We have been working with the MGH Department of Radiology for over 18 years and bring a wealth of expertise in executing WHO, RECIST (1.0 + 1.1) and CHESON review criteria. Extensive experience in complex, multi-component trials allows us to simplify our sponsors’ review process and deliver workflow flexibility unlike anyone else in the industry.
Examples of Oncology Expertise
EACs in Oncology Trials
As Endpoint Assessment Committee (EAC) review becomes increasingly important to oncology trials, the resulting study workflows are growing more complex for sponsors. WCC’s advanced project management and trial workflow expertise enables the integration of not only the imaging data of an oncology study, but additional clinical components such as pathology and dermatology reviews for complete subject assessment.
And because our WorldPRO technology system offers sponsors real-time views of the study data over the course of the entire trial, they can confirm the upload and accuracy of all data before final EAC review. This transparency – facilitated by WCC’s advanced workflow design – helps prevent against EAC re-reads that put your data in jeopardy. We work to ensure that all EAC assessments are as complete as possible and can withstand full scrutiny of regulatory review. With WCC, sponsors can expect secure image submissions, total study transparency, and a detailed audit trail. With varying requirements for different oncology studies, WCC provides a flexible framework that is tailored to each sponsor’s specific needs to reach FDA review with confidence in the submission.
September 21, 2011
© 2012 WorldCare Clinical
