Beyond the ‘Single Platform’ – A Practical Path to Unified Clinical Trial Execution
Duncan McDonald, eClinical Solutions Advisor | Almac Clinical Technologies
Rethinking the Industry’s Default Position
For over a decade, the clinical trial technology conversation has been anchored around a single idea: The pursuit of a “single platform”.
The premise is understandable, Sponsors are seeking simplicity in an increasingly complex environment; However, in practice, this approach has consistently fallen short.
Not because the ambition is wrong but because the underlying assumption is.
Clinical trials are inherently multi-dimensional. They require specialised capabilities across randomisation, data capture, patient engagement, and operational oversight. There are stakeholders who need access to different combinations of data at different times, in different formats. These functions cannot, and arguably should not, be reduced to a single monolithic system.
The result is a persistent challenge: Fragmentation is not eliminated but redistributed and repackaged.
The Real Problem: Inconsistent Study Logic Across Systems
At the core of this challenge is not the number of systems in use. It is the absence of a consistent, shared representation of the study itself. Today, each system effectively interprets the protocol independently:
- Visit schedules are configured separately
- Data collection rules are duplicated
- Amendments are propagated manually
- Discrepancies are reconciled downstream
This introduces risks with:
- Misalignment across systems
- Increased reconciliation effort
- Reduced traceability
- Greater operational burden at site level
- User Management Issues across systems with names and access
- Challenges with data management and analysis
- Managing multiple integrations and data pools
In short, the study exists in multiple places, in multiple forms, at the same time.
A Structural Shift: Separating Study Logic from System Execution
To address this, the industry is beginning to move towards a more sustainable model: Decoupling study definition from system execution
This is where two emerging concepts become highly relevant:
1. Unified Study Data Model (USDM)
The Unified Study Data Model (USDM) is an emerging industry standard developed to create a consistent, machine-readable representation of a clinical trial protocol.
In practical terms, USDM defines:
- The structure of the study (arms, epochs, visits)
- The schedule of activities (what happens, when, and how often)
- The procedures and data to be collected
- The relationships between all of these components
By translating the protocol into a structured data model, USDM removes ambiguity and attempts to ensure all systems interpret the study in the same way.
Rather than each system configuring its own version of the protocol, USDM provides a single, standardised blueprint that can be reused across the ecosystem.
2. Master Data Repository (MDR)
The Master Data Repository (MDR) is the operational counterpart to USDM.
It is a centralised environment that stores, governs, and distributes the structured study definition.
In this model:
- The study is authored once (aligned to USDM)
- The MDR maintains it as the authoritative source of truth
- Downstream systems (IRT, EDC, eCOA, etc.) consume this definition rather than recreating it
The MDR reenforces the USDM and ensures that:
- All systems are aligned to the same study logic
- Updates and amendments are propagated consistently
- Data definitions remain synchronised across the lifecycle
- Downstream systems impact and risks are reduced
Put simply: USDM defines the study. The MDR ensures it is consistently applied.
Why This Matters Operationally
This shift has direct and measurable implications:
- Consistency Across Systems
- All systems operate from the same underlying study definition
- This reduces configuration variability and downstream reconciliation
Improved Data Integrity
A key regulatory focus has been the integrity of the data. By implementing this methodology, a clinical trial aligns requirements and standards that are indifferent to the providers you are using. This helps to align to a single source of truth for your data. It enhances traceability and alignment with regulatory expectations and principles around data quality, data integrity, system suitability, and computer software assurance.
Reduced Site Burden
When workflows are driven by a consistent model, it reduces the sites overall burden, including:
- Visit alignment across systems
- Tasks follow predictable patterns
- Training becomes reusable
This translates to greater site compliance, fewer data and monitoring issues, and less site time spent entering/working through systems. These are key factors to help speed the onboarding and processing of sites, while reducing the time spent monitoring and addressing preventable data collection issues.
Faster Study Execution
When the eClinical systems are unified, protocol amendments and updates can be propagated more efficiently, reducing cycle times and operational friction. Meetings, UAT, and validation efforts are reduced while providing a smoother implementation. This allows trial sponsors to implement a truly risk based approach, while remaining focused on the overall quality of the trial.
From Concept to Execution: The Role of Orchestration
While USDM and MDR provide the structural foundation, they require an execution layer to translate consistency into operational reality. This is where orchestration becomes critical.
An effective orchestration layer ensures that:
- Systems are coordinated, not just connected
- Workflows are guided, not fragmented
- Users interact through a unified operational experience
You need defined and easily followed workflows, with a unified interface.
What Unification Delivers in Practice
Through ongoing conversations with sponsors and sites, one theme is clear. A single, unified operational environment, supported by one service desk, a streamlined study setup process, and harmonised workflows can materially reduce operational cost and inefficiency.
Importantly, this unification is not achieved by forcing all activity into a single monolithic system, but by orchestrating modular capabilities into one coherent way of working.
For sponsors, these benefits extend across the full clinical trial lifecycle, including study start‑up, execution, and close‑out. This leads to reduced configuration duplication, fewer downstream reconciliation activities, and simpler operational oversight.
For sites, the impact is most pronounced during study execution, where consistent workflows, aligned visit structures, and predictable system behaviour support improved protocol adherence and higher data quality.
These benefits are maximised when unification is intentionally mapped to the services and modules that support execution, rather than treated as a technology consolidation exercise.
Aligning with Almac Trial Coordinator™ (ATC)
The principles outlined above are the basis for the vision behind Almac Trial Coordinator™ (ATC).
ATC is designed to address fragmentation not by replacing systems, but by orchestrating them through a unified operational layer.
Rather than enforcing wholesale platform change, ATC enables sponsors and CROs to extend the value of their current technology landscape, while selectively incorporating Almac Clinical Technologies’ modular solutions where they add the most operational benefit.
Key characteristics include:
- Guided workflows that standardise how tasks are executed across systems
- Single interface interaction for sites and study teams
- Vendor-agnostic integration via open APIs
- Modular architecture that supports best‑of‑breed capabilities, including optional use of Almac’s own modular eClinical solutions (such as IRT, eCOA/ePRO, and eConsent) alongside third‑party technologies
In this model:
- USDM defines the study
- The MDR governs and distributes it
- Almac Trial Coordinator operationalises it
Together, they unify a modern clinical trial by enabling:
- Consistency without constraint
- Integration without complexity
- Flexibility without fragmentation
A More Realistic End State
The future of clinical trial technology is unlikely to be defined by consolidation into a single system. Instead, it will be characterised by:
- Standardised study definitions (USDM)
- Centralised data authority (MDR)
- Orchestrated execution layers (e.g., ATC)
This represents a shift from: “One platform”
To: One model. One source of truth. One way of working.
Conclusion
The industry does not need fewer systems; it needs systems that operate in alignment.
By adopting standardised data models and centralised study definitions and pairing them with effective orchestration sponsors can reduce fragmentation, improve data integrity, and enhance the experience for those delivering trials on the ground.
The “single platform” may remain an appealing concept. However, a coordinated ecosystem, underpinned by shared truth, is a far more practical and achievable solution.
References
- TransCelerate BioPharma Inc. – Unified Study Definitions Model (USDM) https://www.transceleratebiopharmainc.com/initiatives/digital-data-flow/
- CDISC – Clinical Data Standards https://www.cdisc.org/standards
- International Council for Harmonisation (ICH) – ICH E6(R3) Good Clinical Practice https://www.ich.org/page/efficacy-guidelines
- Kush, R. et al. (2020). Electronic Health Data Standards in Clinical Research. npj Digital Medicine https://pmc.ncbi.nlm.nih.gov/articles/PMC4287078/
