Services


Services


Our services cover the imaging part of clinical studies in all therapeutic and diagnostic areas. We can offer cost-effective and flexible solutions ranging from simple image data handling tasks to global multi-modality multicentre trials. All our systems are validated (510k, GCP) and operate according to relevant regulations (GCP, HIPAA, 21 CFR part 11 etc.) and all services provided are GCP compliant. With more than 19 years experience we have built an effective organization with modular tools, systems and processes suitable for imaging studies of any size or modality.


Quality Assurance / Technical Support


We offer technical support during the site setup process.After collecting the images we perform ongoing technical quality assurance such as correctness and completeness checks, conversion and standardization of images, evaluation of diagnostic quality. We provide electronic audit trails for all image data.


We provide Image Tracking Database and/or Image QC Database. All our procedures are covered by validated Standard Operating Procedures..


Designing the Independent Review Charter


We review protocols and give advice as to which type of measurements/evaluations can be performed and what type of equipment/software is needed to meet the endpoints. We also prepare the Independent Review Charter based on the Sponsors Clinical Study Protocol..


Image Data Management


We offer comprehensive image management throughout the study. This includes transfer, storage and archiving of images/study material. All our services are HIPAA and FDA 21 CFR Part 11 compliant on validated eqipment/workstations.


Prepare and facilitate blinded reads


Conversion of the DICOM header, blinding and randomization of images. Provide a GCP environment for blinded reads. We also offer technical support during the blinded reads and provide training in optimal use of our workstations.