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Clinical trials have become increasingly complex, sophisticated, and large, which has increased the requirement for specialized knowledge that frequently spans multiple countries and the necessity for flexible staffing. Consequently, there have been notable changes in clinical operations staffing in the last few years. The trend has shifted from relying on direct internal hires, to using contracting agencies and independent contractors to fill staffing gaps, to leverage contract research organizations (CRO).
Functional service provider (FSP) outsourcing of clinical operations services has become increasingly popular in recent years due to sponsors’ need to broaden their resource allocation flexibility and gain access to a quality global talent pool with the necessary depth and breadth of knowledge.
A strategic balance between knowledge, cost, risk, flexibility, reliability, and continuity must be established when deciding whether to use internal hiring, outsource through independent contractors or staffing agencies, or build partnerships with CROs. All these elements ultimately impact the sponsor’s capacity to make investments and grow their portfolios.
At Maxis Clinical Sciences, we understand that every trial is unique. That’s why we offer a range of FSP models, from flexible hybrid teams to fully managed solutions, all designed to fit the specific needs of each sponsor. We also combine our expertise with smart technology—such as data management tools and AI-driven workflow solutions—to help teams work more efficiently and stay ahead of challenges.
In this blog, we’ll take a closer look at how FSP models are evolving, what makes a great partnership, and how technology is transforming clinical operations to keep pace with today’s fast-changing research landscape.
For more than 20 years, the FSP model has been utilized within the clinical research sector, initially to assist with specific clinical operations and data administration activities. Today’s models, however, are increasingly providing features tailored to sponsors’ requirements to adapt with shifting outsourcing trends. As per industry reports, the global FSP market is estimated to be worth approximately USD 18.4 billion in 2025, with projections to grow to USD 32.8 billion by 20321. This market is expanding at a compound annual growth rate (CAGR) of around 7.2% from 2019 to 2033, fueled by increasing clinical trial complexity and the rising demand for specialized expertise2. Specifically, the FSP Clinical Research Organization segment is forecasted to reach about USD 14.65 billion in 2025, maintaining a similar CAGR of 7.2% through 20332. Key growth drivers include the growing complexity of clinical trials, higher outsourcing demand, and technological advances such as artificial intelligence and machine learning.
FSP CROs are becoming more popular with sponsors for several reasons:
• They help save money and make processes more efficient.
• They offer flexible staffing that gives sponsors better control over their data.
• They provide access to specialized skills that aren’t always available in-house.
• They allow sponsors to focus more on using new technologies.
• They help keep strong relationships with clinical sites.
In the mid-2000s, sponsors became interested in FSPs because of their flexibility. But back then, many companies weren’t ready to make these partnerships work well, so the industry went back to full-service outsourcing. Since then, FSP models have improved a lot. Now, they offer pricing based on units, better management, and more use of remote teams.
Today’s FSPs also integrate advanced technology like artificial intelligence, electronic data capture, and remote monitoring. These tools help speed up data collection, improve data quality, and allow real-time oversight of clinical trials. By using smart technology alongside skilled staff, FSPs help sponsors run clinical trials faster, more efficiently, and with better control.
Now, sponsors can choose from full-service CROs, FSP models, or a mix of both, depending on what fits their needs best.
With these evolving models and technologies in place, it’s important to understand what makes a great partnership and how technology is reshaping clinical operations to keep pace with today’s fast-changing research landscape.
The success of any clinical trial depends heavily on the quality and dedication of the people running it day to day—clinical data managers, clinical research associates (CRAs), clinical trial coordinators (CTCs), and other clinical operations staff. These front-line professionals play a vital role in monitoring trials, preventing protocol violations, ensuring data quality, and safeguarding patient safety. Their work helps avoid delays and serious issues.
In an FSP model, these team members often stay involved throughout the entire study. This continuity preserves valuable knowledge and builds strong relationships with trial sites, which reduces the need for repeated training and minimizes disruptions.
When selecting an FSP partner, sponsors should ask about their hiring and training practices. Do they emphasize both technical expertise and communication skills? Do they provide ongoing training that adapts to changing trial requirements?
For example, Maxis Clinical Sciences invests in continuous staff development and supports clinical teams with digital platforms and conversational AI assistants. This combination helps staff stay current with protocols, handle routine tasks efficiently, and maintain strong site relationships throughout the trial.
Keeping staff long-term is crucial. Experienced teams foster better communication with sites, which helps trials run more smoothly. Plus, strong clinical management ensures consistent quality and lightens the sponsor’s oversight responsibilities.
Conducting clinical trials in different countries involves more than just having a population spread across geographies. It demands a deep understanding of local regulations, customs, languages, and healthcare systems.
Top FSP providers blend centralized coordination with local teams who know their regions inside and out. This approach accelerates site activation, boosts patient recruitment, and ensures compliance with country-specific rules.
For example, by using tech-enabled systems and automated AI support tools, FSPs can deliver real-time reminders and compliance tips to site staff in their native language. This helps reduce errors and improve data quality worldwide.
By combining local knowledge with centralized control, sponsors can run complex global trials efficiently without sacrificing quality or oversight.
FSPs no longer view technology as an auxiliary; rather, it is foundational to the management of clinical operations today. Using data management tools, workflow optimization, intelligent virtual assistants, and advanced analytics, FSPs can simplify processes, reduce errors, and provide sponsors with timely insights.
For example:
By bringing these technologies into daily operations, FSPs improve efficiency and data quality, allowing clinical teams to focus on the most important parts of managing the trial.
When sponsors entrust critical clinical tasks to an FSP partner, clear governance and accountability become essential. Good governance means transparency, clear expectations, and a collaborative approach where both parties share responsibility for delivering high-quality, on-time trials.
Successful FSP partnerships are built on jointly developed plans that define roles, responsibilities, and success measures. This shared framework encourages open communication, enabling sponsors to maintain strategic oversight while the FSP manages day-to-day operations.
For example, Maxis Clinical Sciences leverages advanced technology platforms that offer real-time visibility into trial progress, data quality, and potential risks. This enables sponsors to quickly spot and resolve issues before they affect study timelines or compromise data integrity.
Dedicated clinical operations managers oversee quality and compliance across all regions, ensuring consistent standards and reducing the sponsor’s oversight burden. AI-powered site support systems also support site staff with real-time protocol guidance and audit readiness reminders, helping minimize deviations and keep teams engaged.
Strong governance goes beyond checklists—it’s about building a culture of trust, transparency, and shared goals. This partnership mindset gives sponsors confidence that their FSP understands their priorities and is prepared to handle challenges proactively.
The clinical trial landscape is quickly moving toward decentralized and hybrid models to improve patient access, diversity, and efficiency. These approaches combine traditional site visits with remote monitoring, telemedicine, and digital data collection, which adds new challenges.
Sponsors need FSP partners who are flexible and comfortable with technology, able to support both onsite and remote activities while maintaining compliance, data quality, and patient engagement.
To meet these needs, FSPs use advanced web-based tools like interactive AI platforms that provide real-time support to site staff, whether on-site or remote, helping reduce errors and keep trials on track. AI-powered data monitoring platforms continuously check data quality and spot issues from various sources, including wearables and patient reports.
Integrated communication systems connect sponsors, sites, and patients, enabling better engagement and faster problem-solving. By combining these technologies, FSPs help sponsors manage decentralized and hybrid trials more efficiently while enhancing patient experience and data integrity.
Finding the right partners who can keep up with the growing demands of clinical trials is essential for sponsors today. FSP models have become an important way for sponsors to access experienced professionals and resources that can adjust as the trial progresses.
Strong FSP partnerships rely on knowledgeable teams, a global reach combined with local understanding, effective use of technology, clear management, and the ability to support new trial methods like decentralized and hybrid approaches.
As trials focus more on patients and gather more data, having flexible partners who use the right tools will become even more important. Sponsors who work with providers combining expertise and practical solutions will be better able to speed up trials, control costs, and maintain data quality.
In short, FSP partnerships are more than just outsourcing, they are true collaborations that help sponsors confidently handle today’s complex clinical research and achieve meaningful results.
