Full-Service Biometrics Partnership in Clinical Trials

Study strategy and protocol development

Involve experienced statisticians and data specialists before key study decisions are fixed.

Our teams can support:

Protocol statistical input
Endpoint and estimand strategy
Sample-size and power calculations
Randomisation and unblinding planning
Interim-analysis requirements
CRF review
Data and reporting requirements

Early cross-functional input helps ensure that the data being collected is appropriate for the study objectives and planned analyses. Quanticate’s existing biostatistics services include protocol development, sample-size calculations, , randomisation and statistical review of CRFs.

Study set-up and data collection

Build the database, standards and processes required to collect complete, reliable and analysis-ready data.

Clinical data management support can include:

Data management planning
CRF and eCRF design
Database design and build
Edit checks and validation
Data capture and processing
Medical coding
Query and discrepancy management
External-data reconciliation
Database cleaning and lock

Data management works with the statistical and programming teams from study set-up so that collection requirements remain aligned with endpoints, analyses and downstream reporting.

Quanticate’s existing data-management materials describe database design, data capture, validation, discrepancy management, medical coding and database lock, supported by reusable CRF libraries and CDASH-aligned approaches.

Analysis planning

Translate the study objectives into a clear and reviewable statistical approach before final analysis begins.

Support can include:

Statistical Analysis Plans
TFL specifications and shells
Analysis-population definitions
Endpoint derivations
Missing-data and sensitivity approaches
Interim analyses
DMC or DSMB planning
Review of data requirements against the planned analyses

Bringing biostatistics, programming and data management together at this stage reduces the risk of discovering late that required data were not collected or cannot support the planned analysis.

Data standards and statistical programming

Transform raw clinical data into structured datasets and interpretable outputs suitable for analysis and regulatory review.

Our statistical programming teams can support:

CDISC SDTM datasets
ADaM analysis datasets
Dataset specifications
Tables, Listings and Figures
Validation and quality control
Safety outputs
Interim and final analyses
ISS and ISE programming
Submission-ready analysis packages

Quanticate’s programming services include SDTM and ADaM conversion, analysis datasets, TLFs, integrated summaries and safety-data support for DMC and DSMB activities.

Statistical analysis and interpretation

Analyse the study data to assess efficacy, safety and the study hypotheses.

Biostatistical support can include:

Study-level statistical analysis
Review and interpretation of outputs
PK and PD analysis
Meta-analysis
Post-hoc analysis
Sensitivity and supplementary analyses
Statistical reports
Statistical review of clinical study reports

Statisticians remain connected to the protocol decisions, data structure and programming approach established earlier in the study.

Medical writing and study reporting

Bring the study design, conduct, analysis and conclusions together in clear, consistent clinical and regulatory documents.

Medical-writing support can include:

Clinical study protocols
Protocol amendments
Investigator brochures
Clinical study reports
Patient narratives
Submission documents
Publications and scientific communications
Responses requiring coordinated statistical and written content

Integration between statisticians, programmers and medical writers helps maintain consistency between the analysis outputs, interpretation and final documents.

Submission support

Prepare traceable datasets, analyses, outputs and documents that support regulatory review.

Quanticate can support:

CDISC-aligned submission datasets
Analysis datasets and TFLs
Clinical study reports
Integrated summaries of safety and efficacy
Additional and exploratory analyses
Responses to regulatory questions
Updates to datasets, outputs and documents following feedback

The scope can cover an individual study or coordinated support across a wider clinical programme.

Clinical and post-marketing safety

Pharmacovigilance can be added alongside the core biometrics delivery model.

Support can include:

Clinical-trial safety activities
Safety case processing
Safety-database support
Aggregate safety reporting
Reconciliation with clinical data
Safety outputs and analyses
Post-marketing pharmacovigilance

This provides a connected approach to the collection, management, analysis and reporting of safety information throughout development and after approval.

Benefits of a full-service biometrics partnership

One accountable governance structure

A single biometrics partner provides clear ownership across functions, with defined leads and escalation routes. and gives sponsors a clearer view of responsibilities, dependencies and progress across the biometrics journey.

Improved alignment from protocol to reporting

Statistical objectives, data collection, dataset design, analyses and clinical documents are planned as connected activities rather than independent deliverables.

Fewer hand-offs between functions and providers

Reducing the number of separate functional providers can limit duplicated governance, fragmented communication and uncertainty about responsibility at functional boundaries.

Earlier identification of downstream risks

Data managers, programmers, statisticians and writers can identify how decisions made in one function may affect later analyses, reporting or submission requirements.

Consistent standards and working practices

Shared standards, including our Phase I Standardisation, alongside consistent specifications, naming conventions and quality processes support traceability and consistency across the study.

Clearer scope and cost visibility

Connected planning helps define assumptions, responsibilities and dependencies across functions before work begins, reducing the risk of gaps between separately contracted scopes.

Joining an existing programme

A full-service biometrics partnership does not need to begin at protocol development. Quanticate can assume responsibility of your existing biometrics, whether they are currently managed internally or by another provider.

We assess the status of the data, documentation, analyses, outstanding deliverables and key dependencies before agreeing the transition plan. Structured knowledge transfer helps maintain continuity while responsibilities move across to the Quanticate team.

Where a programme is already delayed or underperforming, our rescue-study capabilities can be used to identify priority issues and establish a practical recovery plan.