Moving Beyond Traditional CTMS to Unlock Value in an Outsourced Model

What’s Inside

How does a CTMS Fit into the Future of Clinical Trials? 3

The Evolution of CTMS 3

How did we get to where we are today? 4

The Reality of the Traditional Outsourced Model 5

Creating Actionable Insights from all your Trial Data 7

Are You Future-Ready? 9

Assessing your Operational Data 10

How does a CTMS Fit into the Future of Clinical Trials?

Today, data is being created, exchanged, and collected like never before. It’s embedded in everything we do, whether we’re exchanging information with a friend, planning a trip, or putting a person on the moon. Our world runs on this ever-expanding network of information and, considering global data creation is projected to grow to more than 180 zettabytes by 2025, there are no signs of this trend slowing down.

Clinical data is at the forefront of this data explosion, with the amount of clinical data used per trial increasing by 183% . More data coming from multiple sources feeding into different data systems has made clinical trial management and oversight wildly complex.

The traditional Clinical Trial Management System (CTMS) was designed to view and keep data within the walls of either the sponsor, the Clinical Research Organization (CRO) or data vendors. Historically a CTMS was able to sufficiently handle clinical trial data as there were fewer data sources. However, the proliferation of data sources and the rise of outsourced trials changed how CTMS is defined, and called into question whether they are fit for purpose in today’s world.

How can our industry adapt and maximize the potential benefits of greater data availability? It’s important to first understand the evolution of CTMS and its role in modern-day clinical trials to chart the best path forward for your organization. From there, we can turn an eye toward the future of clinical trial management and oversight and review, scrutinize and define how teams can improve their ability to collect, analyze, and act on operational analytics insights.

The Evolution of CTMS

Before the advent of CTMS, organizations operated in a more manual capacity — with pen, paper, and jampacked spreadsheets. Some organizations still work in this laborious fashion even today. These spreadsheets were used to collect data from monitoring systems, but it didn’t take long for clinical development professionals to recognize they would need a more robust tool. As trials became more complex and more data sources came into play, standardization was a must for organizations looking to efficiently manage clinical trial resources and analyze data from varying systems.

With regulators’ expectations and compliance processes becoming more rigorous, it was clear to most clinical teams that the traditional means of handling clinical trial management were no longer going to cut it.

How did we get to where we are today?

Trial complexity and data volume increasing over time

GAP

BENEFIT

Time consuming Starting somewhere

Lack of data transparency Supplement resource for time-consuming activities

It All Started with Spreadsheets

Siloed

approaches and limited visibility, data ingestion and integration challenges

Ability to track progress of each CRO/partner

CROs and Technology Vendors Emerge to Alleviate Manual Stressors

Changing mindset and challenging status quo

Powerful data, analytics, insights and visualizations

CROs and technology vendors came onto the scene to address the shortcomings of manual spreadsheets and to supplement internal resources. Working to augment the tracking performed by labs and other patient-related data sources, they provided solutions to manage clinical studies. This approach assisted biopharma with data and study management and provided much-needed assistance with things like payment processing, compliance assurance, patient safety and experience, and monitoring.

With the CRO services market expected to grow from $73B in 2022 to $163B by 2029, CROs stand to play an increasingly key role in how clinical trials operate.

Data Ingestion Complexity from Multiple Sources

As sponsor companies began adopting a more outsourced research model, multiple CROs and data providers were brought in to support clinical trials. However, traditional CTMS was designed for collecting site monitoring and milestone data centrally within the walls of either the sponsor or the CRO, they weren’t designed to easily connect with - or ingest data from - other CTMS platforms and data providers. As a result, tracking metrics across a portfolio that leveraged data from varying sources wasn’t easily achievable for many organizations.

Asking clinical trial teams to reconcile reports from various sources, accessing multiple systems, and then replicate that data in their own CTMS hindered organizations from operating at maximum capacity. Instead of adding value to trials and analyzing data for insights, teams were spending more time manually consolidating data and ensuring its accuracy, and in some cases reverting back to managing important data in spreadsheets. This called into question the effectiveness of a traditional CTMS.

3. How it Can Work

Any Data Source

Single Source of Truth

Any Data Consumer

Trials Shift to the Cloud

Today, sponsors and CROs each use an average of eight different applications to support their clinical trial activities. Back in 2018, Tufts Center for the Study of Drug Development (CSDD) reported that increasing focus was placed on EDC, IxRS, eTMF and various drug safety systems, with CTMS in 5th place. Naturally, as organizations have adopted more systems and generated more data, Clinical Trial Management software no longer suffices as a catch-all tool for clinical trial management. This was supported by another survey in 2019 conducted by CenterWatch, which found that 30% of companies were not using CTMS especially when compared to other systems.

In addressing modern-day challenges such as increasing data volume and outsourced research models, a shift to cloud-based systems that provide operational insights have proven to be beneficial for many organizations. A lighter footprint, easier accessibility, and seamless integration all make a cloud-based system extremely compelling to companies aiming to streamline and simplify their trial management and oversight responsibilities. The added benefits are flexibility, scalability and speed of deployment and having near real-time access to all of your data in a single source of truth for actionable insights.

Creating Actionable Insights from all your Trial Data

As it stands today, biopharmaceutical companies are between a rock and a hard place. They know that their CTMS isn’t exactly what they need, but they don’t know how to modify it or what to replace it with. Oftentimes, companies will try to adapt, patch, or modify legacy systems to fit their current needs. The result? Subpar solutions that aren’t fit for purpose, which limit the ability to utilize advances in technology.

Sponsor companies are implementing data strategies and new data management mechanisms to align company-wide demand, governance, and execution. These companies certainly don’t want to go back to spreadsheets or paper, but maintaining their CTMS is becoming more of a burden than a benefit.

Luckily, technology solutions are evolving to meet the needs of the modern-day clinical trial which now provide near real-time actionable insights for all study teams. Let’s dive deeper into the key characteristics these solutions should possess in order to effectively handle your clinical trial data.

Automation, Machine Learning & AI Capabilities

The shift to powerful cloud-based solutions has opened the door for Automation, AI and Cloud-based Analytics capabilities to enable more efficient clinical trials. Through these advances, biopharmaceutical organizations and CROs can get their trials up and running more quickly, in addition to enabling better trial designs, planning, mobilization, execution, and reporting. All of this allows team members to focus on optimizing the trial experience instead of tending to the more tedious tasks.

Additionally, automation capabilities enable greater trial efficiency by reducing the reliance on manual processes. Automating processes such as data input not only reduces the likelihood of human error, but further frees up trial managers to analyze and act on their data.

With the ability to support data reconciliation, mapping, visibility, and accessibility, a cloud-based solution that’s powered by the latest and greatest technologies empowers your teams to accomplish more.

Clinical trial management, monitoring and oversight is critical to your organization’s ability to effectively optimize and deliver trials. Historically, teams have worked in silos independent from one another, which can often lead to duplicative work and operational misalignment.

50% of CROs are still using paper to manage information exchange between systems.

Modern operational insights analytics solutions are built to centralize management, monitoring and oversight to improve study visibility and ensure users are provided with consistent, near real-time actionable analytics. With the ability to act on decisions through a single platform, teams can easily prioritize critical tasks, track enrollment statuses, review open issues, and more, all in one place.

Enabling your users to simplify and streamline their day-to-day workflows by consolidating their disparate systems and tools yields greater efficiencies that bolster clinical trial processes across the board.

Visibility Across All Systems

As biopharmaceutical companies increase the number of technology vendors and CROs, pulling data from multiple sources is a prerequisite. Modern cloud-based clinical trial management and oversight platforms enable an accurate, global, and more complete view of all your clinical trial data. With visibility of the accumulating data from trial planning to study submission, teams can proactively generate actionable insights and mitigate risks from a single source of truth. When you have visibility across all your systems, it’s easier to stay ahead of the curve.

The challenge when working with multiple CROs is that while some of the information is in the sponsors own internal tracking systems, most of the data they get is from their CRO and various other CROs/data vendors.

This information is provided in different volumes, frequency, fields, and formats and requires:

• Logging into the CRO’s CTMS

• Accessing exported PDF reports, PowerPoint slide decks or Excel workbooks

The biggest challenge is how to integrate and interpret all the data provided, irrespective of source and get it into a common representation. This is important for verifying against the clinical trial data and to ensure that current status metrics are correct.

The ultimate goal is to summarise all this data into a common readable format for consumption by internal stakeholders. Once available, teams will have the ability to challenge the CRO when data seems out of date to ensure it is updated.

Flexibility & Scalability

Many organizations are plagued by a dinosaur CTMS solution that isn’t flexible. Trying to patch or modify existing legacy CTMS systems results in more burdensome processes that are not fit for purpose. In today’s world, your technology solutions need to be flexible and scalable in order to accommodate your particular clinical trial needs. This is increasingly important with the increase in adaptive trial designs and more complex trial protocols.

You could implement the most sophisticated solution built on the latest and greatest technologies, but if it isn’t able to grow and evolve alongside your organization, it’ll quickly be rendered obsolete. The best part of a modern future-ready technology solution is it changes with your needs, ensuring you always have the latest and greatest technology as your portfolio grows.

The first step in determining which technology solution is best for your organization is to define your long-term operational goals and expectations. Whether you’re looking to enable improved oversight or fine-tune issue management processes, you must ensure it is configured to meet your needs, today and down the road.

96% of CROs experience significant challenges exchanging data across systems and platforms. Within this survey, (99%) respondents report the need to unify clinical applications to achieve better visibility and oversight (70%), faster trials (63%), and easier stakeholder collaboration (61%). Additionally, (95%) cite the need to improve the use of CTMS in clinical operations. Top drivers are improved reporting (68%), increased visibility (60%), and more proactive risk mitigation (58%).

Acting on a Single Source of Truth

Notice a common theme around the importance of centralizing and consolidating your systems? Modern cloud-based clinical trial management and oversight solutions take into account the numerous data systems and tools in any given organization’s tech stack and work to combine all that data into a single source of truth. When there’s no dispute around data integrity or versioning, teams can operate confidently knowing their work is completely accurate.

Working from a single data platform - from ingestion through insights - ensures study submissions are always justifiable and traceable. Through a single source of truth, teams can more easily access near realtime operational data to efficiently optimize trials, provide actionable insights to manage risks, provide timely updates to stakeholders, and quickly draw impactful conclusions.

Remove the need to maintain siloed repositories for your clinical and operational data and utilize a modern, cloud-based solution to leverage all data across all systems.

Are You Future-Ready?

Clinical trials and the technology they run on have evolved rapidly in a short period of time. For CROs, the bar has been raised for client expectations around operational insights, data currency and visibility, and predictive analytics – and even prescriptive analytics. To adequately accommodate biopharmaceutical companies’ shift to prioritizing their core competencies, CROs need to embrace the interoperability of clinical and operational data and turn it into an asset for their clients.

As previously mentioned, traditional CTMSs were designed for keeping data within the walls of either the sponsor, the CRO, or the data provider. Today, as biopharmaceutical companies continue to generate more data and a need to ensure robust oversight, CROs and data providers need to better own their operational data by utilizing clinical trial management and oversight solutions that are built with the current times in mind. In the modern world, applying the latest technologies and leaning on future-ready solutions isn’t just a nice-to-have— it’s a necessity.

Operational data comprises a wealth of valuable details that are vital for effective planning and management of clinical trial processes across numerous functional units, including but not limited to: Medical Affairs, Clinical Operations, Study Drug Supplies, Regulatory Affairs, Biostatistics, Data Management, and Medical Writing. It is imperative that the entire organization has access to one reliable source of the truth. At its core, eClinical’s elluminate Operational Insights is designed, as the name implies, to provide insights driven by operational details for effective oversight and management of clinical trials.

Going forward, sponsors and CROs should look to establish a cloud-based clinical trial management and oversight solution within the framework of a clinical data platform — like eClinical’s elluminate® Operational Insights. At its core, Operational Insights is designed, as the name implies, to provide insights driven by operational details for effective oversight and management of clinical trials. By centralizing disparate data systems, they can modernize and automate their digital data flows, all the way from collection through submission. This also takes into consideration agile or hybrid clinical trials where data collection may differ from site to site, or country to country, requiring a cloud-based solution that is adaptable for this variation of data ingestion and visualization at scale. In turn, this enables sponsors and CROs to move beyond their current data challenges and focus on optimizing their clinical trials to produce the highest-quality study submissions.

In the face of growing data streams and sources, increasingly outsourced CRO models, and agile or hybrid trials, biopharmaceutical companies face an uphill battle to streamline operational workflows. In order to empower teams to do their best work, sponsors and CROs will need to shape the future of clinical research by adopting flexible and scalable cloud-based solutions that can easily adapt and evolve for changing needs and put them in the driver’s seat of their clinical trials.

1 Clinical Data Volume and Diversity Pose Increasing Challenges and Delays”; Tufts Center for the Study of Drug Development (CSDD); Impact Report; Jan/Feb 2018, Vol. 20 No. 1z

2 Unified Clinical Operations Survey Report; Veeva; June 2019

Assessing your Operational Data

Questions to Ask:

• Do you own your operational data? Can you use it for future studies?

• How is data integrity governed?

• How is the data integrated from multiple applications and sources?

• Is there near real-time transparency of data, irrespective of source?

• How are actionable data insights generated for various line functions?

Contact eClinical today, so we can help you access your operational data needs and determine your future-readiness.

About eClinical Solutions

eClinical Solutions helps life sciences organizations around the world accelerate their digital clinical initiatives. Our intelligent clinical data platform and data services give our clients real-time, self-service access to all their data from one centralized location; plus advanced analytics that help them make smarter, faster business decisions.

T: 877-355-8668 (877-ELLUMN8) eclinicalsol.com

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