Architecting a foundation of AI-ready data

While evolving compliance standards, like IDMP or eCTD 4.0, or the adoption of digital agents can trigger internal alignment on data remediation efforts, organizations like CSL and Alfasigma have elevated these conversations beyond a basic compliance exercise.

“We had to change our perspective and show the real business value that we could create from IDMP. We built a business case beyond compliance that led to organization-wide buy-in, a first-of-its-kind data governance model, and improved traceability,” said Michele Malossi, manager of regulatory digital at Alfasigma.

Similarly, CSL undertook a large-scale data audit to understand each business function’s data domain and use cases. Ultimately, they built a data foundation that illustrates how data flows through the organization, including who produces and consumes it, so teams can make data-driven decisions across R&D.

Scaling with intelligent automation and AI

By embedding intelligent automation into daily workflows, regulatory teams are successfully freeing themselves of administrative, low-value tasks to focus on global submissions.

For mAbxience, implementing standard �Թϱ��� RIM configurations allowed them to build advanced AI capabilities including document classification bots, an internal knowledge chatbot, and generative dossier summary tools, which freed the team to focus on complex regulatory tasks and continuous process improvements.

“It’s not about taking jobs from people. It’s to help them with basic tasks, gaining time, and work on more difficult regulatory operations where their knowledge is needed,” said Aurélie Bequet, head of regulatory operations at mAbxience.

Business transformation in the age of AI

Each organization will execute change management in their own way, but buy-in is a key determinant of success. “You must win hearts and minds. You must articulate why change is needed, how it will benefit the organization, and what value will be realized from the investment. It’s equally important to get emotional buy-in, which impacts the workforce as a whole. The user community should feel understood and supported during the change,” said Javier Monvoisin, global head of regulatory operations at Sandoz.

Long-term business transformation requires ongoing investment from the team to rethink processes. During its �Թϱ��� RIM transformation, MSD used functional area collaboration teams to identify necessary capabilities. “We were able to create sustainable process change and deliver on outcomes faster,” said John Janick, executive director of regulatory innovation and information management at MSD.

Additionally, the company is using AI to evolve its operating model. “Historically, we’ve looked at processes first, the people in the roles that execute, and then how technology enables them. With the advent of automation and agentic labor, we can look at the technology first to help us in designing a better process,” said Janick.

To learn more about how organizations are building a reliable data foundation, adopting AI, and succeeding in transforming their operating models, join us at �Թϱ��� R&D and Quality Summit in Boston on October 20-21, 2026.

The post Modernizing Regulatory Operations with Automation and AI first appeared on �Թϱ��� Systems Europe.

The ICH Implementation Guide (v1.6) was published in May 2024, and more regional implementation guides have been finalized, with more underway. In Japan, eCTD 4.0 is now mandatory, the FDA now accepts voluntary eCTD 4.0, and the EMA is strongly recommending eCTD 4.0 for new Centralised Procedure MAAs starting in Q1 2027.

Global regulatory agencies are defining mandatory dates for eCTD 4.0. Proactive planning is essential, since eCTD 4.0 incorporates a number of new concepts that differ significantly from previous versions. Regulatory leaders will benefit from diving into the specifications and regional guidance to determine how it will change practices within their companies and teams. The is updated bi-annually with the latest pilot and implementation timelines, including links to the dedicated regional implementation documentation.

An evolution of the eCTD standard

eCTD 4.0 updates the global standard for electronic regulatory submissions to improve processing consistency for both publishing teams and regulatory reviewers. Since its introduction in 2002, the eCTD framework has transitioned the industry away from paper dossiers to mandatory electronic submissions, which the FDA formally enforced in 2018. Although some industry perspectives note that the update does not adopt more advanced data-driven capabilities, eCTD 4.0 introduces distinct technical enhancements and updated lifecycle management features.

A simplified global standard

While eCTD 3.2.2 provided a global standard format, country-specific nuances remained, such as the use of node extensions or Study Tagging Files (STFs). In contrast, eCTD 4.0 provides a single, unified format that is used across all regions. Each region determines which components of the format to implement to address its unique requirements (such as territorial authority). This establishes a more harmonized global approach, with a single submission unit XML output, while still allowing for region-specific controlled vocabularies that define things like the eCTD Module 1 structure.

The changes result in more consistent processes for regulatory activities. By using the same schema from region to region, it is easier for users to reuse content. There are fewer manipulations to the structure to ensure it will be accepted by the target country. The use of controlled vocabularies in eCTD 4.0 allows updates to the regional specifications to be made without major changes to the underlying schema. A controlled vocabulary for a manufacturer can now be defined globally, rather than application-by-application. Sponsors must rethink how they submit and enrich data in existing systems to prepare for eCTD 4.0.

While it was possible to reuse data and documents in eCTD 3.2.2, eCTD 4.0 encourages leveraging documents through unique identifiers. This allows for documents to be reviewed once and used across multiple applications to the same regulatory agency. Systems like �Թϱ��� RIM Submissions Publishing, which are unified with a document management system, can now calculate if a document was already sent and automatically write the XML to contain the unique identifier to exclude the document from the submission package. This also means the agency doesn’t need to re-review the same document multiple times, resulting in a more efficient process.

�Թϱ��� Submissions Publishing supports all new lifecycle operations natively.

How �Թϱ��� RIM facilitates eCTD 4.0 success

�Թϱ��� has enhanced �Թϱ��� RIM applications — �Թϱ��� Submissions, Submission Publishing, Submission Archive, and Registrations — to fully support eCTD 4.0.

Released data model changes enable sponsors to start enrichment projects, submit eCTD 4.0 applications to Japan’s PMDA, and participate in FDA pilots, including the recent forward compatibility pilot. As other regions solidify their roadmaps, additional local support will become available.

Read about and �Թϱ���’s Health Authority Gateway to learn more about how �Թϱ��� facilitates e-submission.

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with eCTD 4.0 first appeared on �Թϱ��� Systems Europe.

But, what does risk-based QC mean in practice? Key principles, as highlighted by CDISC and industry guidance, include:

• Risk proportionality: The need to move beyond a “one size fits all” QC approach, recognizing that risk is multifactorial and contingent on trial design, technology, and operating model.
• Criticality focus: Baseline TMF controls should be modified based on the potential threats to patient rights, data integrity, and document “essentiality.” This means focusing on elements critical to trial quality.
• ALCOA+ principles: Risk-based QC must ensure that essential records consistently meet the data integrity standards of Attributable, Legible, Contemporaneous, Original, Accurate, and Complete (ALCOA+).

Operationalizing risk-based QC in �Թϱ��� eTMF

�Թϱ��� eTMF users can put this methodology into practice by leveraging the feature embedded directly into document workflows. This shifts the QC burden from a manual, high-volume process to a targeted, automated system – ultimately removing the reliance on manual spreadsheets.

The feature is driven by a configurable setup that determines which documents require a full quality check, including:

1. Document type risk mapping: Organizations first associate specific document types to a pre-defined QC risk level (e.g., high, medium, low).
2. QC risk rules: TMF teams can create rules to define a sampling percentage for each risk level. For maximum flexibility, they can be set generically or refined based on the study, country, and/or organization.
3. Automated risk assessment: When a document enters a QC workflow, the system automatically executes the risk assessment. This provides a clear, traceable audit trail for all risk assessments.

Improved inspection readiness and oversight with risk-based QC

By automating the risk-based QC process, TMF professionals can benefit from:

• Time savings and maximized resource allocation: �Թϱ��� eTMF directs QC efforts to only the necessary subset of documents. By reducing the manual, high-volume QC burden, organizations can save time and free up teams to focus on the most critical content or high-risk processes.
• Continuous inspection readiness: Having an automated, real-time QC strategy ensures the TMF is managed actively. This eliminates the need for costly, high-effort end-of-study remediation, ensuring the TMF is in a constant, auditable state of compliance.
• Audit-proof traceability and compliance: Every document is stamped with a system-generated risk assessment outcome (QC required or QC not required). This provides an audit trail that demonstrates to inspectors and auditors that a robust, compliant risk-based process was executed for every record.
• Proactive quality oversight: The platform automatically generates risk rule metric records that track document volume and QC needs. Real-time dashboards and reports provide immediate visibility, allowing organizations to monitor QC performance, address process bottlenecks proactively, and continuously refine their risk-based approach.

By moving away from manual checks toward a targeted approach within �Թϱ��� eTMF, TMF teams can focus their energy where it matters most: on high-impact, critical trial content.

Learn more about how �Թϱ��� eTMF can support risk-based QC.

The post How TMF Leaders Can Drive Risk-Based QC in �Թϱ��� eTMF first appeared on �Թϱ��� Systems Europe.

PV teams are struggling with the gap between the promise of AI and the operational reality. AI will undoubtedly add value to PV operations. Until then, the day-to-day workloads including case intake, literature reviews, and aggregate reports, continue to increase while headcount remains flat and operational costs rise.

As workloads grow, lean teams face increasing pressure to adapt by adopting AI and new ways of working or risk falling behind. With continual AI announcements and new vendor automation and AI offerings—some proven and others aspirational, it can be difficult for teams to separate the signal from the noise. Most organizations cannot afford to pilot multiple AI solutions to determine value, especially with the required validation and change management efforts.

So where should teams start? Begin by asking these two questions to guide a strategy that supports immediate results and future growth:

• Where can AI deliver the greatest value today? Understand where your teams are spending the most time on repetitive, manual work.
• Do you have the right foundation for AI? AI is only as effective as the data and processes that support it.

Identify high-impact opportunities to deliver immediate value

Key opportunities for AI and deterministic automation are repetitive, manual processes that consume the most time. Here are two examples highlighted in recent conversations with PV leaders:

• Literature reviews: A PV leader with a team of four told me he spends a minimum of 10 hours a week combing through literature articles and navigating spreadsheets from his vendor.
• Duplicate case detection: Another safety operations head tracks duplicates manually in Excel every Monday because his vendor charges for every case touched, even if it is invalid or a duplicate.

Headcount rarely grows ahead of demand, but case volumes, SDEAs, and reporting obligations continue to increase. Organizations that scale most effectively aren’t simply adding people; they’re building a foundation that allows AI and automation to take on more work without linear headcount growth.

Build the foundation to scale AI

The right foundation starts with your safety data and processes. If your safety operations, data, and content are fragmented across multiple systems, or your safety data is managed outside of your PV system by CROs, it will take more time and effort to realize value from AI.

Organizations that own its safety data and content within a unified safety platform improves operational efficiency through connected processes and deterministic automation. It also provides the context needed for native, industry-specific AI to support PV-specific tasks, workflows, and business processes. Sponsors, CROs, and other partners can collaborate in the same sponsor safety system, improving security, compliance, data consistency, and operational efficiency.

What’s eating up your team’s time right now? Send me an email and let me know. Your feedback directly shapes what we cover next.

A couple of quick opportunities in the meantime:

• Join our upcoming to learn more about �Թϱ��� AI and where we are heading. Livestreams are hosted on �Թϱ��� Connect, so you will need to use your company email address for access.
• Save the date for �Թϱ��� R&D and Quality Summit in Boston (Oct 20-21). We are hosting an invite-only roundtable for emerging biotech safety leaders. Send me a note if you’d join us.

�Թϱ��� R&D and Quality Summit in Boston

Discover ways to simplify pharmacovigilance operations with seamless global to local processes, AI, end-to-end automation, and real-time partner collaboration.

Read more Safety newsletters here and for the latest industry insights and technology innovations.

The post AI in Pharmacovigilance: Separating Signal from Noise first appeared on �Թϱ��� Systems Europe.

An in-house sponsor PV system that CROs and other partners can work in is a more efficient approach. Sponsors have direct oversight of PV activities, real-time data access and visibility, and can improve audit-readiness and overall responsiveness to critical safety issues — whether it’s signal detection or addressing an audit finding. An in-house model also sets the right foundation for long-term growth, for example, enabling faster expansion into new markets or connecting to clinical and regulatory systems to drive greater business process efficiencies.

“We prefer to keep our clinical, regulatory, and PV systems in-house because we want to be independent. The data the system generates is critical for understanding a product’s safety profile and for compliance with regulatory requirements,” says Francia Razafy, safety systems administrator, Debiopharm International SA. “And if we decide to outsource the system, we risk losing control and the availability of that data.”

Read on to learn how Debiopharm and a small, research-based biotech implemented in-house safety models that fit their business needs while improving operational oversight and efficiency.

How in-house PV systems set the foundation for growth

PV operations at every biotech are different. For clinical-stage companies, the focus is on standing up critical PV processes quickly with limited resources. For more mature organizations, the focus may be on expanding into new markets or treatment areas. Regardless of the goal, how the safety system is set up can determine whether it is a strategic asset — improving product safety, compliance, and business agility — or an operational constraint — siloing data, slowing down processes, and creating business risk.

Debiopharm wanted to upgrade its existing in-house safety system that required extensive database maintenance along with limited oversight of CROs and inadequate reporting capabilities. For the small, research-based biotech, the goal of bringing safety in-house was to create a fully compliant PV system that could scale with its business and create operational efficiencies over time.

“We wanted to future-proof the system, “ says the biotech’s PV manager. “We currently have sites in the UK, but we are looking to open sites in the EU this year, and we knew we could do that smoothly with a new PV system in place.”

As biotechs evaluate the best way to set up — or reimagine — their safety system, here are three questions they should ask:

Will I have real-time access to my safety data? One of the most significant risks of fully outsourced safety systems is the loss of data visibility and control over safety outputs. First, outsourcing safety data can create significant lag time — days, in many cases — even for basic data queries and reporting, creating compliance risks. Second, there can be unexpected or hidden costs, especially for custom reports or data migrations. Third, depending on the model, safety data could reside in a number of different systems, limiting insights and interoperability with other functions.

“We have increasingly complex reporting requirements,” says the PV manager at the research-based biotech. “These just weren’t possible with our previous supplier without a high cost of implementation. We really wanted the flexibility to generate reports as needed.”

Other biotechs see the benefit of clear data ownership, as well. “I’m a big advocate for owning your data. The lift is not any different when you own your system. You’re still paying the same amount of money and it takes the same amount of work. But, if you’re paying someone else to do it for you, you don’t get visibility into it,” says a pharmacovigilance director at a dermatology biopharma.

Can my PV system scale over time? For clinical-stage biotechs, it may seem easiest to focus on the task at hand — setting up a compliant safety function quickly and cost-effectively. But, handing over your safety system to a CRO may not be the best solution long-term. What happens when the company is ready to expand to new markets or treatment areas? Often, biotechs will need to add more partners over time with specific expertise, and it can further fragment safety data, requiring cumbersome integrations or manual effort while increasing costs.

Another biotech company’s senior medical director for global safety and risk management explains that fragmented data impacted safety processes: “A lot of our information was disjointed. Our safety database wasn’t in-house, our source documents were in different locations, and our vendor used different teams to handle processing and review.”

Does my PV system add business value and efficiency? Historically, pharmaceutical companies operated with siloed systems within the different functions, but that’s changing. When establishing a safety system, think about the interoperability with other systems and what kind of business benefits you can create. For example, the Safety-Clinical Operations Connection automatically transfers data from �Թϱ��� Clinical Operations to �Թϱ��� Safety for a seamless flow of safety letters to �Թϱ��� eTMF and eliminating manual study record reconciliation. But, if safety data and processes are fragmented across multiple systems or partners, it can slow activities and increase compliance risk.

Implementing the Safety-Clinical Operations Connection allowed Debiopharm to save time and remove duplicate study creation work done by several business administrators. Using �Թϱ��� Safety’s database improved oversight by enabling automatic and full workflows for open label and blinded studies with readable audit trails. The introduction of KPI reports in �Թϱ��� Safety also increased the company’s CRO oversight.

Establishing an in-house safety system doesn’t mean PV teams can’t engage CROs and other partners to provide specific expertise or resources. Debiopharm partners with a CRO on safety activities, such as case processing, while maintaining an in-house system that improves oversight, efficiency, and data quality.

Implementation best practices for an in-house safety system

Establishing or moving to an in-house safety system has significant upside, but how you approach it will impact the speed and success of your implementation. In some cases, companies will consolidate several different safety systems. Others will need to look closely at data hygiene and architecture, particularly across different functions, to achieve more transformational value. And almost everyone will need to focus on creating a strong safety culture and change management mindset to ensure all stakeholders understand the “why” behind the decision.

For Debiopharm, it was important to approach the project with a long-term view. “It’s important to define clear governance before implementing technology, and to consider maintenance efforts more than implementation efforts,” says Razafy.

The PV manager at the research-based biotech agrees, adding, “It really helps decision-making to have clear user requirements that are not necessarily built around your previous system and your existing processes. Think more broadly about what you actually want out of your safety system.”

5 steps to a successful in-house safety system

Align on your data migration approach up front: “We had some challenges with data migration. And it was mainly because we were not able to provide data extracts from our previous system very early on in the project.” says the PV manager. “And that meant maybe we weren’t aligned right from the beginning on our data migration approach, and we maybe didn’t know our data as well as we thought we did.” She recommends spending time early on in the process to understand the data you want to migrate, and how you will extract it.

Define KPIs and reporting needs early: Understanding the KPIs and reporting needs upfront will help prioritize critical needs during implementation and minimize the need for custom reports down the road. It will also help establish the right level of oversight. “We worked with a CRO and implemented our KPI trackers directly in the system to track the CRO’s activities,” says Razafy.

Identify opportunities for cross-functional efficiencies: Identifying how safety data can and should be used across teams, including future use cases, will help your business scale quickly when the time is right. For example, consider how your safety database will connect to your EDC or regulatory systems to improve case processing. This can help you prioritize use cases, as well as identify areas where you can automate processes and reduce manual work.

Build a strong safety culture: Moving your safety system in house may be disruptive or intimidating at first, especially if you’re migrating from an existing system that may have been in place for years. Good change management practices are critical, including providing dedicated training and support, communicating frequently, and creating realistic timelines for change can all help. “Definitely update your internal documentation early,” says the PV manager. “I think we underestimated how many SOPs and guidance documents we would need to change.”

Foster a continuous improvement mindset: Moving your safety system in-house is about creating the foundation for future growth. Traditional safety systems may only see updates every few years, limiting innovation. �Թϱ��� Safety has scheduled releases three times a year, making it easier for PV teams to prepare for updates and new features in advance, assess potential risks, and then quickly validate the system.

Learn how other emerging and growing biotechs are gaining operational efficiency, direct oversight, and outsourcing flexibility by bringing their safety system in-house.

The post Debiopharm: Improving Safety Oversight and Efficiency for Sponsors and CROs first appeared on �Թϱ��� Systems Europe.

This technological evolution toward an autonomous TMF coincides with the EU AI Act taking effect in August 2026. Organizations using agentic labor within GxP processes will need to demonstrate effective human oversight and compliance with existing quality standards.

Here are five practical steps every sponsor and CRO can start today to prepare their data, processes, and people for agentic labor:

1. Get TMF data ready for AI agents

Agentic labor is only as reliable as the information it can access. Poor metadata, inconsistent naming conventions, incomplete filing, or low-quality scans will stall autonomous workflows. Preparing for agents begins with strengthening taxonomy consistency, OCR accuracy, and filing completeness. A well-organized, high-quality TMF provides the foundation for agents to accurately classify documents and manage expected document lists (EDLs).

2. Establish governance for agentic labor

As agents take on high-volume, repetitive tasks, governance becomes a core compliance requirement. Unlike assistive AI, agentic labor involves self-directed planning and execution. Organizations must define acceptable use cases for standard agent packs (such as intake or quality control agents) and map out how they align with existing quality management systems. Because TMF agents evaluate documentary evidence rather than direct patient care, risk assessments should focus primarily on data integrity and inspection readiness.

3. Update SOPs for the “human by exception” model

Agentic labor will fundamentally change how users interact with documents. Instead of manually reviewing every record, teams will transition to a “human by exception” model. Organizations must update standard operating procedures (SOPs) to define the confidence thresholds at which an agent can act autonomously versus when a document must be routed to a human for triage. SOPs must clearly document how these autonomous actions and human interventions maintain traceability.

4. Train your team to be process architects, not processors

The era of humans executing routine clinical trial logic is ending. Training should no longer focus on basic software clicks or “prompt engineering.” Instead, clinical teams need to be trained as process architects. This means educating users on how to provide strategic oversight, interpret agent-flagged exceptions, and define the clinical business rules that guide the agents’ behavior.

5. Build workflows that support contextual memory

Achieving an autonomous TMF is a progressive journey. When an agent cannot complete a task, human experts must step in via triage. Organizations should prepare to capture these human corrections so the agents can learn from them. By establishing workflows that utilize contextual memory, agents will learn specific business rules over time. This allows them to autonomously resolve the same exception the next time it occurs, driving continuous quality improvement.

Looking ahead at autonomous TMF

Organizations that invest today in clean data, updated SOPs, and training their teams as process architects will be uniquely positioned to scale agentic labor. The question is no longer whether agents will become part of eTMF management, but whether an organization is prepared to adopt them responsibly and build the foundation for a truly autonomous TMF.

Contact �Թϱ��� Business Consulting to learn how �Թϱ��� can help your organization prepare for an autonomous TMF.

The post 5 Things You Can Start Today to Prepare for Agentic Labor in Your eTMF first appeared on �Թϱ��� Systems Europe.

The reality is that changing your technology platform becomes significantly harder and more disruptive as your biotech company and its pipeline mature. Instead of waiting until your pipeline expands, establish deep technical roots before scaling. Standardizing on the right EDC platform across all clinical phases and studies – rather than switching tools based on early phase needs – reduces long-term complexity, lowers your total cost of ownership (TCO), and effectively prepares your biotech for sustainable growth.

The cost of fragmented systems

While this study-by-study approach might seem practical, it introduces hidden inefficiencies across your portfolio. Instead of building momentum, clinical teams lose valuable time starting from scratch for every single study because they lack a base standards library to build from.

This technical fragmentation quickly trickles down into everyday operations. Inconsistency across phases leads to disjointed downstream systems and data integrations. Critical data governance is often overlooked until data issues emerge late in the pipeline. Ultimately, the constant state of change management forces teams to waste resources on recurring vendor contracts, distinct system validations, and repetitive user training.

How a small biotech standardized for long-term scale

Benefits of broad EDC standardization

By standardizing EDC early, your data management team can begin contributing to a global standards library from day one. Instead of rebuilding the wheel for every trial, this foundational setup reduces the configuration and build effort required for all subsequent studies. Because most EDCs share similar core functionality, user preference among site staff and CRAs is heavily driven by familiarity. Keeping the same system across phases provides a consistent user experience. This is especially crucial for early-phase oncology trials where investigative sites are managing actual patients rather than healthy volunteers.

Beyond day-to-day usability, broad standardization improves your inspection readiness and financial efficiency. Having a single, unbroken audit trail across all clinical phases makes it much easier for your team to speak confidently to regulators during inspections. This approach also delivers a much lower TCO. By eliminating the operational drag of managing multiple software vendors, executing completely separate system validations, and maintaining scattered integrations, emerging biopharmas can protect both their timelines and their budgets.

Looking beyond the next study

Even if your company’s long-term vision isn’t fully certain, or if a phase II program is still three years away, planning for EDC standardization pays off unless your immediate strategy is to sell off the asset. Taking a short-term view of clinical technology only creates compounding technical debt. Emerging biopharmas do not need to navigate this journey alone. A comprehensive system like �Թϱ��� EDC provides the necessary speed and affordability upfront, while offering a clear offramp to transition complete data ownership back to the sponsor over time as your internal team and expertise grow.

The post A Business Case to Standardize EDC Across Study Phases first appeared on �Թϱ��� Systems Europe.

From managing regulatory complexity to Clinical Trials Information System (CTIS) limitations, here are five key topics disclosure leaders discussed at �Թϱ���’s recent R&D and Quality Summit.

#1. Prepare for manual CTIS workflows as the EMA prioritizes stability

The European Medicines Agency (EMA) is prioritizing operational reliability and core CTIS modules over new innovation.

A key challenge is the lack of bidirectional API functionality between CTIS and sponsor systems. Because the EMA is unlikely to overhaul these APIs before 2028-2029, sponsors and CROs must prepare for heavily manual workflows.

#2. Leverage structured data for CTIS preparation

Without bidirectional APIs, managing data governance across TMF and RIM systems is resource-intensive and error-prone. Simple document misclassifications create major compliance and confidentiality risks.

Sponsors can mitigate this by pulling structured data directly from CTMS to auto-populate disclosures. This replaces manual entry risks with accurate, pre-packaged PDFs ready for CTIS upload.

#3. Bridge the gap between clinical operations and regulatory affairs

Silos between clinical operations and regulatory affairs cause process disconnects and ambiguous CTIS ownership. With health authorities requiring responses within 48 hours, organizations must unify workflows to meet RFI timelines.

Connecting start-up documentation with RIM data gives teams real-time visibility into protocol changes for faster turnaround times.

#4. Anticipate IVDR as the next major regulatory risk

In Vitro Diagnostic Regulation (IVDR) requirements are already active, even though the European Database on Medical Devices’ portal won’t launch until late 2026 or 2027. This gap forces organizations to navigate fragmented local ethics processes.

Additionally, IVDR performance studies do not map cleanly to existing clinical and regulatory architectures. Sponsors anticipate this will become an operational hurdle over the next 12-24 months.

#5. Put redaction and AI on your roadmap

Managing commercially confidential information is a massive administrative drain. �Թϱ��� is tackling this burden by introducing and expanding the integration with Real Life Sciences (RLS) anonymization tools.

Looking further ahead, context-aware AI initiatives with �Թϱ��� Falcon will support SOP-driven automation and interpret evolving confidentiality rules.

Want to keep up with changing disclosure requirements? �Թϱ��� Disclosures is expanding support beyond ClinicalTrials.gov and CTIS to include Japan, the UK, Germany, and China. These improvements help teams manage evolving global requirements from a single, unified ecosystem.

The post Navigating the Post-EU CTR Reality: 5 Takeaways from �Թϱ��� Summit first appeared on �Թϱ��� Systems Europe.

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When I joined my new company, my goal was to streamline regulatory operations and turn our team into a strategic partner for the organization. After successfully transforming regulatory operations at my previous company, I knew that with the right tools, regulatory operations could accelerate innovation and speed therapies to patients.

When I joined, my company had �Թϱ��� Submissions, Submissions Archive, and Registrations. I learned the company’s existing workflows and provided recommendations to streamline end-to-end processes by capitalizing on features built within �Թϱ��� RIM.

The key was to show how regulatory operations can be a strategic asset for the organization, so we needed to understand how to maximize the �Թϱ��� RIM platform when we added �Թϱ��� Submission Publishing. And we wanted to implement it in record-setting time.

Next, I wanted to pressure check the “validation paradigm.” Previously, the team did testing and validation that really didn’t return any benefit, and because �Թϱ��� is a validated environment it was somewhat redundant. So, we adopted a risk-based approach for system changes. This allows the team to automatically adopt upgrades from �Թϱ���’s three releases a year with a streamlined validation process.

“�Թϱ��� Submission Publishing can be a strategic partner to accelerate innovation and speed to patients.”
Matt Neal
Executive Director, Global Regulatory Operations Strategy & Innovation

Getting leadership buy-in

The leadership team and I established a mutual understanding early on to pave the way for these transformational plans. Together, we developed goals and I educated them more deeply on what regulatory operations and the RIM system does today. Then we discussed how it can improve their visibility into what’s happening, and provide valuable data for insight and decision-making.

From that point, I created a plan to show how regulatory operations could be leveraged as a strategic partner to change our submission development process. Because we took the time to define the organization’s needs and align them to our goals, we had leadership’s backing throughout the process.

After successfully implementing �Թϱ��� RIM in a previous company, I was confident in the value we could bring by adjusting our processes. At that company, we were able to spend more time on submission quality versus rote tasks, and submit a breakthrough product Biologics License Application (BLA) faster than expected. Seeing continuous publishing in action for five years at my previous company, I knew we could improve the process here.

Changing the publishing mindset

While we were updating and improving the regulatory operations process, we were always focused on the goal of end-to-end continuous publishing. This meant more productivity and higher quality, as well as reduced stress on the publishing team. I wanted to bring publishing out of the world of heroics, late nights, and weekends and to smooth submissions operations.

I also planned a “team of rivals” style roll-out to help demonstrate the value. One group ran the new process alongside another group running the old process. The goal was to dispel concerns and win them over to the new way of working. I knew that even the skeptics would come around once they saw �Թϱ��� Publishing in action, and sure enough, they all wanted to use the new system when they saw the time savings.

Experiencing a fast and successful implementation

After reconfiguring �Թϱ��� Registrations, Submissions, and Submissions Archive, the regulatory team was ready to implement �Թϱ��� Submissions Publishing. As a company focused on expanding the highest quality oncology therapies to people around the world through “persistent innovation and challenging the status quo,” leadership was behind the plan to move fast.

We implemented Publishing eLearning and used that to self-pace learning alongside the implementation activities with �Թϱ��� and the process exercises. We also loaded a sandbox with our actual documents and data so that the teams could work in a “real world” environment while doing the process exercises. As a result of this “self-guided” approach, conversations with �Թϱ��� became more focused and we were able to quickly execute effective change management, rather than sitting through long educational workshops.

I like to say that it was unique, slightly insane, and incredibly successful. As a result, we implemented �Թϱ��� Submission Publishing in 16 weeks, and I think we could’ve done it faster. �Թϱ��� pushed to keep some live education as a buffer to ensure our success, but the eLearning materials were so thorough that we didn’t even need it.

Outcome: regulatory operations as an asset vs. a cost center

With the backing of senior leadership and my experience with the system, the regulatory operations team successfully implemented the full �Թϱ��� RIM platform to accelerate speed to market. Publishers no longer spend late nights preparing submissions — with continuous publishing, they proactively manage the submission. We now have a single source of truth that acts as the collective memory of the product. The company identified unrealized value within its existing RIM platform by adding �Թϱ��� Submissions Publishing, creating an end-to-end process that transformed regulatory operations into a strategic partner.

About the author:

Matt is an experienced regulatory operations leader with a track record of driving innovation across the pharmaceutical and biotech industries. As executive director of global regulatory operations, strategy and innovation, he leads global initiatives focused on digital transformation, operational excellence, and regulatory modernization. His career spans leadership roles at GSK, Amgen, and Atara, and he was recognized as a �Թϱ��� Hero in Regulatory in 2023. Matt is passionate about advancing regulatory science through technology, collaboration, and bold thinking.

The post Turning Regulatory Ops into a Strategic Partner with Continuous Publishing first appeared on �Թϱ��� Systems Europe.

From streamlining CDMO-sponsor collaboration to accelerating batch release and integrating AI, the key takeaway was that simplifying and standardizing quality processes drives a tangible business impact. As life sciences leaders explore and implement new applications to improve quality in their organizations, the industry is poised for an exciting evolution.

Data as the critical foundation for AI

Quality innovation using AI surfaced repeatedly as a discussion point at this year’s Summit. During the Quality Keynote, we heard from two industry leaders on successful AI strategies for quality.

Magalie Blackie, head of global quality services at Haleon, explained that in a quality context, AI is only as valuable and transformational as the data feeding it, while premature deployment amplifies existing data issues.

Sanofi’s Head of Quality Performance Transformation, Jean-Philippe Francou, recommended that quality leaders focus their AI implementation time and effort on laying a strong data foundation ahead of launch and roll-out across the organization.

“You can’t do anything with AI without quality data. That’s #1.

And to get quality data, you need standardized processes and digital solutions.”
Magalie Blackie
Head of Global Quality Services, Haleon

Magalie Blackie of Haleon and Jean-Philippe Francou of Sanofi
join �Թϱ���’s President of Quality Cloud Mike Jovanis in the Quality Keynote, May 2026.

to hear more AI quality strategy insights.

In a Quality Zone session about solving the right quality management pain points with AI, Novo Nordisk Director Hasse Schøbel reminded us that more data does not automatically equal a ‘better’ AI implementation. Instead, he recommends prioritizing data scope and quality over volume, and applying quality thresholds and controls when data is created so that it can work as an effective AI building block.

Quality leaders now recognize that standardized processes, and having the correct underlying applications, help deliver clean and connected datasets for deeper digital innovation.

Quality Cloud innovations and updates

For a conservative area like quality, understanding how to introduce AI safely and effectively remains a top focus for our customers. During the Quality Keynote, I shared our vision, strategy, and guiding principles for Vault AI. This covered specific agentic Vault AI capabilities we’re introducing and how they will increase efficiency across the board.

Presenting Vault AI’s agentic capabilities in the Quality Keynote

Alongside these AI innovations, the Quality Keynote outlined the broader �Թϱ��� Quality Cloud vision of optimizing and simplifying quality processes for greater efficiency. This includes recent advancements in our core applications, including:

• The new Document Viewer in �Թϱ��� QualityDocs
• Collaborative supplier questionnaires for expanded external collaboration in �Թϱ��� QMS
• How �Թϱ��� Validation Management, �Թϱ��� LIMS, and �Թϱ��� Batch Release reduce time to market

to learn more about new and upcoming Quality Cloud product updates.

How life sciences leaders are modernizing quality

Thirteen �Թϱ��� customers shared their stories at Summit, explaining how modernizing quality management is improving efficiency for their organizations:

• AstraZeneca’s IT Director Paula Haynes shared her organization’s transformation of its validation approach, from using a bespoke tool to adopting Validation Management. It expects to cut cycle times by 20% and reduce event volumes with more right-first-time processes.
• Aenova Group’s VP of Quality Systems Excellence, Letizia Caccialupi, detailed her company’s migration to Quality Cloud. Aenova uses QMS, QualityDocs, and �Թϱ��� Training, and moved from a mixture of highly localized process variations to a single, globally standardized model requiring just 10 SOPs (down from 140 SOPs previously) for the processes implemented in �Թϱ���.
• Sobi’s Petter Gallon, director of global quality systems, outlined why the company’s shift to fully outsourced manufacturing was underpinned by its launch of Batch Release. Sobi now has a single source of truth housing all QA data and supporting automated jurisdictional control, which makes batch release decision-making faster and more accurate than before.

Best practices from quality leaders

Quality leaders from a range of biopharma organizations shared other important insights with peers. Highlights include:

• Novo Nordisk’s Hasse Schøbel recommends maximizing AI impact by serving “the many, not the few” and applying AI to near-universal processes and pain points. Examples of high-impact areas to prioritize include document searching, reporting/trend generation, complaint handling, batch review, and writing/review assistance.
• A discussion group exchanged strategies for modernizing the QC lab, and identified lack of standardization as the biggest barrier to digital uptake in an industry area still largely dominated by paper-based processes.
• UCB’s Nadia Williams, head of IT compliance solutions, identifies digital validation processes as key for maximizing speed and inspection readiness. Nadia shared how UCB’s transition from “scattered” to “centralized” processes with Validation Management cut cycle time by 15%, with the company now targeting a 30% drop in CAPAs and audit actions related to validation.

Celebrating 2026 Quality Heroes

Every year, �Թϱ��� recognizes pioneering customers helping to advance life sciences. Our 2026 Quality Heroes pushed quality to new levels in their organizations, challenging the status quo to deliver better processes and outcomes.

• Strengthening global site collaboration to cut approval times: Birjo Backasch, director of global QA systems at medac, supported the move from fragmented, paper-based legacy systems to a unified platform that drives efficiency and compliance at scale.
• Modernizing quality processes for 9,000+ users across three diverse sectors: Holger Peitz, director of governance framework at Merck KGaA, replaced on-premises legacy systems with a modern, cloud-based quality management system spanning 66 countries.

Quality Heroes celebrated on stage

for more insights from the Quality Zone, including product roadmaps, keynotes, and customer and innovation theater sessions.

The post The Next Era of Quality:
Insights From Industry Leaders at the 2026 R&D and Quality Summit, Europe first appeared on �Թϱ��� Systems Europe.