analysis.

The analysis of angiographic images include the quantification of the narrowing coronary and peripheral vessel. Qualitative assessment of atherosclerotic plaque at the site of the lesion along with the assessment of the vessel after PCI. This imaging modality provides measurements of:

The dimension of the vessel lumen at the site of the lesion and reference,

The difference between postprocedural and follow-up minimal lumen diameter (late lumen loss),

Assessment of vascular calcification, dissection and thrombosis,

Epicardial flow analysis,

ACC/AHA lesion classification,

OCT is a high-resolution imaging technique of the coronary arteries.

The quantitative OCT includes measurements of:

Lumen and stent/scaffold dimensions, determine of flow area and lumen volume,

Post-procedural asymmetry, expansion, and eccentricity indices,

Post-procedure stent deployment assessment, percentage of stent coverage and neointimal thickness in follow-up,

Qualitative OCT includes assessment of:

Presence of calcified plaque, lipidic plaque and thickness of fibrous cap,

Plaque disruption, thrombosis and stent edge dissection,

IVUS is widely used intravascular imaging modality for assessment morphology and distribution of atherosclerotic plaque. This imaging modality provides measurements of:

Lumen and vessel dimensions, plaque volume and atheroma concentricity (Eccentricity index),

IVUS and NIRS provides information on the distribution of the lipid plaque in the atherosclerotic lesion,

Assessment of stent expansion and stent apposition,

Detection of tissue protrusion,

Identification of mixed plaque with low and high attenuated tissues,

Post-Market Clinical Follow-up (PMCF)

Post-Market Clinical Follow-up (PMCF) is the continuous process of active clinical data collection on the medical device safety and efficacy after market authorization.

PMCF is one of the essential regulatory requirements further emphasized and specified by Medical Device Regulation (MDR).

KCRI will help you collect and use these data for the life cycle management of your device. We developed an efficient and compliant data collection tool to help you in meeting CE (re) certification requirements. It is not only about the data collection, though. Our medical, regulatory, and statistical team will develop the entire PMCF strategy, following state-of-the-art methods and supporting you during the whole process.

Grant activities

KCRI is a recognized
grant recipient

See a complete list of grant activities