Zelta

Trends for 2026: Targeted AI, continuous trials, and navigating uncertainty

Jennifer Duff — Wed, 04 Feb 2026 21:30:46 GMT

The 2026 clinical trial trends at a glance:

The adoption of AI-driven protocol automation and risk-based validation will significantly reduce manual processes, accelerate timelines and enhance data quality.
Evolving regulatory requirements will demand clinical research teams to increase agility across processes and technology.
Strategic differentiation will be essential for CROs to stay competitive and deliver value.

As the clinical trial industry faces key challenges such as shifts, rising costs, and staffing challenges, 2026 is poised to be a pivotal year for teams to find efficiencies through modernizing study processes.

How CDMS support services can make or break complex study rescues

Kofi Darkoh — Thu, 09 Oct 2025 19:16:31 GMT

A version of this story originally appeared on Pharmaceutical Technology.

The story at a glance

Fractyl Health had to rescue a complex Phase II trial that had changed hands multiple times and faced a number of difficulties.
Zelta provided a CDMS solution and 24/7 support service that made it possible to quickly build a new clinical study database, add modules on demand, and do it all in just four weeks.

As clinical trials grow more complex, the ability to rescue a struggling study hinges not just on technology, but on the strength of your CDMS partner’s support services. When timelines are tight and data integrity is at risk, having a clinical data management platform with responsive, expert support can mean the difference between failure and recovery.

The 24-hour study build is the future of clinical data management

Jennifer Duff — Mon, 15 Sep 2025 13:00:00 GMT

The clinical development landscape is on the brink of a significant transformation. Generative artificial intelligence (GenAI) is poised to unlock between $13 billion and $25 billion in annual value for pharmaceutical clinical development, signaling a shift from outdated, manual processes.

How ICH E6 (R3) is changing clinical trials

Jennifer Duff — Mon, 08 Sep 2025 13:28:26 GMT

This piece originally appeared on Pharmaceutical Technology.

As clinical trials become more complex, the ICH E6 (R3) updates emphasize smarter monitoring, greater participant focus, and a stronger role for technology. We explore the latest Good Clinical Practice guidelines and what they mean for sponsors, CROs, and tech vendors.

The latest ICH E6 (R3) guidelines could transform how clinical studies are built and operated.

The updated ICH E6 (R3) guidelines introduce a range of critical changes aimed at modernizing clinical trials. These updates refine the way trials are designed and executed, with a focus on the increasingly vital role that technology plays in ensuring compliance, data integrity, and patient-centric outcomes.

The updates to guidelines were reorganized into a principles and objectives section, with Annex 1 (interventional trials) coming into legal effect on July 23 2025 and Annex 2 (guidance on decentralized trials and real-world data) expected to be finalized later in the year.

“What the updated guidelines are really trying to do is put more encouragement around adopting risk-based practices,” explains Isaac Erickson, vice-president of consulting services at Zelta. “For eCOA and ePRO, they’ve made some pretty major changes to data privacy – and also some changes to how we’re expected to collect data remotely.”

Here’s what CROs and sponsors need to know about these updated guidelines for their clinical trials.

What are the key updates in ICH E6 (R3)?

Central to the updated guidelines is Quality by Design (QbD), ensuring that quality is proactively embedded into the clinical trial’s architecture from the beginning to significantly improve efficiency and reduce costly reworks.

Another cornerstone of the ICH E6 (R3) update is patient-centricity. Enhanced participant engagement is now being explicitly encouraged through technologies such as wearables and virtual healthcare tools.

Previously, risk-based quality monitoring (RBQM) was adopted inconsistently across the industry. The updated ICH E6 guidelines mandate a systematic approach to risk management, providing explicit strategies to identify, evaluate, and mitigate potential risks proactively. According to ACRO’s 2025 RBQM survey, 96% of trials now include at least one RBQM component (vs just 53% in 2019), with centralized monitoring and remote oversight becoming standard practice¹. The survey also found that while Source Data Verification (SDV) is being significantly reduced, Source Data Review (SDR) remains prevalent, often serving as a comfort layer when centralized monitoring is in place².

Despite this progress, a surprising number of trials still rely on 100% SDV and SDR, highlighting room for further optimization.

The updates also elevate the role of data governance and integrity, requiring robust compliance mechanisms and confidentiality protections. Detailed audit trails are now essential, requiring complete traceability of every data point and action taken within trial systems.

“Technology can outpace governance very, very quickly,” adds Erickson. “So, I think this was a needed update.”

The role of CDMS platforms in ICH E6 (R3) compliance

Clinical data management software is critical to complying with these updated standards, with integrated CDMS platforms now providing comprehensive solutions supporting QbD, RBQM, and patient-centric objectives.

By integrating eConsent, patient-reported outcomes, risk-based monitoring, and audit trails into a single unified platform, these capabilities can significantly simplify trial management.

Integrated CDMS solutions also facilitate smoother communication and coordination between stakeholders, enabling faster, data-driven decision-making – all increasingly crucial for maintaining oversight and regulatory compliance.

For sponsors and CROs, the updated ICH E6 guidelines mean greater operational efficiency, reduced costs, and better data-driven decision-making.

“When systems work together from the start, trials run more smoothly. It’s not just about efficiency, it’s about creating space for better decisions and better outcomes,” says Walker Bradham, senior director of product management and design at Zelta.

Participants also see significant benefits from these platforms, with digital engagement tools reducing participation barriers, enhancing accessibility, and improving the overall trial experience. With fewer site visits required and more efficient remote data collection, participants experience reduced inconvenience and greater satisfaction.

“Technology like wearables and ePRO makes trials more humane; it meets people where they are,” Bradham notes. “And with AI and real-time data, we’re not just reacting to problems, we’re staying ahead of them.”

The updates also support trial sites by simplifying data collection and reducing administrative burdens, enabling clinical staff to focus more directly on participant care and data analysis. Consequently, stakeholders at all levels – including participants, trial sponsors, CROs, and sites – can experience a more cohesive and efficient clinical trial environment.

Zelta’s alignment with ICH E6 (R3) 

Clinical data management platforms such as Zelta Electronic Data Capture exemplify the ICH E6 (R3) vision of proactive quality integration, enabling sponsors and CROs to seamlessly incorporate quality into the trial design from the beginning.

“Platforms like Zelta allow organizations to build trials around the tools from the outset, streamlining complex trial builds with flexibility, reusability, and ease of use,” adds Erickson. 

Zelta is a cloud-based eClinical platform that boosts engagement and retention in clinical trials by offering flexible purpose-built tools, ensuring sites and participants stay informed and involved through the trial. Its built-in eConsent and ePRO capabilities support more accessible and transparent participation. Real-time support features such as instant chat quickly address participant and site questions, enhancing confidence and trust. And regular feedback loops help participants feel valued.

Zelta’s real-time reporting and analytics align closely with the ICH E6 (R3) emphasis on proactive, risk-based monitoring. By identifying issues as they arise, the platform supports faster, more informed responses, ensuring that trials remain compliant, efficient, and aligned with regulatory expectations.

Furthermore, Zelta’s data governance system provides a unified experience across CDMS, ePRO/eCOA, and RTMS to significantly simplify clinical data management. Having all clinical data consolidated in one system doesn’t just reduce trial complexity, it also enhances ICH E6 compliance.

Beyond just meeting the requirements of today’s ICH E6 guidelines, the Zelta platform’s capabilities are designed to anticipate future trends in clinical trial design.

“The next five years will see greater adoption of hybrid and decentralized trials, enhanced by real-time monitoring and refined patient-centric designs,” predicts Bradham. “And these are all factors we take into consideration with each update made to our platform.”

For sponsors and CROs aiming to stay competitive, embracing a CDMS platform like Zelta’s that is ahead of the game on both these capabilities and ICH E6 guidance is essential for achieving supporting regulatory compliance, risk management, and optimal trial outcomes.

References:

To learn more about how Zelta can support CROs and sponsors, download our report  Confidence in clinical trials amid complexity and change.

FSO vs FSP: One CRO highlights key considerations for your decision

Jennifer Duff — Fri, 18 Jul 2025 21:15:09 GMT

This piece originally appeared on Pharmaceutical Technology.

As the complexities of clinical trial data management ramp up, traditional outsourcing models are changing.

Zelta success stories: Streamlining clinical data collection, adding ePRO to EDC, and multi-point clinical data management

Jennifer Duff — Thu, 12 Jun 2025 13:00:01 GMT

We recently wrapped on our 3^rd annual Zelta User Conference. We had a fantastic two days in Chicago, packed with insightful panel discussions, tantalizing previews of our product roadmap for 2025 and beyond, and most importantly, some inspiring success stories of how Zelta users are leveraging the platform to transform their clinical trials and drive bold research. If you couldn’t make it this year, here are three of those user success stories you missed.

Platform trials: How to maximize results with an EDC platform

Jennifer Duff — Wed, 14 May 2025 13:20:43 GMT

This piece originally appeared on Pharmaceutical Technology.

As clinical research continues evolving to become more innovative and efficient, adaptive trials, specifically platform trials, are leading the charge.

Platform trials enable the simultaneous study of multiple treatments against a signal control group within the same overall trial structure. Inherently adaptive, platform trials can be modified to add or drop treatments over time based on interim results, making them a more efficient and flexible option compared with standard clinical trial models.

This multifaceted approach allows researchers to evaluate different therapies for a single disease at the same time, offering useful opportunities for comparison and contrast.

The race to find effective therapies for Covid-19 created a spike in popularity for platform trials, with the most in 2020 and 2021 according to GlobalData’s Clinical Trials Database. While 2022 saw a reduction of 53% in adaptive trials, they rebounded by 75% in 2023 to almost match pandemic levels, indicating there is still ongoing interest in this clinical trial method beyond the pandemic.

Because platform trials can test a combination of therapies, there is greater potential for participants to be randomized in an active treatment arm and, consequently, receive additional benefits. This can lead to enhanced engagement from participants and fewer dropping out of the study.

But while platform trials have the potential to be more effective and less expensive than traditional trials, challenges remain concerning data management. Integrated cloud-based electronic data capture (EDC) solutions are providing clinicians with the tools they need to harness the full potential of platform trial benefits.

This article explores the benefits of adaptive trials and how unified EDC platforms can best leverage these benefits to overcome complex study builds.

Platform trials explained

Adaptive trials, including platform trials, are clinical studies designed for flexibility, allowing certain aspects of the trial to be modified as data is collected. Unlike traditional trials that follow a fixed protocol, adaptive trials can introduce changes such as adjusting doses, adding or dropping treatment arms, or modifying sample sizes.

With platform trials, the goal is to design a master protocol that outlines the common elements of the trial which will remain constant along with the mechanisms that allow for adaptation. This approach maximizes the utility of the trial, ensuring resources are allocated efficiently and offers the promise of a better experience for its participant.

Adaptive trials are increasingly being used across all phases of clinical trials. Out of the adaptive trials recorded by GlobalData running globally since 2015, the most were in Phase II at 45.6%, followed by 38% in Phase I-II.

According to GlobalData intelligence, oncology has been the dominant field for platform trials since 2015. This trend did not change in the peak pandemic years of 2020 and 2021.

“In platform trials, it’s essential to adapt based on how participants respond to treatments,” explains Bradham. “This requires incorporating specific measurement criteria into the protocol, such as biomarkers, additional treatment cycles, or adjusted treatment combinations. The principles of precision medicine align well with this approach, allowing platform trials to be designed with flexibility from the outset.”

Platform trials help consolidate resources, reduce inefficiencies, improve patient experience

A major source of inefficiency in clinical trials is that multiple therapies and sponsors are often involved in separate trials in the same therapeutic area. Platform trials provide a key advantage on this front, by combining findings from multiple studies to improve outcomes for stakeholders.

This function also extends to combining resources to reduce operational inefficiencies in how the trial is conducted. Processes can be taken under one umbrella, from designing a unifying protocol to recruiting sites and participants. By spreading tasks across different stakeholders, platform trials reduce costs and minimize challenges such as finding patients, maintaining the control group, and regulatory burdens.

”Running individual trials can be costly for sponsors and biotechs,” notes Bradham. “Platform trials offer a more efficient solution, enabling CROs to conduct trials effectively, optimize resources, and ultimately pass cost savings back to the sponsors and biotechs.”

Beyond just consolidating resources and reducing cost inefficiencies for the sponsors and biotechs running the study, platform trials can also improve the experience for patients. Some patients participate in trials because they are looking for an alternative to standard care, and can end up disappointed when that expectation is not followed through on.

However, in a platform trial where multiple therapies are being tested, the likelihood of participants being randomized into one of the active treatment arms is higher. The benefits for study participants are therefore greater, resulting in improved patient engagement and lower study dropout rates.

A real-world case study of adaptive trials

A leader in the EDC space, Zelta by Merative is a cloud-based unified data management system and acquisition platform with customizable modules. Zelta’s functionalities can be tailored to support even the most complex clinical trial demands, including platform trials.

During the pandemic, Zelta partnered with several trials investigating therapies for Covid-19. One platform study included four different treatment arms in three countries and 30,000 study participants over two and a half years. In a trial of this scale and complexity, flexibility was paramount to ensure success.

More than 20 post-go-live changes were implemented through the Zelta platform in the study. Ordinarily, making one post-go-live change to a trial model can take days to update and lead to downtime in data collection. However, with Zelta, the timeframe for implementing updates is shortened substantially.

“On average, it took about 18 minutes to implement these changes, significantly reducing the disruption to data collection,” adds Bradham. “Typically, deploying post-go-live changes can take days, during which the system is offline, preventing data collection, report generation, and analysis.

“This efficiency is crucial when managing tens of thousands of participants. Otherwise, sites face the additional burden of maintaining data and coordinating its entry once the system is back online. According to a study by the Tufts Center for the Study of Drug Development, each mid-study update can add approximately 30 days to clinical trial timelines.”

How Zelta supports adaptive trials

The efficiency of the Zelta platform helped expedite timelines in the critical race to better manage the extra demands from the Covid-19 pandemic.

“In a platform trial, when you have different sponsors and stakeholders, having a cloud-based solution can dramatically simplify that, and take a lot variables and vendor management off the table,” says Bradham.

In the Zelta platform, all data is available without needing to be integrated or programmed separately to involve different teams or vendors. By hosting randomization and trial supply management, medical coding, and lab management on a singular platform, Zelta can help simplify the platform trials process.

From a proprietary perspective, Zelta can also separate data from different sponsors and biotechs into their datasets to ensure information is being correctly extracted and received by the right personnel.

Offering a unified approach to digital clinical trial management and enhancing data accessibility, Zelta is a high-performing, adaptable solution that can streamline even the most complex clinical trials.

See it for yourself: unlock your own interactive Zelta demo.

Zelta user success stories: Less stress, lower database costs, and fast-tracked clinical trials

Jennifer Duff — Wed, 12 Mar 2025 21:08:19 GMT

We’re profiling another selection of CROs and pharma companies using Zelta. Check out their success stories of how they’ve used the platform to create less stress, lower database costs, and fast-tracked clinical trials.

How supervised machine learning optimizes AI use in clinical trials

Walker Bradham — Wed, 12 Feb 2025 15:39:34 GMT

Artificial intelligence (AI) is widely considered to be the technology that will offer the most benefits for clinical trials. In GlobalData’s State of the Biopharmaceutical Industry annual survey to pharma professionals, AI came out on top for tech with the greatest sector impact in the consecutive years of 2020-2023. But which type of AI holds the most promise?

Clinical trial trends in 2025: Investment headwinds, wearables, and targeted AI uses

Jennifer Duff — Wed, 29 Jan 2025 14:00:00 GMT

This article originally appeared on Pharmaceutical Technology.

2025 is set to be another significant year for clinical trials. According to GlobalData’s Clinical Trials database, as of January 2025, there are 3,213 trials planned to start this year – including 823 in Phase I and 1,102 in Phase II. As with 2024, oncology is expected to remain the top therapeutic area, accounting for 946 trials, followed by central nervous system with 686 trials, then cardiovascular some way behind with 258 trials.