Operational Precision for Modern Trials

Sampling in clinical trials has become significantly more complex — often more quickly than the operational systems that support it. Many studies now involve multiple sample types, evolving biomarker panels, variant collection instructions, and multi-lab routing pathways. Protocol amendments introduce further movement, and sites vary widely in what they can handle.

CROs and sponsors manage these processes effectively when sampling is stable and kit designs remain consistent. But as programmes grow in complexity or begin to diverge from standardised kit formats, the operational load increases disproportionately — and small inconsistencies can have large downstream effects on timelines, sample quality and site experience.

Manage provides a flexible, governed infrastructure for sampling operations, helping CROs and sponsors maintain consistency even as requirements change.

Where Sampling Workflows Typically Struggle

Sampling rarely fails because the science is unclear — it fails when the operational layer beneath it becomes difficult to manage as complexity increases.

For example:

• A protocol amendment updates one tube type or changes a shipping temperature, but existing kit stock still reflects the previous version.
• A liquid biopsy workflow and a tissue workflow need to run in parallel, and small differences in site capability require variations in instructions.
• A lab temporarily changes capacity or a new testing pathway is introduced, but routing must continue without interrupting ongoing kits.
• Sites differ in whether they can centrifuge, store overnight, or maintain cold-chain logistics, making one-size-fits-all kits difficult to deploy consistently.

None of these issues are unusual. They are simply difficult to manage using static kits, manual trackers and partially integrated vendor systems. As sampling requirements diversify, the coordination load grows.

Even well-run CROs may encounter version drift, inventory backlogs or site confusion when the underlying kit and logistics framework is not designed to accommodate variation.

Balancing Flexibility With Control

Traditional pre-built kits work well when trial requirements are stable. They become more challenging when:

• new sample modalities are introduced mid-trial,
• collection instructions must differ across sites or geographies,
• multiple labs require different accessioning pathways, or
• updates need to propagate quickly and consistently.

These situations do not reflect poor CRO practice — they reflect the limits of systems designed for predictability, not variability. Manage is designed to support that variability without sacrificing consistency.

Manage: A Flexible Operating Layer for Sampling

Manage introduces a structured, configurable infrastructure that supports evolving sampling workflows without requiring CROs or sponsors to rebuild their operational model.

Instead of assembling large inventories of fixed kit variants, kits are built dynamically from validated components, with the correct instructions, labels and routing logic applied at the point of order.

This means:

• updated requirements propagate cleanly and predictably,
• multi-modality sampling (e.g., tissue + liquid) does not explode into dozens of kit variants,
• site-specific constraints can be honoured without manual exceptions, and
• kits reflect the latest configuration without rework or relabelling.

The goal is not to replace CRO workflows, but to provide infrastructure capable of supporting the level of variation modern trials increasingly require.

A Technology Layer That Reduces Operational Drift

Manage provides structure where manual processes tend to introduce inconsistency:

• controlled versioning for components, labels and instructions
• transparent tracing of changes across updates
• kit-level barcoding for chain-of-custody and reconciliation
• routing rules that adapt to lab configurations or capacity changes
• automated handling for replacements and reshipments
• visibility into inventory, fulfilment and sample flow

These capabilities reduce the operational drift that can otherwise accumulate in multi-site, multi-workflow studies. The result is a more predictable sampling environment — one in which CROs, labs, sponsors and sites can stay aligned even as requirements evolve.

Supporting Multi-Modality and Multi-Lab Programmes

Studies involving multiple sample types or labs are particularly sensitive to operational variation. Tissue workflows, liquid biopsies, microbiome sampling, or combined modalities often require:

• different packaging standards,
• different instructions or handling steps,
• different accessioning pathways, and
• different return routes.

Manage helps organise these workflows so they can coexist without extensive custom operational builds. Kits can adapt based on modality and site capability, while routing rules ensure samples reach the right destination under the right conditions.

This reduces the need for bespoke coordination and lowers the risk of misalignment between kit, site and lab.

Allowing CROs and Sponsors to Maintain Oversight Without Operational Overload

Sampling logistics and kit management are essential to trial execution — but they are rarely the core area where CROs or sponsors want to invest in specialised infrastructure.

Manage allows teams to maintain:

• control over scientific design,
• consistency in operational execution, and
• visibility into fulfilment and sample flow, while relying on a system built specifically to handle variation, configuration and updates.

This reduces the operational burden without diminishing oversight or quality.

Building Stability Into an Increasingly Complex Process

Sampling workflows are becoming more varied, not less. Panels will continue to expand. Multi-modality sampling will become more common. Site and lab variability will remain a constant operational consideration.

Manage provides the infrastructure designed for this direction of travel — offering the flexibility needed to accommodate change and the structure required to maintain consistency.

Hurdle provides the infrastructure, technology, and expertise to enable the development, validation, and deployment of multi-modal diagnostics at scale.