Primary and secondary prevention studies

May 15, 2012 Organization Services

CRO P_1000_398

 

 

 

 

 

 

Cardio Vascular Trials & Registries

 

Overview:
ISPHA CRO is a Contract Research organization (CRO) that provides a range of services for clinical trials and other research projects.
With over 20 years experience, ISPHA and its Coordinating Center, have the tools and experience to readily produce results.
Participating hospitals maintain affiliations with leading university medical schools and benefit from their location in Israel, a world-leading center of medical, scientific and technological research that has gained an international reputation for excellence.

Internationally Recognized Experts
The scientific and steering committee members of the research projects include internationally recognized experts such as the directors of cardiology departments in Israel, who are all affiliated with major institutions of higher education, including the Tel Aviv University, The Technion – Israel Institute of Technology, The Hebrew University of Jerusalem, and the Ben-Gurion University of the Negev.
From Protocol to Publication
ISPHA’s CRO is one of a few centers that can steer you through design and performance of the study, through data collection, editing, final analysis and publication.

The services provided by our facility include:

  1. Compiling complex study protocols and preparing case report forms
  2. Full range of clinical investigation activities
  3. Central laboratory organization for uniformity
  4. Full scope of data management activities including: quality data entry through tailored interfaces with extensive logical checks and data validation to enhance error-free data entry
  5. Monitoring and off-line quality assurance process
  6. Automated data transfer from and to laboratories, participating centers etc.
  7. Statistical analysis and consultation
  8. Scientific writing group with extensive experience in medical writing and publication in the scientific literature.

Study management / coordination
ISPHAs experienced team will accompany you from the first steps of the project to its successful conclusion.
Our study management team and coordinating center will help you in:

  1. Planning and initiating research projects
  2. Preparing the study protocol
  3. Research site liaison
  4. Budget management
  5. Progress and status reports
  6. Tracking CRFs and DCFs
  7. Medical monitoring and reporting of Serious Adverse Events

Data management
ISPHAs academic CRO is known for its extensive experience in quality data management. Our data management staff includes data base administrators, data managers, a quality assurance officer, SAS programmers, and data entry operators also trained as medical secretaries with a thorough knowledge of medical procedures and terminology.
Data entry is done through tailored data entry interfaces that include on-line quality assurance checks.

Our services include:

  1. CRF Design and Production
  2. Patient and CRF tracking system
  3. Database setup
  4. Data Dictionary Implementation including automatic and manual coding by coding experts
  5. Data Entry by trained data entry operators
  6. Automatic Data Audit Trial
  7. Data quality assurance:
    - lausibility Checks
    - Query Development
    - Query resolution tracking