ESG as a Quality System: Practical Steps to Embed Sustainability Into Vendor Oversight

Clinical development organizations are under growing pressure to demonstrate credible environmental, social, and governance (ESG) performance, particularly across value chain (Scope 3) emissions and supplier practices. Simultaneously, trial teams are managing increasing protocol complexity and relying on a larger network of specialized vendors. Recent industry discussion has highlighted these dynamics across digital trial technology, patient travel burden, and clinical trial supply chain sustainability.^1,2

In this article, I explain why ESG efforts often fail to stick when they are managed as a parallel reporting exercise and provide a practical approach for sponsors to embed ESG into existing vendor oversight mechanisms without creating a new bureaucracy. The intent is not to expand Good Clinical Practice (GCP) requirements. The intent is to integrate ESG signals into the same operating discipline clinical teams already use to manage risk, performance, and continuous improvement.

Why ESG is moving into the clinical operations lane

Most sponsors’ clinical development footprints are shaped by outsourced work. Technology platforms, central laboratories, specialty logistics, depots, imaging providers, home nursing networks, packaging, and site support services all influence emissions, waste, and patient experience. Those impact drivers are rarely visible through corporate policies alone. They are visible through trial design choices and supplier delivery models. The discussion of emissions drivers, including travel, logistics, and trial operations, reflects this reality.²

A second reality is that the operational data needed to quantify and manage footprint is often held by vendors and their subcontractors. Studna has described the industry’s efforts to build practical tools and frameworks to assess clinical trial carbon footprint, in part because data collection has historically been inconsistent across stakeholders.³ The implication for clinical operations leaders is practical: if ESG performance is expected, it must be built into the way vendors are selected, governed, and improved.

The most common failure mode: ESG as a reporting system

In practice, many ESG programs in clinical development are designed primarily to collect documentation, score suppliers, and support corporate reporting timelines. Vendor oversight is designed to manage operational risk and delivery performance.

When ESG remains a reporting system, organizations frequently see:

• Questionnaires that generate non-comparable data across suppliers
• Metrics without clear boundaries, methods, or auditability
• Improvement actions that are not connected to ongoing vendor governance routines

This mismatch creates friction. Sponsors feel they are making progress because they have completed surveys. Suppliers experience repeated information requests that do not translate into clear operational priorities. Under delivery pressure, teams revert to what is governed and measured. If ESG is outside those routines, it is vulnerable to being deprioritized.

Why ESG is increasingly part of the quality equation

Treating ESG as part of vendor oversight does not require claiming that ESG and GxP are the same. The more grounded point is that ESG readiness often correlates with operational maturity. Suppliers that can produce consistent, decision-grade ESG data typically have defined process ownership, stronger data governance, clearer documentation discipline, and established escalation paths. Those same characteristics reduce surprises in delivery and improve readiness for audits beyond ESG.

In my experience across sponsor and vendor environments, the strongest oversight programs share a simple feature: they translate expectations into measurable performance, reviewed on a cadence, with clear ownership for corrective actions. ESG data that cannot meet those standards rarely changes behavior. ESG data that is decision-grade can become a useful risk and performance signal in the same way that quality and delivery metrics are used today.

Shift the target from “perfect ESG data” to decision-grade ESG

Most trial organizations do not need perfect ESG data across every vendor. They need decision-grade data that is fit for vendor selection, oversight, and improvement. The Greenhouse Gas Protocol’s Scope 3 Standard emphasizes understanding value chain emissions to focus efforts on the most significant reduction opportunities, using standardized approaches.⁴

Decision-grade ESG has three characteristics:

1. It is material to the service being delivered. Focus on footprint and social risk drivers that actually move with the vendor’s work.
2. It is comparable across suppliers. Use standardized definitions, boundaries, and assumptions so the data is interpretable.
3. It is actionable within governance. Data should feed decisions: supplier selection, network design, shipment strategy, packaging choices, monitoring models, and corrective actions.

A practical way to implement this is a tiered maturity model. Tier 1 metrics are baseline and self-reported, useful for direction-setting. Tier 2 metrics use standardized boundaries and definitions, enabling comparisons and trend management. Tier 3 applies selective verification for the most material categories, supporting stronger assurance. This tiering approach can reduce burden while improving credibility over time.

Where to embed ESG in the vendor oversight lifecycle

The most efficient way to operationalize ESG is to insert it into oversight moments that already exist. Four points in the vendor lifecycle typically provide the highest leverage.

1. Supplier qualification and selection

Add ESG criteria in a way that reflects materiality and maturity rather than applying uniform requirements. As Henderson noted, the lack of a single standard reference for calculating trial emissions and the need to use evolving tools and consistent methods.² In practical terms, sponsors can segment suppliers by ESG influence and operational criticality, then tailor the ESG ask by category.

Practical steps:

• Segment suppliers by ESG influence and operational criticality, not spend alone.
• Use a small, standardized set of questions mapped to the service category.
• Evaluate the supplier’s improvement pathway, not only current-state performance.

Avoid:

• Applying identical ESG requirements to all suppliers regardless of footprint or role.
• Penalizing incomplete data without allowing an improvement plan and timeline.
• Selecting vendors based on broad claims that are not supported by traceable methods.

2. Risk assessment and oversight planning

Use ESG signals to inform the overall risk posture of a supplier and the intensity of oversight. This does not require turning GCP audits into ESG audits. It means including ESG in risk-based thinking, especially where it intersects with business continuity, logistics resilience, and workforce stability.

Examples of ESG-linked operational risks that can matter to trial delivery:

• Cold chain lanes with limited alternatives and weak continuity planning
• High dependence on energy- or water-intensive processes without resilience measures
• Limited sub-tier transparency in logistics, home health, or sample handling networks
• Workforce practices that increase attrition in critical delivery roles

3. Governance rhythms: QBRs, scorecards, escalation

Most sponsors already conduct quarterly business reviews (QBRs) and track vendor performance via scorecards. ESG should be folded into those structures with the same discipline applied to other performance indicators.

Practical approach:

• Add two to four ESG metrics that are material to the service category.
• Review trend lines and drivers, not only point-in-time values.
• Tie ESG actions to accountable owners and timelines.
• Escalate when ESG issues create delivery, safety, or reputational risk.

The goal is operational tracking, not presentations. If ESG is reviewed as part of the same scorecard that includes delivery and quality, it is more likely to survive timeline pressure.

4. Corrective and preventive action and continuous improvement

When ESG gaps are identified, manage them like other performance gaps. Define the gap precisely, identify root causes, implement corrective actions with measurable outcomes, and confirm effectiveness on a set cadence. This approach turns ESG from a campaign into managed work.

Practical metrics by vendor category

To keep ESG embedded and lightweight, align metrics to categories that frequently drive footprint and operational risk in trials. Here are some examples of decision-grade metrics (illustrative, not exhaustive):

Specialty logistics and depots

• Emissions per shipment lane, with defined boundary and allocation method
• Temperature excursion rate and wastage tied to excursions
• Packaging utilization and reuse rate, where applicable

Central labs and sample management

• Sample shipment frequency and mode (air, ground, courier)
• Dry ice usage per shipment, where measurable
• Sample retention practices and waste reduction initiatives

Technology vendors (eCOA, eConsent, digital health technology)

• Cloud usage allocation method and emissions factor approach
• Device lifecycle practices (refurbishment, reuse, return rates, e-waste handling)
• Reduction initiatives linked to shipment consolidation and paper minimization

Others have noted that digital health technology providers can influence footprint through device reuse, refurbishment, and logistics optimization, while noting the challenge of comparable emissions baselines due to evolving tools.¹ The key is to choose metrics that can be made comparable and tracked over time, then expand as maturity improves.

Common pitfalls and how to avoid them

1. Confusing volume of data with credibility. More metrics can increase noise. Start with material drivers and consistent boundaries.
2. Creating a parallel ESG bureaucracy. If ESG introduces new meetings and templates outside vendor oversight, it is likely to be deprioritized when timelines compress.
3. Treating suppliers as the problem to solve. Suppliers vary widely in maturity and resources. Sponsors can raise standards without destabilizing the ecosystem by standardizing requests, segmenting expectations, and supporting improvement pathways.
4. Assuming sustainability always adds cost or time. Some changes do add cost. Others can reduce waste, optimize shipments, and improve planning discipline. Test and quantify rather than assume.

Four moves sponsors can implement in 60 days

Organizations do not need to wait for an enterprise ESG transformation to begin. A focused pilot can move ESG from reporting to oversight quickly.

1. Identify the suppliers that drive the greatest footprint or social risk based on service category and operational dependency.
2. Define two to four standardized metrics per category with clear boundaries and assumptions.
3. Add those metrics to existing QBR scorecards and governance agendas.
4. Require improvement plans for gaps, with owners and timelines, and track them like other performance commitments.

This approach aligns with industry efforts to build tools and frameworks for consistent carbon footprint assessment across trial activities and stakeholders.²

A closing test: three questions for supplier governance meetings

If you want to assess whether ESG is embedded in trial execution or still bolted on, ask these questions in your next supplier governance meeting:

• Where does our work with you drive the trial footprint (logistics, energy, travel, materials, waste), and which one lever matters most to change it?
• What ESG metric are you confident enough to stand behind in an audit today, and what would it take to make the next metric equally credible within 12 months?
• In a delivery crisis, what sustainability practices will we protect because they reduce operational risk, and what practices would we likely abandon because they were bolted on?

When these questions produce specific metrics, methods, owners, and decisions, ESG has moved into the operating system. When they produce general statements, ESG is still operating primarily as a reporting exercise.

Otis Johnson, PhD, MPA, Founder & Principal Consultant, Vantix Operations

References

1. Haenel, Estelle, Farrell Healion, and Scottie Kern. "Answering the Sustainability Call: Digital Health Technologies and eCOA." Applied Clinical Trials, October 14, 2025. Accessed January 22, 2026. https://www.appliedclinicaltrialsonline.com/view/answering-the-sustainability-call-digital-health-technologies-and-ecoa
2. Henderson, Lisa. "DIA Europe 2023: De-Carbonizing Your Clinical Trials." Applied Clinical Trials, March 24, 2023. Accessed January 22, 2026. https://www.appliedclinicaltrialsonline.com/view/dia-europe-2023-de-carbonizing-your-clinical-trials
3. Studna, Andy. "Sustainability in Clinical Trials: The Pistoia Alliance’s Initiative to Assess Carbon Footprint." Applied Clinical Trials, April 7, 2025. Accessed January 22, 2026. https://www.appliedclinicaltrialsonline.com/view/sustainability-clinical-trials-pistoia-alliance-initiative-carbon-footprint
4. Greenhouse Gas Protocol. "Corporate Value Chain (Scope 3) Standard." Accessed January 22, 2026. https://ghgprotocol.org/corporate-value-chain-scope-3-standard