The last decade has seen a significant increase in data-focused and online technologies used in clinical trials, adding to the greater number of complexities in the field that must be carefully navigated by contract resource organizations (CROs).
Between 2014 and 2024, GlobalData recorded a 76% increase in new clinical trials using web-based technologies. Over the same period, there was a similarly notable 75% rise in trials that used electronic data collection identified by GlobalData 鈥� and these trials have increased in complexity, volume and velocity.
To meet growing demands amid an increasingly challenging industry landscape, a critical decision for a CRO is to ensure effective clinical data management at the outset of the trial. That means making a choice between either full-service outsourcing (FSO), functional service provider (FSP), or specialized outsourcing solutions.
In this article, we speak with Santie Britz, senior data team lead from MMS Holdings, a leading CRO with over 20 years of expertise in guiding sponsors through data services and regulatory submissions. Discussing why the company鈥檚 specialized functional outsourcing approach can benefit sponsors, Britz also details how working with the right tech partners has made a major difference in supporting the clinical data management needs of MMS鈥� clients.
FSO vs FSP: what鈥檚 the difference?
Until recently, the choice of full-service outsourcing (FSO) vs functional service partnerships (FSP) most frequently was dominated by the former. In an FSO model, sponsors typically contract the delivery of an entire clinical trial to a single CRO or, at best, a clinical-focused CRO partnering with a data-focused CRO such as MMS.
But while this approach offers a single point of accountability, it lacks flexibility. Now as clinical trials and data management become more complicated endeavors, sponsors are increasingly gravitating toward FSP, hybrid, and specialized outsourcing models, which offer greater 鈥� and needed 鈥� adaptability and efficiency, allowing sponsors to use a 鈥榖est of breed鈥� approach and select partners based on their core competencies.
MMS Holdings goes beyond the traditional definition of an FSP, assuming full responsibility for the full data lifecycle of a clinical study, from trial design to submission, and working in a variety of models including study-based and FTE-based approaches.
鈥淲e ensure data integrity and compliance from the outset,鈥� explains Britz. 鈥淲e have control from the beginning to the end. We feel that sponsors are increasingly choosing this specialized, data-focused outsourcing approach, especially where the data is growing exponentially, but the complexity of these studies is different.鈥�
One key difference between FSP and FSO partnerships is flexibility. The full-service CRO might have its own proprietary systems, including frameworks, programming languages, and tools. With an FSP model, a sponsor has more say in what they want from the start. The study鈥檚 needs are clearly defined by partner relationships and technical capabilities.
Sponsors may have their own internal platforms they wish to use, or they might be open to collaborating with their CRO. Although MMS supports sponsors who already have a preferred electronic data capture (EDC) provider, they鈥檙e more apt to recommend platforms that they already have experience and proven success with, such as Zelta by Merative.
Leveraging the right partners to maximize an FSP model
Using Zelta, MMS has been able to accelerate trial cycle times from database setup through to database lock.
鈥淭he Zelta platform aligns well with our ability to support sponsors of all sizes and means we can be adaptable across all study phases,鈥� says Britz. 鈥淲e can support our clients and provide them with a good solution even through early pivotal trials and be submission-ready across the entire development lifecycle.鈥�
Britz also cites Zelta鈥檚 intuitive interface as a key decision point for using the platform. The automated dashboard has helped reduce staff training times. The efficiencies created also enable the CRO to dedicate more resources to focusing on data quality and enhancing value, rather than losing time navigating the system 鈥� all of which has paid dividends in delivering new cost and time savings.
鈥淥ne big advantage Zelta offers us is that the platform doesn鈥檛 need to be down in order to implement post-production changes,鈥� adds Britz. 鈥淪o these enhancements can be made without disrupting any trials in progress.鈥�
鈥淥ne big advantage Zelta offers us is that the platform doesn鈥檛 need to be down in order to implement post-production changes. So, these enhancements can be made without disrupting any trials in progress.鈥�
Santie Britz, senior data team lead from MMS Holdings.
Alongside optimizing timetables, this function ensures study continuity is not compromised and gives CROs the flexibility they need to accommodate the needs of the study and sponsor. This allows MMS to maintain standards and be submission-ready across the entire development lifecycle.
Creating a single source of truth
From an FSP perspective, Zelta differentiates itself from its competitors by centralizing data into a single EDC.
鈥淲e like to have one single source of the truth,鈥� says Britz. 鈥淲hen everything is combined into one platform, it makes our work much easier. It simplifies our visualization of the study and eliminates the need for multiple disconnected systems.鈥�
This in turn reduces admin costs and data management resources. Features such as Zelta鈥檚 built-in medical coding further help productivity by making coded data immediately visible to everyone. This also gives the sponsor greater oversight and makes it easier to foster collaboration between different partners in the study, encouraging more streamlined decision-making.
And by incorporating a use-only-what-you-need array of customizable modules 鈥� such as ePRO or medical coding with AI 鈥� CROs, in turn, have more control over what they can offer sponsors.
Delivering smooth database locks
Database locks can be a significant and lengthy obstacle to finishing a study. Britz describes the final lock with Zelta as 鈥渙ne of the easiest database locks I鈥檝e done鈥�.
鈥淲ith Zelta, you have lots of audit reports in place that you can continually check and, at the end, press a button,鈥� she says. 鈥淣o downtime, no nothing. So, that part is also seamless.鈥�
Clinical data management is only getting more complex. Each study has its own unique needs, the investments needed to start trials are becoming more costly, and the landscape for running new studies faces a lot of sudden instability. Zelta offers an adaptable, user-friendly FSP or specialized outsourcing approach for CROs and sponsors looking for more control and confidence in their studies.
To learn more about how Zelta can support CROs and sponsors, download the report below.
