Recent research highlights the importance of developing and utilizing cost-effective, sensitive, and specific plasma biomarkers using commercially available assays for screening subjects in Alzheimer’s Disease (AD) clinical trials. This approach overcomes limitations associated with the clinical diagnosis of AD, especially in individuals with mild cognitive impairment or dementia who exhibit typical AD symptoms lacking Aβ pathology.

There is evidence that targeting p-tau217 in blood has yielded the best results as a diagnostic and prognostic tool for assessing longitudinal change. Studies showed that the p-tau217 assay outperformed MRI and showed comparable performance with CSF biomarkers in detecting Aβ PET positivity and tau PET positivity.

Utilizing the approach recommended by Alzheimer’s Association guidelines, commercial immunoassay has shown high positive and negative predictive accuracy at screening in clinical studies.

Learn about other advances in Alzheimer’s Disease research, including why the FDA’s recognition of using medical imaging as an objective biomarker is a big step forward for the clinical development of new AD treatments.

De-risking Medical Imaging in Solid Tumor Trials

During anti-tumor treatment development, imaging modalities, criteria, and regulators’ expectations change frequently. Without the direction of imaging scientists who work day in and day out in clinical trial imaging, it would be difficult, if not impossible to keep track of and react to changes during these critical and often, lengthy trials.

Successful medical imaging in solid tumor trials requires professionals with therapeutic experience, expertise in the modalities required to demonstrate safety and efficacy, and first-hand insight into what global regulators will look for in your submissions.

This blog presents examples of scientific advances and regulatory changes that are currently impacting anti-tumor treatment research, demonstrating the need for an imaging partner who is immersed in the regulations, scientific learnings, and trends that could impact the success of your development program.

Overcoming Oncology RTSM Challenges with Advanced IRT

Sponsors of oncology trials face unique randomization and trial supply management (RTSM) challenges, including:

• Central vs. local sourcing of standard-of-care treatments
• Unknown patient treatment duration
• Impact of rescue medication on study drug expiration
• High cost of treatments / need to reduce excessive drug wastage

Learn about these and other supply challenges and how a flexible IRT system can reduce errors, ensure patient safety, and meet changing RTSM during lengthy oncology trials in this article by Calyx’s Malcolm Morrissey, published in International Clinical Trials®.

Exceeding Timelines for Accelerated Approval: Calyx Medical Imaging

In oncology clinical development, every day matters. Even more so when your compound has been fast-tracked for approval by global regulators.

Which is why so many clinical trial sponsors rely on Calyx Medical Imaging. Calyx’s collaborative approach, ability to meet each sponsor’s unique needs, and expertise in image acquisition and analysis have repeatedly been proven to help clinical development programs succeed.

Like in this example, where Calyx Medical Imaging delivered critical imaging data in advance of deadlines on an already expedited timeline to help a leading pharmaceutical company receive accelerated FDA approval for a Multiple Myeloma treatment.

How IRT Expertise Surfaces – and the Difference it Makes

An IRT system is a critical part of a clinical trial. The implications for failing to get it right can be impactful not only to study goals but to participants as well.

Here, Calyx’s Craig Mooney gives examples of the consequences that can arise if a study’s IRT system isn’t implemented with insight and precise focus on the protocol’s needs and why expertise matters throughout the clinical trial lifecycle.

Calyx RIM Supports Successful FDA eCTD 4.0 Pilot

Calyx RIM has been successfully used by a global market-leading pharmaceutical company in FDA’s eCTD 4.0 implementation pilot program.

Calyx’s regulatory experts worked closely with this leading company and the FDA throughout the pilot and advanced Calyx RIM based on their feedback and lessons learned.

Learn why you can rely on Calyx RIM as you adopt eCTD 4.0 as part of your global regulatory processes.

Neuroimaging in Alzheimer’s Disease Trials

As our understanding of Alzheimer’s Disease (AD) pathophysiology continues to evolve, we’re seeing advanced approaches for assessing treatment effects in clinical development, including AI/machine learning to measure subtle changes that are difficult for the human eye to detect.

Calyx Medical Imaging delivers neuroimaging expertise to help sponsors meet the unique and emerging needs of early to late-phase AD clinical trials. This paper outlines Calyx’s capabilities and experience, which includes confirmation of eligibility and brain safety assessments with rapid turn-around times as well as advanced quantitative analyses for PET and MRI data to help your AD trial succeed.

Mitigate Unblinding Risks with Calyx IRT

Every clinical trial runs the risk of unintentional unblinding. With 30 years of experience designing reliable RTSM solutions and the processes behind it, Calyx IRT is the solution you can rely on to minimize these risks and ensure the integrity of your clinical trial.

The solution design and technical experts behind Calyx IRT have published a variety of papers, webinars, and blogs to demonstrate where and how unblinding can occur and more importantly, how to minimize those risks.

Calyx CTMS Select: Scalable for Small/Mid-sized Biopharma and CROs

The features of Calyx CTMS deliver significant benefits for studies of all shapes and sizes. However, not all studies have the same needs.

Enter Calyx CTMS Select, a pre-configured and validated clinical trial management system for small to mid-tier biopharmaceutical companies and CROs who want reliability and global support but don’t require CTMS customization.

Calyx CTMS Select enables SMID organizations to scale as their operations require and includes the rich features required for clinical trial management oversight and monitoring at lower costs than comparable solutions.

Cookie Cutter Solutions don’t Cut it in Clinical Trial Imaging

When medical imaging is used as a clinical trial biomarker, your centralized core lab provider needs therapeutic/modality and operational expertise to help you meet your development objectives, regardless of where you are in the clinical development spectrum.

Here we review how a small biotech captured the imaging data needed to secure funding and advance their early-stage research on a rare neurological disease compound. And, how a top 5 global pharma captured reliable primary efficacy endpoint data in a pivotal phase III study to achieve regulatory approval on a prostate cancer compound. All supported by Calyx Medical Imaging.