CBCC-Vibgyor’s Core Laboratory is an ISO 9001:2008 certified Medical Imaging Laboratory specializing in the independent analysis of Phase I-IV Drug and Device clinical trials around the world. Comporting as a catalyst in the drug and device design process, the Core Lab provides expert, objective, accurate, timely review and analysis of pre-specified, study-related variables.
The Core Lab team comprises board-certified cardiologists, technicians, analysts, data assistants, and system engineers having vast experience with trial design, data interpretation and analysis, global study management, and regulatory strategy consultation.
Our balanced and diversified service portfolio includes independent analysis, evaluations, and assessment of the following cardiovascular modalities:
- Electrocardiogram (ECG)
- Echocardiography (ECHO)
- Quantitative and Qualitative Coronary Angiography (QCA)
- Quantitative and Qualitative Peripheral Angiography (QVA)
- Computed Tomography Angiography (CTA)
- Intravascular Ultrasound (IVUS)
At the Core Lab, review, reading, and analysis of images is performed either at 3-levels (ECG) or 2 levels (ECHO/QCA/QVA/CTA/IVUS) in a structured and blinded fashion: Preliminary review by a Physician or a trained and experienced Technician and final analysis by Senior Cardiologists. With an ISO 9001:2008 certified Core Lab comprising skilled project managers and technicians with vast experience and deep expertise; we aim to offer the highest level of service to complete your project on time and on budget. In an environment that demands rigorous assessment at each stage of drug/device development, We simplify the entire process by flawless management of complex trials across various sites in multiple countries.
We have the expertise to get it right and the resources to make it simple! We give your clinical development program a yardstick of quality by providing access to clean, reliable, and comparable data that is accurate, consistent, and reproducible. Our quality standards are marked by periodic Inter-Intra observer variability assessments as well as Internal and External Audits. We try to exceed expectations by adhering to a dedicated timeline for reviewing and analyzing each image and interpreting each ECG. Analysis is performed by highly experienced personnel with meticulous adherence to Core Lab Standard Operating Procedures; compliance to all regulatory and applicable guidelines including US FDA/EMEA, 21 CFR Part 11, ICH E14 and standard performance metrics.
The CBCC-Vibgyor Advantage
We are your healthcare partners providing cost-effective solutions that are tailor-made for your specific needs. Our comprehensive Core Lab service portfolio comprises site selection,assessment and evaluation of onsite equipment, quality management for the validation and assessment of the reliability and integrity of data, and availability of 24/7 cardiologist expertise as well as site support services with efficient turnaround time for query resolution. The technical team coupled with the project management team at the Core Lab is highly proficient with a proven track record in core laboratory services giving CBCC-Vibgyo Core Lab the unparalleled advantage.