ECG Data Centralization

 

Clinical Consulting is a provider of centralized diagnostic services for clinical trials. Clinical Consulting  is specialized in the centralization of cardiac safety and efficacy diagnostic data for pharmaceutical and medical device clinical trials.

Clinical Consulting offers a cardiac diagnostic systems including:

  • Digital 12-Lead ECG 

  • Holter Monitoring

  • Ambulatory Blood Pressure Monitoring 

  • Echocardiography

Clinical Consulting can offer services and support 24 hours a day, 7 days a week, 365 days a year.

Clinical Consulting system has set the health care industry standard by providing innovative approaches to non-invasive diagnostic services, clinical trials, and products. We provide our clients with the ability to increase cost efficiencies and bring studies to database lock on an advanced.

We continue to invest in advanced technologies to meet the ever-changing needs of our clients.

Clinical Trials

ECGs are often taken to confirm inclusion criteria for clinical trials, to determine end points, to assess any long term risks and provide a form of non-invasive assessment that is vital to many clinical trials. Centralization and interpretation, storage and retrieval of ECGs has several advantages:

  • Centralization of ECG reporting in a core lab permits secure central interpretation, storage and retrieval of ECGs used in clinical trials. Centralization also helps to make communication a simpler, speedier and more efficient process.

  • Accuracy of results can be improved. Studies have shown that visual analysis of ECGs by physicians or other qualified individuals can result in wide variations in interpretation and can lead to false positive and negative results. Computerized interpretation and restriction of visual interpretation to a small number of highly trained individuals adhering to strict operating procedures, reduces these types of errors and increases reproducibility and accuracy of results.

  • Retrieval of data. Centrally located databases provide a secure and easily managed source for ECG storage and retrieval.

Excellence of ECG processing ensures that clinical trial data is processed to the highest possible standards.

Clinical Consulting Systems offers a variety of equipment options allowing us to be efficient and flexible in meeting our sponsors’ requests.

Clinical Consulting service offerings with our international, experienced project and data management teams have earned us a solid reputation for Europe wide reliability in the centralization of data for clinical trials.

 

Clinical Consulting Methodology

Centralization of data provides a more efficient way to acquire, analyze, and manage data collected at clinical sites.

Clinical Consulting methods have improved data accuracy, shortened timeframes, and lowered costs for our clients. Our management team continually evaluates, refines, and improves the implementation of our processes and technology as regulatory issues evolve and technology advances. Clinical Consulting system’s  goal is to remain the clinical trial leader by continually monitoring our clients’ needs and developing innovative solutions that contribute to their success.

Clinical Consulting Systems’ proven methodology centers upon minimizing variability by dedicating a cardiologist over-reader and standardized equipment and processes.

  • Dedicated Cardiologist
    Certified, sub-specialty medical experts in cardiology reduces variability associated with the reading of measurements and interpretations of the diagnostic data.

  • Standardized Equipment
    Wide range of equipment options to fit specific needs of protocol. Same make and model equipment distributed to all clinical study sites increases consistency and efficiency in training reduces data discrepancy.

  • Standardized Processes
    Standard Operating Procedures (SOPs) for European receiving center ensures data collected internationally processed identically supports protocol requirements.

ECG Devices

 

AsCARD MrGrey (EKG-M@IL)

Best in class, AsCARD MrGrey electrocardiograph with additional option of sending ECG examinations through e-mail directly from device. Moreover,  the apparatus enabling a 3/6/12 chanel printout on 112mm-wide paper, automatic analysis and interpretation as well as INOP control.

 

Certificates - ASPEL

ASPEL JSC has been in medical market since 1986. Main activity is manufacturing of electronic  medical equipment, dedicated for cardiology. The growing requirements of our customers stimulate the technical development of our company. In order to satisfy their needs existing products are modernized and new ones are introduced.  We put strong emphasis on quality and safety of our equipment. The scientific-technical potential, achieved mechanical and electronic back-up facilities and research laboratory guarantee the high quality.