An overview of key procurement trends for clinical development services in 2026
The clinical development ecosystem is undergoing a major transformation. By 2026, clinical development services represent 65-70% of outsourced pharma R&D spending, driven by rising trial complexity, rapid digitalization, and growth in oncology, rare diseases, and advanced modalities like cell/gene therapies and radiopharmaceuticals.
Regulatory systems are also modernizing: the EU’s Clinical Trials Information System (CTIS) is fully live, the UK’s 2025 Amendments take effect in April 2026, China has adopted a 30-day investigational new drug (IND) review, and the WHO’s Global Clinical Trials Forum is pushing global harmonization.
At the same time, pressures from labor inflation to cold-chain volatility are increasing, while sponsors expect faster startups, greater data visibility, and consistent global execution. Digital capabilities, AI-driven feasibility, and integrated clinical-supply solutions have become essential.
For procurement, 2026 is a turning point, marking a shift from transactional sourcing to value-based, ecosystem-led strategies. Organizations that prioritize supplier integration, regulatory readiness, and outcome-focused commercial models will gain advantages in cycle time, cost efficiency, and data quality. [1]
Key Trends in 2026
1. Digitally enabled clinical operations and AI as core differentiators
Clinical development is rapidly shifting toward fully digital-native operations. Instead of relying on separate systems for data capture, patient reporting, consent, remote monitoring, and site communication, leading service providers now offer integrated, end-to-end platforms. These unified environments streamline activities across on-site and remote trial settings, improve data quality, and reduce operational complexity – similar to how integrated supply chain platforms outperform standalone tools.
Data integration and AI have become core differentiators. Sponsors are moving away from fragmented systems (for labs, imaging, patient data, and real-world evidence) and toward clinical data clouds – centralized environments that consolidate, standardize, and manage all trial data in near real time. This creates the foundation for advanced analytics, predictive modelling, and AI-driven insights that improve study speed, quality, and decision-making. [2] [6]
AI is maturing from pilots to production workflows, including [7]:
- AI feasibility (site/patient scoring): Machine learning models optimize country, site, and patient selection, reducing screen failures and protocol amendments while accelerating First Patient In (FPI).
- AI-based Risk-Based Quality Management (RBQM): Models detect data outliers, anomalous site behavior, and endpoint variance, enabling exception-based monitoring rather than full-source data review.
- AI document quality control (QC): Large Language Models (LLMs) check protocol internal consistency, align the Schedule of Activities (SoA) with Case Report Forms (CRFs), reconcile Clinical Study Reports (CSRs) with analysis outputs, and pre-audit Trial Master Files (TMFs), reducing rework.
- Predictive recruitment and trial simulation: Integrated historical and RWE models support better-powered trials with fewer subjects and shorter durations.
Major platform players – e.g., Medidata and CTI – are deepening CRO integrations, while partnerships like eClinical Solutions and ZS are unifying data, analytics, and RBQM, enabling sponsors to manage quality and risk across portfolios rather than trial by trial.
| Key Drivers | Evidence/Examples | Implications |
| Expansion of hybrid and decentralized trial modelsWorkforce shortages in monitoring and data managementRegulatory push for traceability and digital audit trails | Thermo Fisher’s planned $9.4B acquisition of Clario reflects the accelerating convergence of clinical services and digital platformsThe eClinical tech market is expanding at 10–12% YoY, and AI feasibility tools are projected to hit $3.55B by 2029, reflecting widespread investment | Category leaders should pivot from buying isolated tools to building interoperable ecosystemsProcurement will need to assess vendors for API readiness, AI transparency, cybersecurity assurance, and validated integration capability |
2: High-complexity modalities are transforming vendor requirements
Newer treatment modalities, such as cell and gene therapies, rare-disease programs, bispecific antibodies, and radiopharmaceuticals, are becoming pipeline priorities for many biopharma pipelines. Oncology teams are also expanding their antibody-drug conjugate (ADC) portfolios as these therapies show stronger targeting and commercial momentum (e.g., Enhertu, Padcev).
For procurement, this shift significantly changes what is required from external partners. These programs demand specialized CRO capabilities, advanced laboratory infrastructure, high-integrity logistics, and AI-enabled feasibility and site selection tools. [4]
| Key Drivers | Evidence/Examples | Implications |
| Scientific breakthroughs enabling precision medicines Unmet medical needs in severe, rare, or refractory diseases Regulatory incentives & global modernization | More than 250 ADCs in clinical development, with 15 FDA approvals Multiple CRISPR trials entering Phase II for blood disorders and rare genetic conditions.Increasing approvals of AAV gene therapies are creating demand for vector stability and chain-of-identity tracking.Radiopharma startups saw significant Series A and Series B growth in 2024/25. | Specialized CRO capabilities become non-negotiable.Procurement must assess suppliers on:ATMP (Advanced Therapy Medicinal Products) experienceRadiological safety certificationsGene therapy LTFU frameworksGlobal regulatory harmonization capabilities |
3: Regulatory agility accelerates global trial start-up rates
Regulators are modernizing clinical trial oversight frameworks to encourage innovation and improve global consistency. Sponsors with harmonized documentation and RFI-ready filings can activate global trials dramatically faster than before. Suppliers must now demonstrate regulatory readiness, not just operational capability. [4]
- The EU CTR and CTIS now provide a single portal and harmonised assessment process for multi-country EU trials; ACT-EU publishes KPI reports tracking CTIS implementation and volume growth.
- China’s 30-working-day pathway for Class I innovative drugs aims to support earlier global, multi-centre clinical development and serve urgent clinical needs.
- WHO’s Global Clinical Trials Forum (GCTF), launched in October 2025, coordinates global efforts to strengthen trial infrastructure and align best practices.
- UK 2026 reforms: proportionate risk-based review
| Key Drivers | Evidence/Examples | Implications |
| Pressure to reduce start-up timelinesLessons from pandemic-era trial fragmentationGlobal demand for harmonized ethics and regulatory processes | Sponsors prepared with harmonized documentation and RFI-ready submissions are reporting faster approvals than under legacy systems | Prioritize suppliers with CTIS capability, China IND expertise, and UK combined-review readinessConsider regulatory sprint SLAs tied to validation, RFI cycles, and first-country approvals |
4: Supplier consolidation and strategic partnerships redefine the market
Biopharma organizations are increasingly shifting toward fewer, more capable partners that can provide end-to-end visibility across data, operations, and the clinical supply chain. Large CROs are acquiring niche specialists (such as rare-disease CROs, biomarker labs, radiopharma service providers, and advanced analytics firms) to offer broader, integrated capabilities.
Many sponsors are reducing vendor counts by 20-40%, moving from trial-level contracting to enterprise-wide partnerships that streamline oversight and improve consistency. At the same time, CROs, eClinical platforms, logistics providers, and analytics partners are converging into more unified service ecosystems, creating new opportunities for scale efficiencies but requiring more strategic, long-horizon supplier management.
| Key Drivers | Evidence/Examples | Implications |
| Rising trial complexityNeed for unified delivery across data, logistics, and servicesPressure to reduce costs and complexity in fragmented supplier modelsGrowth of preferred-provider and alliance frameworks | Julius Clinical joined forces with Peachtree BioResearch, broadening its U.S. footprint and biostatistics/project management depth for midsize sponsorsLightship, a virtual / decentralized trial specialist, merged with U.S. site network Circuit Clinical to create a combined DCT site platform | Shift from tactical vendor selection to portfolio-level alliances with shared KPIs, joint-business planning, cross-study governance, and multi-year performance modelsValue now comes from shared KPIs (cycle times, recruitment performance, quality/RBQM indices, DCT adoption, diversity metrics) and continuous improvement roadmaps |
5: Rise of performance-based contracting and data-driven procurement
Performance based contracting and ‑data driven procurement are emerging‑ as strategic levers to control cost, derisk vendor spend, and reward measurable outcomes in clinical trials, especially in CRO and technology sourcing.
‑These models link payments and contract extensions to clearly defined KPIs such as recruitment rates, data quality, cycle times, and inspection outcomes, underpinned by much richer operational and financial data than in legacy FFS models. [5]
| Key Drivers | Evidence/Examples | Implications |
| Investment and budget pressuresIncreasing variance in supplier performanceAvailability of digital KPIs across CRO, tech, and logistics categoriesInvestment and margin pressureRegulatory and reputational risk | KPIs now embedded in contracts include: – Enrollment velocity and screen-failure rate – Query-closure time – Site-activation cycle time – Temperature-excursion rates – CTIS RFI turnaround timeAdoption of “risk-based approaches” in clinical data and operations e.g. risk-based monitoring, risk-based study startup, and vendor risk scoring | Negotiate on cycle time, quality and risk (e.g., startup timelines, deviations, data completeness), not just FTE ratesRing-fence metrics that are largely within vendor control (e.g., query closure, RFI turnaround) vs sponsor-driven issues |
6: Labor market tightness drives automation and cost pressure
Labor shortages remain one of the most acute challenges in clinical research. Monitoring, site management, data management, and statistical program programming roles continue to face high turnover and wage pressure, especially in Europe, North America, and developed Asia.
Workforce reports show that global trial volume has grown faster than the research workforce over the last decade, with many sites declining trials or pausing enrollment because they cannot staff them. CROs report ongoing challenges with Clinical Research Associate retention and data-management staffing; many are adopting automation (AI-aided SDV, automated TMF classification, RBQM analytics) to maintain delivery. [8]
| Key Drivers | Evidence/Examples | Implications |
| Experienced CRAs and data managers are leaving due to burnoutIncreased protocol complexity requiring deeper specialist skills5–10% minimum wage increases across Europe (2024–2025) have raised supplier costs, early 2026 signals suggest further but smaller rises about 4% in the UK and 3–5% in several EU markets | CRA turnover rates above 20% in high-cost hubsMonitoring backlog is a top contributor to cycle-time delays and data quality issuesAutomation tools (data QC, eTMF auto-classification, AI-driven SDV prioritization) reduce resource load by 25-40% in some functions | Rate-card inflation is unavoidable, so procurement should prioritize productivity over price cutsContracts should require CROs to provide automation roadmaps, including RBQM, streamlined SDV, and automated coding |
7: Sustainability and ESG pressures shape clinical trials
Pharma companies are under intense pressure to reduce carbon emissions, eliminate waste, and shift to sustainable operations. Current sustainability roadmaps focus on decentralized and hybrid trials (which require less patient travel), optimized logistics, green labs, and digitized records as levers to cut emissions and waste.
| Key Drivers | Evidence/Examples | Implications |
| Increasing corporate ESG commitments (net-zero, Scope 1–3 targets)Energy-intensive cold-chain & cryogenic storageIncreased regulatory encouragement for “green healthcare logistics” | The Sustainable Healthcare Coalition (SHC) and iLCCT consortium (AstraZeneca, Merck, Novartis etc.) released carbon footprint guidance and a clinical trial carbon calculator 2025 to quantify emissions per trial and identify carbon hotspotsCancer Research UK and NIHR funded a method to carbon-footprint publicly funded clinical trials, highlighting major sources such as travel, energy use, and logisticsThermo Fisher / PPD and other large players position decentralized trials and digitalization as part of their Scope 3 reduction strategy, aligned with Paris Agreement goals | Embed carbon accounting requirements into RFPs and MSAsMake sustainability a design constraint alongside recruitment, cost, and data quality |
What this means for procurement
In 2026, procurement must fundamentally reshape how it partners with clinical development. Priority one is designing an integrated supplier ecosystem linking CROs, digital platforms, logistics partners, and regulatory experts into a unified, high-performance network. Traditional sourcing is no longer suited to a world defined by data integration, regulatory alignment, and cold-chain reliability.
Procurement must also drive performance-based contracting, tying commercial terms to clinical outcomes such as faster cycle times, stronger enrollment, fewer deviations, and better data quality. This requires tighter governance, standardized KPIs, and collaboration with clinical operations, data management, and regulatory teams.
Finally, procurement must use digital intelligence – AI forecasting, cost modeling, and performance analytics to shift from reactive buying to proactive value creation. CROs and suppliers with interoperability, regulatory strength, and cold-chain excellence will become long-term strategic partners. [5]
Conclusion
Clinical development in 2026 will be shaped by digital acceleration, regulatory agility, advanced therapies, and a converging supplier ecosystem. By adopting holistic ecosystem strategies, performance-based models, and digital enablement, procurement can shift from a cost function to a driver of trial speed, quality, and innovation.
Leaders who embrace data-driven, performance-focused supplier strategies will achieve major gains in cost efficiency, trial timelines, data quality, and resilience. Ultimately, the winners of 2026 will be those who unify technology, suppliers, logistics, and regulatory readiness into a seamless clinical development engine.
References
[1]”Trends in orphan medicinal products approvals in the European Union between 2010–2022,” 2024. [Online]. Available: https://pmc.ncbi.nlm.nih.gov/articles/PMC10900541/. [Accessed 2025].
[2]”AI-Powered Clinical Trial Feasibility and Forecasting: Four Strategic Applications,” June 2025. [Online]. Available: https://globalforum.diaglobal.org/issue/june-2025/ai-powered-clinical-trial-feasibility-and-forecasting-four-strategic-applications/. [Accessed Nov 2025].
[3]”The 2025 FSP Trends Report,” 2025. [Online]. Available: https://www.ppd.com/resource/2025-fsp-trends-report/. [Accessed 2025].
[4]”Trends in Clinical Trials in 2025: Navigating a Transformative Landscape,” 2025. [Online]. Available: https://www.florencehc.com/blog-post/trends-in-clinical-trials-in-2025-navigating-a-transformative-landscape/.
[5]”Emerging Trends in the Contract Research Organization (CRO) Industry for 2026,” 2025. [Online]. Available: https://www.acldigital.com/blogs/emerging-trends-in-the-contract-research-organization-cro-industry-for-2026.
[6]”Outsourcing clinical trials: the pros and cons in 2026,” 2025. [Online]. Available: https://clinicaltrialrisk.org/clinical-trial-design/outsourcing-clinical-trials-the-pros-and-cons/.
[7]”From Risk to Readiness: Clinical Development Trends Shaping 2026,” Nov 2025. [Online]. Available: https://www.contractpharma.com/exclusives/from-risk-to-readiness-clinical-development-trends-shaping-2026/.
[8]”The 2025 FSP Trends Report,” 2025. [Online]. Available: https://www.ppd.com/resource/2025-fsp-trends-report/. [Accessed Dec 2025].
[9]”NMPA Announcement on Optimizing of the Review and Approval Process for Clinical Trials of Innovative Drugs ([2025] No. 86),” Oct 2025. [Online]. Available: https://english.nmpa.gov.cn/2025-10/14/c_1132769.htm. [Accessed Nov 2025].
[10]”Benefits and Drawbacks of Clinical Development Outsourcing Strategies,” 2025. [Online]. Available: https://isrreports.com/clinical-development-outsourcing-strategies/.
[11]”Top Clinical Trial Trends for 2026: Decentralization, AI Recruitment and RWD,” Nov 2025. [Online]. Available: https://xtalks.com/top-clinical-trial-trends-for-2026-decentralization-ai-recruitment-and-rwd-4502/.
[12]”Breaking down the latest trends in clinical trials,” July 2025. [Online]. Available: https://www.definitivehc.com/blog/latest-trends-clinical-trials.
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