Phase I Standardisations

What are Phase I Standardisations?

Phase I Standardisations are Quanticate’s innovative framework for standardising how studies are processed: from raw data through to analysis-ready structures. They provides a consistent backbone for clinical programmes by aligning datasets, workflows, and implementation approaches to CDISC standards, or to agreed sponsor-specific standards where appropriate.

When to Use Phase I Standardisation

Aimed at emerging biotechnology companies and Phase I units, Phase I Standardisations are best suited to Phase I or other early-phase programmes with studies that are similar in design and benefit from repeatable setup. Once standards are established in an initial study, they can be applied efficiently across subsequent studies. We recommend using our standardisation when you need:

Large volumes of similar or related studies
Strong adherence to CDISC or defined sponsor standards
Predictable timelines and reproducible results
Faster iteration in early-phase safety programmes

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Why Standardisation Matters

Standardisation creates one clear, compliant way of running studies. When inputs vary widely, whether due to protocol design, endpoints, source data, or study-specific instructions, delivery becomes slower and the risk of errors grows.

Our Phase I Standardisations reduce avoidable variability, so each step can run in a more consistent and controlled way, so teams can move faster, work more predictably, and maintain quality across studies. If your study is more complex, then advanced statistical methods will be more appropriate for you.

Key Benefits of Benefits of Phase I Standardisation

Speed and Predictability

Faster setup and execution for repeatable, structured studies, with a clearer, more predictable path to submission

Quality and Compliance

Greater confidence in standards alignment, traceability, and regulatory readiness

Lower Operational Risk

Fewer hand-offs, fewer cosmetic fixes, and reduced delivery risk

Reusability and Reproducibility

Reliable, repeatable processes that scale across studies, programmes, and Phase II–III, increasing efficiency as standards are reused

Scalable Governance:

Central updates reduce rework and keep studies aligned as standards evolve

Controlled Flexibility

Adapt to study-specific requirements without rebuilding the core process or losing control

How our Standardisations Work

Phase I Standardisations create efficiency by combining predefined standards, mapped workflows, and repeatable outputs. When sponsors align to Quanticate’s standards and output suite, studies can move more quickly through a consistent, controlled delivery model.

Standards Alignment is Defined

Quanticate has established mappings from a core set of Case Report Forms (CRFs) through SDTM to ADaM standards. By adopting these standards, sponsors can benefit from a more efficient, lower-cost delivery model built on predefined, validated mappings.

Ready-to-run Output Formats

By going through this standard flow to ADaM standards, associated outputs can also be prepared in line with the ADaM structure, enabling faster and more consistent downstream delivery.

Configurable Repeat-Study Model

If you are running multiple studies, sponsors can deviate from the standard approach at a small cost to the first study. Once established, that updated library can be reused to support the rapid delivery of subsequent studies with the same structure.