Calyx scientific consultants have the industry’s most extensive experience in oncology clinical trial imaging. We’ve successfully managed the imaging components of over 1,500 clinical trials across 90 unique oncology indications. This includes more than 50 pivotal studies – where imaging data supported successful submissions to regulatory agencies – and over 75 trials of compounds that were designated breakthrough therapies.
Calyx’s expert scientific and medical team is experienced in the successful implementation and operationalization of hematology trials, providing solutions to manage complex clinical data and advanced imaging. Our experience includes 300+ hematology trials, including support of 40+ approvals in Lymphoma, CLL, Waldenstorms and Multiple Myeloma.
Calyx has close collaborations with key opinion leaders including Dr. Bruce Cheson, Dr. Joseph Mikhael and Dr. Shaji Kumar, which enables us to address criteria gaps and we work closely with a large pool of board-certified reviewers from renowned institutes with extensive experience in various hematology criteria including Lugano, iwCLL, IMWG, LYRIC, RECIL etc.
You can trust the Calyx Medical Imaging team to provide reliable consultation on hematology trial design, template charters, and applications based on our lessons learned from previous studies incorporating reviewer, KOL, and regulatory feedback.
Calyx provides a wide range of proven imaging services for Neuro-oncology clinical trials. Our network of scientific advisors and in-house expertise allows for full spectrum service offerings to help take your product from discovery to market.
Calyx’s experience in Neuro-oncology imaging includes:
— Primary or metastatic tumor detection/propagation on contrast-enhanced CT & MRI utilizing appropriate criteria and analysis approaches
— Superimposition of sequences to segment out tumor and edema volumes and follow over time
— Advanced MRI analysis per study needs
Innovating the Science
Calyx employs some of the industry’s key thought leaders, including Dr. Oliver Bohnsack who wrote the book on medical imaging in oncology trials – literally. Dr. Bohnsack leverages his knowledge from having co-authored the immune-related response criteria (irRC, 2009), served as first author of irRECIST (2014), and co-authored Comparison of Assessments using RECIST and irRECIST by Manitz J. et al. (2020) as he designs and implements optimal imaging strategies for Calyx’s customers developing new oncology treatments.
And Calyx’s Dr. Manish Sharma understands the importance of quality imaging reads and the value of trained, effective readers. He developed multi-dimensional, real-time monitoring metrics to improve reader performance assessment, which is available for every study we undertake to ultimately improve the quality and integrity of your important clinical trial data.
Calyx’s Medical Imaging team leverages our established operational footprint to implement an imaging strategy that acquires complex yet optimized CNS images from investigative sites around the world.
With local support in India, China, North America, and Europe, you can have confidence that the imaging components of your CNS trial will run smoothly and deliver high quality data you can rely on. Every time.
Discover Our Therapeutic Expertise
Calyx’s expertise spans across all phases of clinical development and therapeutic areas. In addition to CNS, we have significant experience and proven capabilities in providing medical imaging services to support the clinical development of new treatments in oncology, musculoskeletal, and many other therapeutic areas.