CONFIDENTIALITY
Protected project information
Mutual NDAs can be executed before confidential protocols, datasets or product information are shared. Access is limited according to the agreed project model.
Clinical & pharmaceutical statistical consulting for regulatory development
Clinical & pharmaceutical statistics built for regulatory submission.
Biostatistical services, pharmaceutical statistics, CDISC migration, statistical programming, custom software and digital solutions, and regulatory submission support for Phase I–IV clinical trials across pharmaceutical, biotechnology, generic drug, biosimilar, and natural health product programs.
Discuss Your Project- Biostatistics
- Pharmaceutical Statistics
- Clinical Data Management
- CDISC & Data Standards
- Software & Digital Solutions
350+studies represented in our team’s FDA submission experience
30+years of combined domain and delivery experience
16therapeutic and product areas
Every number we deliver is traceable to its source and reproducible on demand.
We build submission deliverables as version-controlled, metadata-driven pipelines rather than one-off programs. Conformance checks are integrated throughout development, and submission metadata is maintained alongside the datasets it describes.
That approach makes interim analyses, committee outputs, agency questions and subsequent studies easier to reproduce, review and extend without rebuilding the delivery process from scratch.
What we do
Five core practices, engaged individually or across the lifecycle of a development program.
01
Biostatistics
Study design, sample size, SAPs, randomization, efficacy and safety analyses, interim support, DMC/DSMB deliverables and integrated summaries.
Study design / SAP / DMC & DSMB / Integrated analysesExplore Biostatistics →02Pharmaceutical Statistics
Bioequivalence and PK statistics, dissolution and f2, particle-size PBE, stability and shelf-life, formulation and product-development statistics.
ABE & RSABE / PBE / Dissolution & f2 / StabilityExplore Pharmaceutical Statistics →03Clinical Data Management
Structured data-management support across study setup, CRF/eCRF design, query management, external and safety reconciliation, database-lock readiness and final data delivery.
Study setup / CRF & eCRF / Queries / Reconciliation / Database lockExplore Clinical Data Management →04CDISC & Data Standards
CDISC migration, SDTM and ADaM implementation, submission metadata, reviewer guides, standards remediation and conformance support.
Migration / SDTM / ADaM / Define-XML / SDRG & ADRGExplore CDISC & Data Standards →05Healthcare, Medical Device & Life Sciences Software Solutions
Custom software, digital solutions, 3D visualization, BI/KPI dashboards, quality and compliance applications, and workflow automation for healthcare and life sciences organizations.
Custom software / Medical device / 3D / BI & KPI / Workflow automationExplore Software Solutions →Confidentiality, Quality & Controlled Delivery
Practical controls for regulated and confidential work—defined according to project scope, sponsor procedures, system requirements and contractual obligations.
ENVIRONMENTS
Sponsor-controlled systems
Where required, work can be performed entirely within sponsor-provided validated environments and client-controlled systems, following applicable sponsor procedures and access controls.
TRACEABILITY
Reviewable, reproducible delivery
Specifications, programs, datasets, outputs and supporting documentation are managed to preserve traceability, version history and reproducibility appropriate to the engagement.
REGULATED WORK
Project-specific requirements
Applicable GxP, electronic-record and 21 CFR Part 11 considerations can be addressed during scoping where they form part of the sponsor's systems, procedures or contractual requirements.
Why sponsors choose Novastatix
- Specialist depth across biostatistics, pharmaceutical statistics, CDISC & data standards, software development and statistical programming, with senior oversight throughout each engagement.
- Our own licensed SAS environment is available, and we can also work entirely inside sponsor-provided validated environments where required.
- FDA and Health Canada deliverables can be supported by one team using a consistent statistical and data foundation across both submissions.
- Canadian data residency is available. Project access and delivery locations are governed by sponsor requirements and contractual approval, including projects that require Canada-only or sponsor-hosted access.
Send us the project brief.
For clinical, statistical or data-management work, send the phase, indication, approximate subject count and required deliverables. For software projects, send the workflow, users, systems and desired outcome. We aim to return an initial scope and timeline within one business day, Eastern Time.
info@novastatix.ca