Clinical Research Organization Services and Experience
Develop a clinical hypothesis - We provide a critical analysis of the study hypothesis and develop a primary objective that can effectively address the clinical question.
Protocol Development - LJCVIR will write a clinical protocol that is scientifically sound .
Strategic planning of study - Our planning includes where should the study be conducted, enrolling sites, time frame, eventual presentation and publication.
Development of study associated forms- We will develop promotional and educational materials, IRB documents, case report forms, and informed consent.
Management of study conduct and enrollment- On-line data entry, clinical site visits, formation of a data safety and monitoring board/committee (DSMB) will be managed for your research.
Data analysis - Utilize the expertise of an experienced bio-statistician for accurate sample size estimation and analysis of the study results.
Author the manuscript/abstracts - We will coordinate the publication committee,and direct collaboration of abstract preparation.
Presentation of scientific abstract at national meetings - The information can be presented by an experienced clinical scientist or a presentation can be prepared and assistance provided with preparation.
Press releases - Preparation of a summary appropriate for either the popular or scientific press community.
Our multicenter study experience includes the AVID Trial (800 patients), The Left Main IVUS Registry (250 patients), The STAT Registry (500 patients), and The MagnaSafe Registry (1500 patients). Our role in those physician-initiated trials:
Developed the clinical hypothesis to be tested
Strategic planning of study
Primary author of the study protocol
Authored all study associated forms, IRB
documents, case report forms, and informed consent
Management of study conduct and enrollment
Responsible for data analysis
Chair of the publication committee
Author of the manuscript/abstracts
Presenter of scientific abstract at national meetings