End to End Medical Imaging Solutions

products-servicessyneed medidata GmbH
December 17th 2012

syneed imaging, the department of syneed medidata that focuses on imaging services, provides end-to-end medical imaging solutions for phase I-IV clinical studies to meet all your needs. We offer imaging services and solutions from study planning, protocol development over image collection and quality control to the organisation and conduct of central image reviews.

Our medical expertise and our innovative software development capabilities allow us to excel and offer complete medical imaging solutions.

Our services include:

Study Planning and Set-Up
• Consultation on imaging study protocol and endpoints
• Site Qualification and training of site staff and monitors
• Development of study specific Image Acquisition Guideline, Imaging Site Manual and Central Review Charter

Conduct
• Image Collection (web-based electronic transfer), Data Tracking and Storage
• Site communication and query management
• Image Quality Check and Processing for Central Review
• Central Reader Selection and Training
• Technical Setup of Central Image Review in house or remote
• Web-based Reporting of Study Progress
• Parameter Imaging and functional Analysis
• Pre-clinical Imaging Services

Central Review
• Technical Setup of Central Image Review in house or remote
• Central Reviewer/Reader Selection, Management, Training and Quality Monitoring
• Wide Reader network with sub-specialized, board certified radiologists
• Conduct of Independent, Central Review
• Data Reconciliation, Management and Statistical Analysis
• Review DataExport and Archiving
• DICOM viewer with integrated eCRF analysis
• Implemented Audit Trail
• GCP and 21 CFR Part 11 compliant
• Wide variety of assessment criteria covered: RECIST 1.0 and 1.1, WHO, mRECIST HCC, Choi, Cheson, irRC, RANO, PERCIST

For more information or to discuss end to end medical imaging solutions please contact us directly.