Calyx is a leading provider of proven medical imaging services with extensive experience in musculoskeletal (MSK) imaging endpoint assessments. When tackling the many challenges involved in MSK trial imaging, global clinical trial sponsors repeatedly turn to Calyx for the right experience, people, processes, and technology to drive their MSK development program’s success.
Having supported over 360 MSK trials to date, many of which have led to regulatory approvals, Calyx Medical Imaging is uniquely positioned to deliver reliable imaging data to demonstrate the safety and efficacy of your compounds in development.
By working with Calyx, you have access to experienced scientists and medical professionals who are experts in MSK imaging endpoints and criteria and are up to date on current, global regulations. They deliver technical expertise in the imaging modalities most often used in MSK trials, in protocol design, and in standardizing image acquisition across global investigative sites.
Calyx’s expertise spans the entire spectrum of MSK disorders. Click below to learn about Calyx’s experience in these indications:
In contrast, non-radiographic axial spondyloarthritis (nr-AxSpA) does not display conclusive evidence of damage in the sacroiliac joints when examined through plain x-rays, unlike ankylosing spondylitis (AS). Instead, the presence of damage can only be visualized using MRI.
Calyx brings extensive expertise in managing clinical trials within this field, having supported over 20 Ankylosing Spondylitis trials to date. Our team collaborates with renowned global experts who serve as central readers for these trials, ensuring the highest level of precision and accuracy.
Click here to see research presented by Calyx scientists at recent ACR conferences.
Some of the criteria/assessments we have supported for Axial Spondyloarthritis trials are:
X-ray is sometimes used for eligibility by confirming presence of bone erosions or juxta-articular bone formation (in support of deriving a CASPAR score for PsA). X-rays of joints in the hands and feet are used to derive scores for various criteria such as modified Van der Heijde Sharp (mTSS) scores and other variations as needed to support efficacy endpoints.
MRI imaging is used to support Rheumatoid Arthritis MRI scoring (RAMRIS), Psoriatic Arthritis MRI scoring (PsAMRIS) and also in quantification of Rheumatoid Arthritis using MRI (RAMRIQ). In order to ensure consistency in positioning and image quality specialized hand positioners and templates are used. Additionally, MRI and ultrasound imaging (US) are employed to support inflammation in the joints such as in tenosynovitis etc.
Calyx has supported the medical imaging needs of over 60 RA and PsA clinical trials to date, including the use of the following criteria/assessments:
Calyx had supported the medical imaging needs of over 35 osteoarthritis trials and understands the specific needs of these trials. For example, we provide special knee, hip, and hand positioners to sites and train the technicians to acquire the appropriate views and angles especially since Joint Space Width (JSW) is highly sensitive to the technique employed. MRI imaging in OA also requires dedicated protocol implementation on scanners and working closely with sites to provide timely feedback to optimize image quality.
Some of the criteria/assessments we have supported for Osteoarthritis trials are:
Dual-energy X-ray Absorptiometry (DXA) and X-ray imaging are routinely supported to assess efficacy and safety endpoints as well as support eligibility criteria. Our staff has extensive experience with Osteoporosis research/imaging, and we consult closely with clients to provide feedback on DXA and X-ray-related endpoints and safety signals during protocol development or revisions to ensure these are adequately captured. We also have a network of KOLs we can leverage to advise clients as needed.
DXA-derived T-scores as well as vertebral fracture assessments are reported to sites to enable timely decisions. Intelligent eCRF design and automated results reporting as per the unique requirements for each trial are put in place to ensure efficiency. In addition, our team also provides support to address site-central discordance and works closely with sponsors and sites to resolve such issues. Our solutions deployment and scientific staff work closely with the sponsor teams both to ensure the appropriate parameters and readouts are captured in the data exports and appropriate exports are designed to support any regulatory submissions.
Some of the criteria/assessments we have supported for Osteoporosis trials are:
An X-ray of the hand and wrist are acquired and assessed by comparing it to the Greulich and Pyle Atlas. At Calyx, we have extensive expertise in this field and a knowledgeable team of readers. Additionally, we have the advantage of utilizing automated bone age assessment software (BoneXpert) based on the requirements of the trial.
Some of the criteria/assessments we have supported for Bone Age trials are:
Our team is well-versed in the field of Gout, and we have the privilege of collaborating with Gout Key Opinion Leaders (KOLs) including Massachusetts General Hospital (MGH), who are renowned for their expertise in DECT analysis for Gout. Both our in-house experts and the KOLs are available for additional guidance to our clients as necessary.
We have worked with various modalities including DXA, CT, and MRI to delineate changes in these various anatomical locations. We can work on intra-muscular fat assessments using MRI sequences as appropriate and partner with third-party vendors on a need basis to facilitate the successful implementation of the right protocols and derive endpoints. We have dedicated expertise in-house to tailor sequences to achieve the desired outcomes in a standardized fashion which included direct communication with sites during initial protocol setup and robust QC to provide feedback.
Calyx has experience in supporting various pediatric and adult rare indications affecting the musculoskeletal system such as Gaucher’s disease, Osteogenesis Imperfecta, Pompe disease, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy (SMA), Achondroplasia and Fibrodysplasia Ossificans Progressive (FOP). We work closely with the client and expert readers/ KOLs to define the endpoints and design appropriate eCRFs to capture efficacy and safety endpoints to support decisions employing various modalities including but not restricted to X-ray, US, MRI, DXA, CT etc.
We tailor the image acquisition guidelines to ensure adequate coverage and appropriate views and implementation of scanning protocols. Toward this end, our experienced technical staff work closely with the sites to review protocol implementation, phantom scan acquisitions as appropriate, and tailored training. Given the nature of rare diseases and the unique image assessments involved, Calyx is well positioned to provide guidance as well as work closely with relevant experts from the field as needed.
Some of the criteria/assessments we have supported for Rare Disease trials are:
By working with Calyx, you have access to some of the industry’s most experienced MSK imaging experts. Our in-house medical imaging experts, including MDs, PhDs, imaging technologists, imaging physicists, and a dedicated exploratory imaging group are equipped and well-positioned to help you gain the information needed from new and novel imaging methods.
We collaborate with you to identify the most reliable readers and optimal read model for your trial, balancing their read volumes, and ensuring low inter-reader variability to drive the highest quality imaging reads for your study.
Our flexibility in choosing MSK-experienced readers enables you to utilize virtually any KOL as an expert reader including:
Prof. Jürgen Braun (Germany)
Dr. Kay-Geert Hermann (Germany)
Prof. Robert Landewe (Netherlands)
Prof. Désirée van der Heijde (Netherlands)
Dr. Charles Peterfy (USA)
Dr. William Palmer (USA)
Expert team at Massachusetts General Hospital
Calyx Medical Imaging delivers expertise in the significant majority of imaging modalities used to support the development of MSK-related treatments, including:
Calyx is well versed with the requirements and techniques / views needed for such assessments. Calyx authors succinct and site/technologist friendly guidelines to allow for consistent and robust imaging which outlines the views and technical parameters such as KvP, collimation as well as the use of templates for consistent positioning etc.
Calyx works closely with sites to implement the most appropriate protocols on MRI scanners at the sites as well as clearly outline requirements in the Image Acquisition Guidelines (IAGs). Our in-house MRI experts provide training and feedback to sites based on either phantom imaging or first subject scan quality to ensure appropriate scanning and quality.
Calyx also works closely with 3rd party vendors and KOL collaborators to derive quantitative CT measures in various skeletal abnormalities including assessment of volumetric BMD and estimation of bone strength and cortical and trabecular microarchitecture. We partner with ON Diagnostics to provide finite element analysis especially relevant for bone anabolic therapeutic drug candidates. We also partner with KOLs and academic labs to help obtain specialized and niche assessments such as trabecular and cortical architecture such as trabecular thickness and umbers and cortical thinning and porosity which yield critical information on short or long-term drug safety effects.
Body composition changes such as in bone, lean, or fat mass are also monitored by DXA in indications such as obesity, diabetes, HIV, etc.
Calyx has extensive experience in supporting all phases of global and region-specific DXA trials and we work closely with the clients and partners /sites to ensure that the appropriate imaging guidelines are adhered to and critical steps are done in a timely fashion such as Instrument quality control.
Calyx also partners with a third party vendor to provide TBS scores for trials looking at indices of bone quality. Calyx’s experienced operational and scientific team closely engages with the client from the start of the trial to identify appropriate scanners, determine adequate training for technologists at sites and provide timely feedback on image quality.
Given the complexity and required precision of MSK ultrasound imaging, Calyx strongly recommends that images be obtained only by sonographers and physicians with significant MSK scanning experience.
Calyx’s operational model enables our client delivery teams to anticipate your study needs and scale our services to deliver quick and reliable continuity of service with efficient setup of sites, dedicated teams for QC support, and reduced imaging queries to meet your trial timelines.
With deep operational oversight delivered through MSK trial-experienced project managers, Calyx Medical Imaging delivers the flexibility and scalability trial sponsors need during all stages of MSK treatment development, helping them to overcome challenges and confidently tackle unexpected trial changes.
With local support in India, China, North America, and Europe, you can have confidence that the imaging components of your MSK trial will run smoothly and deliver high quality data you can rely on. Every time.
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.
To: Calyx
From: Top 5 Pharmaceutical Company
Subject: Calyx Medical Imaging helps get patients treated quickly
A very big thank you to Calyx Medical Imaging who worked outside of their turnaround timelines to review the scans that ultimately allowed the central team to approve enrollment to facilitate treatment of this patient as quickly as possible. This is a true testament of our values in ensuring that we get treatment as quickly as possible to patients that are in need.
To: Calyx
From: Top 5 Pharmaceutical Company
Subject: IRT team are great collaborators
I’m very happy with the collaboration we have seen with Calyx’s IRT team, their open communication, and their ability to discuss and solve issues.
To: Calyx
From: Top 5 Pharmaceutical Company
Subject: Calyx Medical Imaging Made this Approval Possible
A big thank you to the Calyx Medical Imaging team. This (approval) is also your accomplishment, and you should be very proud of the work you have done to make this possible. More approvals to come!
– Global Trial Manager
Liver Cancer Development Program
TO: Calyx
FROM: Veralox
SUBJECT: Calyx Medical Imaging – Thank you for meeting tight timelines
I am very impressed with the Calyx Medical Imaging team who have been incredible collaborators in helping us to advance our lead program. We especially appreciate the team working on tight timelines to help us meet our study start initiation goals. Given that we are a small company, we rely on our collaborators, and the team at Calyx works seamlessly beside us to help us advance our development programs. I look forward to continuing our partnership!
– Alicia Herr, PMP,
Veralox Therapeutics
To: Calyx
From: Top 5 Pharmaceutical Company
Subject: Calyx Medical Imaging – Transparent, Constant Collaboration
We worked very closely with Calyx on the pivotal uterine fibroid studies. Critical components of success included transparent constant collaboration with real-time communication at all levels between our study team and Calyx. This kind of communication throughout the life of the study helped to ensure our team had the information needed to make timely informed decisions and to deliver quality data for our deliverables. We were able to establish lessons learned from prior studies and implement those on this study. I’m looking forward to continuing our work together as we strive to bring more treatment options to women.
To: Calyx
From: Arrivent
Subject: Global Oncology Program – Calyx Medical Imaging Head and Shoulders above the Rest
I am writing to give testimony to the expert independent central imaging review services provided by Calyx in support of two of ArriVent’s global clinical oncology studies. Calyx has deep technical expertise in various tumor response criteria, imaging modalities, image collection logistics, data management and regulatory requirements. They gave ArriVent invaluable advice during protocol and charter development. This is coupled with a team of world-class highly specialized independent radiologists, imaging scientists, project managers, medical writers, a very efficient budget and contract group as well as superb internal processes and systems all of which contributed to a very smooth program kick-off for our lead molecule.
We have interviewed a number of different imaging CROs and Calyx is definitely head and shoulder above the others.
– Morgan Lam
SVP, Development Operations & Business Management,
Arrivent Biopharma
To: Calyx
From: Top 3 Pharmaceutical Company
Subject: Thank you Calyx Medical Imaging – Osteoporosis Trial Success
I would like to thank the Calyx Team very much for your contribution to this wonderful study outcome. Without you this marketing authorization would have never been possible.
-Medical Lead, Osteoporotic Trial,
Top 3 Pharmaceutical Company
To: Calyx
From: ProTrials
Subject: Pleased to partner with Calyx
We’re pleased to partner with Calyx and are confident that our customers will benefit from the scientific, medical, and clinical expertise they have honed during their 30 years of delivering reliable eClinical solutions to the clinical development industry.
– Christy Meyer
Director, Quality Insurance,
To: Calyx
From: LG Chem
Subject: Calyx IRT – Simplifying Complicated Randomization
I sincerely appreciate your cooperation and Calyx’s team effort for our program.
We could not have successfully completed the IRT development for both Ph3 studies without Calyx’s team expertise.
As you know, our Ph3 studies are very complex and your high degree of experience, knowledge and system (platform) were required in order to develop the IRT we wanted. Also, there were some challenges and concerns due to protocol amendment by LGC during IRT development.
But, we relied heavily on Calyx’s expertise in IRT to deliver these two complex trials in our Gout program. Calyx made recommendations on how to overcome some of the challenged we were facing, and it resulted in a solution that perfectly meets our needs.
I have been working for 13 years in clinical development area in pharmaceutical industry. Even if my experience was relatively short, I can tell that Calyx’s platform is very valid and elaborate compared to other IRT systems.
Thank you so much.
– Younghwan Jang,
Study Lead,
LG Chem, Ltd.
To: Calyx
From: ClinChoice
Subject: Partnering with Calyx for reliable data outcomes
We chose to partner with Calyx due to their tenured scientific, medical, and technical teams who possess a depth and diversity of experience in providing reliable data outcomes.
– Tiepu Liu, President,
Global Biometrics,
ClinChoice
