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2021 brought with it many healthcare advances – the most monumental being the availability of numerous COVID vaccines to bring an end to the global pandemic. The year also brought many other advances, and opportunities for life science professionals to stay up to date on the research, technologies, and processes that are driving change in how new medical treatments are developed and ultimately approved for worldwide use.

So here, in case you missed them, are the ten most downloaded articles, white papers, webinars and more produced by Calyx scientific, technical, and regulatory experts last year. Each provides direction and perspective on optimizing and accelerating the clinical development and approval of medical treatments. We hope you find them as insightful and valuable to you now as they were the first time around.

Behind the Breakthrough
Behind the Breakthrough (White paper)

When breakthrough therapy designation is granted, the challenges of clinical trial imaging increase. This white paper presents an insider’s view of what happens when the stakes, scrutiny, and demands of clinical trial imaging are sky-high, to help you get medical imaging done right in your accelerated trial.

READ NOW
Direct-to-Patient Shipments: It’s All in the Details (Published article)

While Direct-to-Patient (DtP)shipping offers potential advantages in improving clinical trial patient engagement, this approach is not as simple as it sounds. This article from International Clinical Trials outlines the pros, cons, and factors to consider when designing decentralized or hybrid clinical trials that include a DtP approach.

READ NOW
Myeloma Trials: The Changing Landscape of Imaging in IMWG Response Assessment (Webinar)

Focusing on the use of PET and addressing key problem areas in response assessment seen frequently in clinical trial settings, this virtual panel of IMWG 2016 authors and imaging experts answered questions about optimizing imaging-related assessments in multiple myeloma trials and shared their expertise in imaging as well as the clinical parameters in myeloma response assessment for running successful myeloma trials.

WATCH NOW
CTMS: Key to Unlocking Clinical Data Power (Podcast)

Listen in and learn how clinical trial management systems can adapt to support positive industry changes, including advances in user interfaces, integrations, and the ability to use CTMS as a data hub to better surface clinical trial risks.

LISTEN NOW
Data, Data, Who Owns the Data? (Calyx Cafe video)

Calyx’s Craig Mooney reflects on recent changes in the regulatory landscape that emphasize the investigative site’s ownership of IRT data collected during clinical trials, and considerations for making progress toward this goal.

WATCH NOW
A Guide to Bringing Regulatory Publishing In-house (Blog)

Regulatory publishing is the backbone of any pharmaceutical, biotech, or medical device business. Do you know what needs to be considered as you bring publishing activities in-house? This guide outlines everything you need to know.

READ NOW
Imaging Biomarkers in Phase 1 Oncology Trials: Choosing the Right Strategy (Webinar)

What biomarker to target? Is Blinded Independent Central Review necessary? Should we ‘Collect & Hold’? In this live panel, Calyx medical imaging experts answered questions about how to succeed in early phase oncology.

WATCH NOW
Understanding the Machine: Can Humans and AI Work Together (Calyx Cafe video)

You won’t want to miss this episode of the Calyx Cafe where our host explains how AI can benefit randomization and trial supply management processes. You’ll never believe who’s asking the questions!

WATCH NOW
Reducing Clinical Trial Lab Data Variability through EDC (Blog)

Learn how to prevent data variability and potential clinical trial delays by normalizing local labs data with advanced EDC systems.

READ NOW
The Ultimate Guide to IRT approaches that help with reducing drug waste (Guide)

Understand the various factors that drive drug wastage in clinical trials and the different IRT approaches that can be used to reduce each in this ultimate guide.

READ NOW

We’ll be delivering more valuable content coming throughout 2022 to help you achieve your clinical development objectives. Subscribe to make sure you don’t miss out!

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Clinical trial management system delivers heightened data security, open connectivity, and improved trial efficiencies

Nottingham, England and Morrisville, NC – December 14, 2021 – Calyx, the eClinical and Regulatory solutions and services provider most relied on for solving complex data challenges in clinical research, today announced an extended partnership with one of the world’s Top 5 clinical research organizations (CRO). The arrangement enables the leading CRO to continue providing Calyx’s proven clinical trial management system (CTMS) and services to its global biopharmaceutical customers for an additional three years.

Calyx CTMS delivers robust features that simplify the oversight of clinical trial operations, improve data quality, and reduce trial timelines and cost. The leading CRO selected Calyx CTMS based on its use of Microsoft’s Azure cloud technology, which improves clinical trial efficiencies while addressing the significant privacy, security, and compliance challenges that face the pharmaceutical industry today.

“Calyx is committed to delivering high integrity services and enabling our customers to leverage open, interoperable, and flexible connectivity that best fits their business needs,” said Serena Barker, Vice President of eClinical at Calyx. “We’re delighted to extend our partnership with this leading organization and to continue delivering the central CTMS solution and services its many diverse customers are leveraging to achieve more efficient, successful clinical trials and bring treatments to patients faster.”

Calyx CTMS is underpinning the entire development process for this CRO, enabling its 8,000+ users to boost productivity through the system’s 60+ integrations, centralize operational data for informed decision making, and improve the management of today’s clinical trials with tools that address the complexities of traditional and decentralized trials.

 

Click here for more information on Calyx CTMS.

About Calyx

Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and more than 25 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

Medical Imaging | IRT | CTMS | EDC | RIM

Take your trials further with intelligent insights at Calyx.ai or at LinkedIn, Twitter, or Facebook.

Contact:

Christine Tobin | Christine.Tobin@Calyx.ai | +1 412-628-8598

Regulatory Professional readers who recognise the following image can surely appreciate just how far we have come in the last 25 years.

Let’s recall the dark old days when major marketing applications for local affiliates arrived from head office ready-printed, on paper, literally on the back of a truck.

From my own experience, working in the Australian subsidiary of one of the largest global pharma companies, adjustments to meet local requirements would inevitably need to be made. This meant a large (or very large) repagination effort of the dossier, using the above torture device.

Eventually, all was well, all was complete, and the submission was sent off to the Therapeutic Goods Administration. On another truck.

numbering-machine
Figure 1: A numbering machine

Presently, we remain heavily reliant on documentation to communicate and exchange information around drug development. Slowly but surely, however, we are moving inextricably away from documents and towards data.

the-movement-from-paper-documents-to-digital-datasets-over-time

The volume and complexity of submissions are increasing exponentially. For example – there are a couple of orders of magnitude differences in the number of data points in XEVMPD and the complete ISO IDMP schema.

With the preparation for IDMP, a lot of effort over the last several years has involved finding the source of truth for a great many additional pieces of information required in this new standard.

Each company has had to identify which of their internal departments owns the information, and the format in which that information currently resides. Often, the information needed sits in a dusty warehouse, in an archive. On paper.

Varying proportions of manual work and technology, including optical character recognition and artificial intelligence (e.g., natural language processing, machine learning) have been deployed, with varying degrees of success, to extract structured data from the unstructured data in documents.

Structured content authoring, where existing data is used to create the still-required documents of today, might perhaps be viewed in the future as a ‘holding technology’ which eases current outdated document shuffling, not unlike my digital photocopier of twenty years ago.

CALYX-20-Headshots-SandraVignes-FINAL

“Ongoing initiatives to transform regulatory data exchange will drive improved efficiencies and transparency while reducing costs and review times, bringing new medicines to patients sooner.”

– Sandra Vignes, Technical Solutions Director, Calyx

Certainly, because documents remain important today, it makes sense to invest in the best DMS to meet your needs, knowing that it will become less important in regulatory affairs as time moves on.

The drive from documents to data is unrelenting. We are likely to see the end of the dossier in the coming years.

Projects are already underway to transform the way regulatory data is exchanged, to bring indirect data interchange via the cloud, between marketing authorization holders and regulatory agencies. This will drive efficiencies and cost savings, better transparency, and reduced review times, bringing new medicines to patients sooner.

As has been already the trend, datasets will become larger and larger. This combined with more global standardization, like multi-regional IDMP adoption, means safety signals will be generated earlier. Regional interoperability, such as cooperation on international prescriptions, and against drug counterfeiting, will be very much enhanced.

Combined with artificial intelligence tools, such as the Alphafold project by Deepmind, the utilization of data will continue to expand. Solutions to one challenge will open opportunities to solve many more.

Fasten your seat belts.

Learn how Calyx RIM can help you stay regulatory compliant.

Ability to meet evolving requirements, including IDMP, ensures regulatory compliance for leading companies

Nottingham, England and Morrisville, NC – November 1, 2021 – Calyx, the eClinical and Regulatory solutions and services provider most relied on for solving complex data challenges in clinical research, today announced that two of the world’s Top 5 pharmaceutical companies have chosen to continue using the Calyx Regulatory Information Management (RIM) system for streamlining and optimizing their regulatory affairs processes. Based on their successful experiences and trust in Calyx RIM, the organizations have extended their contracts for up to five years.

Both organizations are relying on Calyx RIM to ensure compliance with increasingly complex global publishing requirements and for the management and tracking of detailed product information, registrations, and authorizations. In addition to complying with regulations enacted to ensure patient safety worldwide, these leading global pharmaceutical companies will leverage Calyx RIM to adhere to the Identification of Medicinal Products (IDMP) standard that will begin having an impact on European registrations in 2022.

“By choosing to extend their use of Calyx RIM, these leaders in the pharmaceutical industry have substantiated the true value Calyx RIM delivers,” said Jo English, Vice President, Regulatory Information Management, Calyx. “We’re honored to have earned their trust and to continue delivering the robust tools they need to comply with IDMP and other regulatory requirements, ultimately helping patients around the world maintain access to much-needed medical treatments.”

This marks three long-term Calyx RIM contract renewals signed by Top 10 Global Pharmaceutical companies in the past month.

 

Click here for more information on the benefits of Calyx RIM.

About Calyx

Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and more than 25 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

Medical Imaging | IRT | CTMS | EDC | RIM

Take your trials further with intelligent insights at Calyx.ai or at LinkedIn, Twitter, or Facebook.

Contact:

Christine Tobin | Christine.Tobin@Calyx.ai | +1 412-628-8598

With the first “optional” submissions of IDMP data for Centrally Authorised Medicinal Products within the European Economic Area (EEA) now only a matter of months away (currently scheduled for Feb 2022), Calyx Regulatory Information Management (RIM) implementation experts are sharing their perspectives on its impacts and how sponsors can address them to reduce burdens while ensuring compliance with the new standards.

In this first installment, we talk to Darren Oakes, Manager of Regulatory Implementation at Calyx. He reflects on how IDMP builds on XEVMPD and the improvements which IDMP will bring to the capture of the data.

How does IDMP build on XEVMPD?

With the implementation of XEVMPD in 2012 the industry had its first glimpse into how structured regulatory data could be captured and submitted.

While XEVMPD met Article 57(2) of Regulation (EC) 726/2004 requirements to create and maintain a database of all authorized medicinal products for human use within the European Economic Area, its implementation ended up producing disparate versions of the same information. This caused a significant amount of effort to reconcile updates from agencies back into sponsors’ systems which were already being maintained with the life cycle of the product data.

Since then, we have seen the continued extension and evolution of requirements, ultimately leading up to where we are now with the latest updates reflecting today’s needs post-pandemic (and Brexit).

What is the lift now for sponsors as they move to IDMP?

— To enrich their existing XEVMPD data with the new data points for IDMP

— To incorporate the maintenance of these into their processes

— To look at the sources of data and integration points to avoid maintenance of multiple data sets

What do you think is the biggest impact from a data perspective?

The structure with which to capture the data in IDMP reflects the reality of how medicinal products are authorized. It doesn’t sound like much, but this is a good change for the industry. It may also provide the impetus for the industry to align and update their SmPC and other labeling documentation.

What does that mean in real terms?

Well, if I take a Centralised Product, for example, it has a registration number per package set. That means if a tablet is delivered as 2×5, 4×5 and a 6×5 blister pack, each of these packs has their own EU license number. For XEVMPD the tablet details are tracked for each of those three license numbers.

In IDMP the tablet details are tracked only once, and the three license numbers are linked to that tablet.

The challenge to duplicate the data into the XEVMPD granularity has been a pain point for years as it doesn’t reflect the regulatory processes or how clients typically track their data. The change with IDMP makes sense, as there is less duplicative data to track.

Conclusion

Stay tuned for future installments to this series, where Calyx RIM implementation experts review the impacts of IDMP and how sponsors can prioritize and address them to ensure their compliance with the new standards.

Darren Oakes and XEVMPD

About the Author

Darren Oakes – Manager, Regulatory Implementation

Darren Oakes has over 20 years working within the pharmaceutical industry and brings a wealth of experience in regulatory information management (RIM). His current focus is on helping Calyx RIM clients optimize the management of their regulatory data. 

Discover additional resources to help prepare for IDMP implementation, and to learn more about how Calyx RIM experts can help.

Regulatory publishing solution selected based on reliability and innovation

Nottingham, England and Morrisville, NC – October 25, 2021 – Calyx, the eClinical and Regulatory solutions and services provider most relied on for solving complex data challenges in clinical research, today announced that one of the world’s Top 10 pharmaceutical companies executed a contract to continue its use of the Calyx Regulatory Information Management (RIM) system for critical submissions of clinical development data to global regulators through 2026.

The Calyx RIM publishing module enables pharmaceutical companies to easily compile and submit comprehensive dossiers to global regulatory authorities. Designed by Calyx in-house regulatory experts, Calyx RIM is a proven, robust tool that optimizes the regulatory submission process and is continually updated to reflect worldwide health authorities’ evolving submission specifications.

The Top 10 pharmaceutical company made its selection based on decades of experience with the Calyx RIM solution and the trust that Calyx will continue to support submissions across the company’s complex global portfolio. The value of the RIM system is further increased through Calyx’s partnership with Microsoft and its use of innovative, cloud-based technology that keeps customers ahead of evolving regulatory requirements. Calyx RIM on Microsoft Azure provides tailored, direct delivery of system updates based on users’ needs and schedules, ensuring minimal disruption and ongoing compliance with global regulatory requirements.

“We value the trust this global pharmaceutical company has placed in Calyx and are delighted to extend our relationship as we support the important work they’re doing to bring new medical treatments and vaccines to patients around the world,” said John Blakeley, Chief Commercial Officer at Calyx.

 

Click here for more information on the benefits of the Calyx RIM system.

About Calyx

Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and more than 25 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

Medical Imaging | IRT | CTMS | EDC | RIM

Take your trials further with intelligent insights at Calyx.ai or at LinkedIn, Twitter, or Facebook.

Contact:

Christine Tobin | Christine.Tobin@Calyx.ai | +1 412-628-8598

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