Category Archives: Latest Projects

ECG

Electrocardiography (ECG)

Cardiac Safety – Because healthy and beautiful smiles are for life!

CBCC-vibgyor’s ECG Core Lab is a Mortara Certified Partner providing quantitative analysis of ECGs for cardiovascular and non- cardiovascular drug and device clinical trials. The Director of the ECG Core Lab, Dr. Ajay Naik, is the leading Cardiac Electrophysiologist of India who was trained at the Cedars-Sinai Medical Centre in Los Angeles, U.S.A. (http://www.indianheart.com/)

ECG work flow process

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Technology Advantages

The infrastructure and technology platform at the ECG core lab have the following advantages:

  • E-Scribe Rx Mortara system for receiving centralized-automated clinical data
  • On-screen analysis and interval measurement in FDA compliant XML format
  • Rapid access to annotated ECG data in an XML, CSV, PDFs output format
  • 21 CFR Part 11 compliant systems and resources
  • Audit trail to safeguard operating tasks

ECG Core Lab Services

12 Lead Digital ECG and 12-Lead Holter/3-Lead Holter ECG involve the analysis of the following parameters:

Q-wave identification, ST Segment, T-wave Analysis, Expert QT reporting,QT interval Measurement, Thorough QT studies, Microvolt T-wave alternans.

Biosimilar Product Developments

A biological medicine that is similar to another biological medicine that has already been authorized for use. Biological medicines are medicines that are made by or derived from a biological source, such as a bacterium or yeast. They can consist of relatively small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies. (EMA) The point in favor of biosimilars is the cost advantage.

Clinical studies are required to be conducted on biosimilar to prove its similarity to reference product and absence of any meaningful difference from the reference medicine in terms of quality safety and efficacy.

CBCC- Vibgyor provides strong investigators network for biosimilar clinical trials across India and USA. Reach us to develop the biosimilar and realize the potential of quality, time and cost effective approaches.