A practical route through regulatory uncertainty in clinical trials

Regulatory uncertainty has become a defining feature of modern clinical development. Requirements evolve quickly: guidance is updated or reinterpreted, and trial designs themselves are shifting through decentralised approaches, hybrid decentralised clinical trial (DCT) models, and a growing reliance on real-world data and digital endpoints. Clients must not only stay compliant – they must make timely, informed decisions across multiple regions, from North America and Europe to Asia-Pacific, where local rules, timelines, and authority expectations vary.

Protocols have become more complex, with phase III clinical trials now taking 11% longer (1,247 vs 1,382 days), containing 30% more endpoints, 61% more procedures, 68% more countries, and 56% more investigative sites compared to a decade ago.¹ At the same time, protocols now generate an average of 5.9 million datapoints, increasing 11% annually since 2020,² while the cost of developing a new drug has risen 65% over the past decade, from $1.3bn to $2.2bn.³

For sponsors, the challenge is clear: staying compliant isn’t enough. Organisations must remain agile and decisive across global portfolios, anticipating regulatory changes before they create delays.

One of the most effective strategies is partnering with a Functional Service Provider (FSP). FSP partners provide embedded, specialised expertise across areas including regulatory affairs (RA), clinical operations, medical writing, and pharmacovigilance (PV), delivering consistent, high-quality support. When implemented well, an FSP partner moves sponsors from reactive “firefighting” to proactive, streamlined execution – tracking regulatory shifts, interpreting regional implications, and updating deliverables before uncertainty translates into costly delays.

Why the FSP model fits today’s environment

Traditional internal teams often struggle to manage volatility across complex, global trial portfolios. Workloads spike unpredictably around regulatory updates, manufacturing changes, or safety signals, creating bottlenecks that slow approvals and stretch resources thin.

FSP models address these challenges by providing additional support through dedicated, scalable teams that integrate seamlessly into the sponsor’s systems and processes. In RA, FSP teams can handle routine but critical lifecycle activities, reducing bottlenecks and driving efficiency across multinational portfolios. Against this backdrop, managing regulatory uncertainty effectively requires more than predicting what regulators might request; it demands the ability to respond rapidly, maintain consistency, and uphold quality across regions.

Proactive regulatory monitoring that reduces approval delays

Strong FSP partners act as regulatory intelligence engines. Teams continuously monitor regional and global updates, interpret practical implications, and translate insights into action for ongoing programmes.

This proactive monitoring reduces the risk of late-cycle rework, missed local requirements, or submission inconsistencies that trigger avoidable questions from health authorities. The stakes are high, and poor oversight can lead to costly delays and reputational harm. Clients need teams that can quickly and proactively monitor, expertly interpret, and apply regulatory intelligence to make timely recommendations.

Many FSP partners maintain structured regulatory intelligence systems that consolidate country-specific rules, timelines, and procedural guidance. The goal is not the tool itself, but to make regulatory knowledge easily accessible, current, and integrated into day-to-day operations, allowing teams to respond quickly and consistently across markets.

AI implementation that strengthens, not threatens, compliance

Artificial intelligence (AI) is now part of the regulatory uncertainty landscape. Regulators are closely monitoring its use in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Good Laboratory Practice (GLP), while sponsors seek efficiency without adding risk. The key question is how to deploy AI in ways that enhance quality and speed while maintaining strong human oversight and traceability.

An FSP partner provides a structured approach to managing this uncertainty. Dedicated functional teams bring established governance, regulatory awareness, trained resources, and standardised processes to guide responsible AI use. Using large language models (LLMs), FSP partners summarise complex documents, extract key information, and translate technical content into clearer, patient-friendly language for informed consent forms and lay summaries. This combination of technology and oversight allows sponsors to benefit from efficiency gains while maintaining consistency and quality across deliverables.

Used in this way, AI becomes an enabler, rather than a risk. FSP partners help operationalize its use, freeing senior resource to focus on scientific judgement, regulatory interpretation, and compliance. The result is a more resilient, scalable approach that helps sponsors navigate regulatory uncertainty with greater confidence.

Pharmacovigilance and lifecycle compliance

Beyond regulatory document production, FSP partners support pharmacovigilance (PV) and ongoing lifecycle maintenance, extending oversight well past initial approval. It’s important to note that regulatory uncertainty does not stop at approval. Post-marketing obligations, safety reporting expectations, and lifecycle maintenance requirements continue for years, often across many countries. The workload can be unpredictable and substantial, especially for organisations with broad portfolios.

FSP partners that integrate PV and RA capabilities, supported by embedded regulatory intelligence, help sponsors move beyond viewing marketing authorisation as the endpoint and post-marketing activities as separate. Instead, they enable a continuous product lifecycle approach aligned with evolving regulatory expectations.

By providing structured oversight and proactive management, these teams ensure high-quality dossiers, timely updates, and agile responses to shifting regulatory expectations.

Continuity: Retaining experienced teams through flexible outsourced models

In uncertain conditions, one of the biggest hidden risks is turnover. Every time experienced staff leave a programme, institutional knowledge walks out with them, and the sponsor pays for rework, onboarding time, and preventable errors.

FSP models help protect continuity by keeping dedicated staff aligned to programmes for longer periods, and by offering transition options that retain expertise even during organisational changes. An example of this is “rebadging”, where sponsor staff are transferred and rehired by the FSP partner to maintain the same roles on the same programmes while shifting the employment structure. For sponsors facing restructuring or pipeline reprioritisation, continuity can be as valuable as cost flexibility.

Optimising FSP engagements

To maximise the value of an FSP model, sponsors benefit from treating engagements as structured delivery systems, rather than simply staffing arrangements. Clear governance and escalation paths ensure regulatory changes are triaged and implemented efficiently. Establishing defined quality ownership, including review frameworks for AI-assisted content and audit readiness, safeguards compliance. Embedding regulatory intelligence routines, with documented monitoring and communication practices, supports timely decision-making across geographies. Finally, continuity planning, such as retention strategies and structured transitions for key roles, helps preserve institutional knowledge and maintain operational stability.

Even as regulatory requirements continue to evolve, sponsors that adopt these practices in FSP arrangements are better positioned to keep trials on track, manage timelines effectively, and maintain oversight across global programmes.

References

[1] Tufts CSDD Impact Report Volume 27, Number 6, November/December 2025.

[2] Insights informing strategies for optimizing the collection of clinical trial data. Therapeutic Innovation & Regulatory Science. Springer Nature. 

[3] Deloitte. Measuring the return from pharmaceutical innovation. 15th ed. March 2025. 

About the author

Myriam Antoun is a global business executive with more than 25 years of leadership experience in the pharmaceutical, biotechnology, and clinical research industries. She has built a distinguished career leading global business units, driving organisational transformation, and delivering sustainable growth in highly regulated environments. Her expertise spans strategic planning, business operations, P&L management, regulatory affairs, business development, and global people leadership. As global business unit head for regulatory affairs FSP solutions at Thermo Fisher Scientific, Antoun leads a global organisation focused on delivering innovative regulatory solutions to clients worldwide. Prior to joining Thermo Fisher Scientific, Antoun held executive leadership positions at IQVIA Biotech, PPD, and Pfizer, where she successfully led global organisations through periods of growth, integration, and transformation. Antoun is passionate about developing high-performing teams and building organisations where people and performance thrive together. Fluent in English and French, she is known for leading with integrity, curiosity, and a commitment to excellence.