Scientific and Medical Expertise

Oncology Trial Imaging

Calyx’s scientific and medical experts have the industry’s most extensive experience in oncology trial imaging, having successfully managed the imaging components of over 1,600 clinical trials across 90 unique oncology indications, including over 75 trials of compounds that were designated breakthrough therapies.

 

Solid Tumor

Calyx’s scientific and medical experts have successfully managed the important imaging components of over 1,300 solid tumor trials – in all phases of clinical development across multiple indications such as cancer of the prostate, breast, bladder, and many more. You can trust Calyx to guide you through the highly nuanced and technically challenging world of clinical trial imaging to ensure your solid tumor development program succeeds. Or if it’s going to fail, to fail fast.

 

Hematology

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.

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.

Learn how Calyx Medical Imaging provided the imaging services needed by a leading pharmaceutical company to support the primary efficacy endpoint of a multiple myeloma trial, delivering critical imaging data in advance of deadlines and helping the sponsor receive accelerated FDA approval.

Neuro-oncology

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

Where to Find Calyx Medical Imaging Scientists

Calyx’s oncology trial imaging specialists routinely participate in industry conference to stay up to date on the imaging trends and regulatory changes that could impact your oncology trial imaging. Click below to meet with them at any of these upcoming events:

Glioblastoma Drug Development Summit

March 26-28 | Boston

 

ASCO

May 31-June 4 | Chicago
Calyx - Global Support and Presence

Library

Improving how we Evaluate Treatment Response in Oncology Research

In February 2022 the Journal for ImmunoTherapy of Cancer published “Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival.” This publication marks the first time immune-related criteria show a correlation with overall survival as the most meaningful endpoint in the treatment of cancer patients.

Calyx Supports Breakthrough Therapy Approvals for Oncology Treatments

Nottingham, UK – Jan. 19, 2021 — Calyx, the eClinical and regulatory solutions and services provider most relied on for solving complex data challenges in clinical research, today announced that its Medical Imaging and other eClinical solutions supported half of the oncology treatments approved by the FDA as Breakthrough Therapies in the past two years.

Advancing 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.

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