Project Management and Core Lab documents Development
The Core Lab at CBCC-Vibgyor has an impressive project management team with a proven track record for your medical imaging requirements in clinical trials. Quality, speed, and results with an in-depth knowledge and expertise in most imaging modalities backed by a team of experienced cardiologists helps us commit to services that go above and beyond the expected thereby increasing our Sponsor’s confidence and trust in our work.
The skilled and experienced Project management team offers the following capabilities
- Client servicing for Sponsors
- Site assessment, selection, training, approval, and management for Core Lab
- Review of clinical trial protocols to provide expertise with regards to imaging requirements
- Preparation of Site Procedure Manuals and Image acquisition protocols
- Developing and presenting Core Lab presentations at Investigator meetings
- Designing Data Transmittal Forms, Imaging charters, Review Checklists, and Project-specific documents
- Developing study-specific Standard Operating Procedures (SOPs), if required
- Review and finalization of databases for final submissions
- Ensuring smooth working and completion of all core lab activities throughout the Project Life Cycle
Site Management and training is one of the crucial aspects in clinical trials involving imaging. At CBCC-Vibgyor Core Lab, site management begins with the selection of qualified sites and Investigators by assessment of onsite equipment, systems, and softwares; determining experience and qualification of site staff; reviewing test studies or qualifying data; providing detailed recommendations for improvement; and providing site approvals. The dedicated Project Management team at CBCC-Vibgyor Core Lab develops training materials to ensure all sites are trained appropriately on image acquisition and transmission procedures. The PM also participates in Investigator Meetings for presenting Core Lab presentations and provides onsite training for complex protocols. The team of Project Managers and Cardiologists is available 24/7 for timely query resolution support services to the site.
Once the images have been captured, they are transmitted to the Core Lab accompanied by a valid and completed Data transmittal Form (DTF). On receiving the study at the Core Lab, all data is run through a quality check to ensure that all variables are within pre-determined guidelines. Once data has been verified, the images are analyzed at 2/3 levels by adhering to protocol requirements, Core Lab guidelines, and SOPs. A template database is developed according to Sponsor requirements to define the analysis parameters to be incorporated in the final database. The final database that is generated undergoes 2 levels of quality checks and is made available to the Sponsor on completion or on interim basis. A tracking system can outline the status of every study received and analyzed by the Core Lab. The team designs and maintains a comprehensive list of logs and spreadsheets to track study progress, incoming image data, patient enrollment, and outstanding patient data. We proactively perform regular data backup. Role-based access control facilities are available to protect project data. The Core Lab has experienced 100% percent success rate in external ISO audits. The Data Managers and Project Managers are always available to provide customized data management or support services to the Site and Sponsors.
CBCC-Vibgyor Core Lab offers the necessary operational and technological infrastructure as well as support services required for the acquisition and transmission of images.
Our proven systems and processes enable acquisition of high-quality images. We offer the following capabilities:
- Test data capture and analysis, followed by recommendations for improvement
- Design and development of standardized image acquisition protocols as well as Site Operating Manuals
- Centralized image collection and archival
- Proactive image tracking and reminder notifications
The site may transmit the images and accompanying DTFs either electronically or via courier. Images transmitted electronically are saved on the Core Lab server with a unique ID under each patient folder for all sites of a designated project. All CDs/DVDs received via courier are labeled with a unique identification number and logged into the system upon arrival. A fax or an email confirming receipt of each study is generated and sent to the clinical site upon receipt of the study at the Core Lab.
Analog to digital conversion
The Core Lab is capable of receiving image data in any virtually or commercially available formats including DVDs and CDs.Received are digitized and images are saved in DICOM or avi file formats.
Web transmission services
The Core Labs offers web-based digital transmission of imaging studies. Studies can be submitted from any desktop computer to the Core Lab with internet access via a secure web-site. All studies are then electronically archived on a secure server and are available for immediate review. This minimizes the logistic strain and cost of couriering images.
Once the images and the accompanying DTFs are received at the Core Lab, they are reviewed for the predetermined protocol parameters. If any query has risen during review, a Core Lab Quality Report (CLQR) is generated and sent to the site for resolution. On resolving the CLQR, the study is analyzed in a blinded fashion by skilled and trained technicians followed by its review and finalization by a board-certified cardiologist. The Core Lab generates standardized data that is accurate and reproducible.
Image archival and Storage
Images serve as the source documentation for analysis, and at CBCC-Vibgyor Core labs, all images are stored and archived on completion of analysis. CDs/DVDs can be archived at the Core Lab for the duration of the study and long-term, if desired. All images received electronically are copied to a secure server and are stored digitally with regular backup.