Specialist Expertise. Regulatory Focus. Practical Delivery.
Novastatix Ltd. is a Canadian specialist biometrics and life-sciences technology company supporting pharmaceutical, biotechnology, generic-drug, biosimilar, natural health product, medical-device, healthcare and clinical research organizations.
We provide focused technical support across clinical development, pharmaceutical product development, regulatory submissions and healthcare technology through a flexible and quality-focused delivery model.
Specialist by design.
Novastatix was established in Canada to provide focused biometrics, clinical data, regulatory and life-sciences technology support through a practical and flexible engagement model.
We support defined work packages, study-level assignments and broader program requirements across clinical development, pharmaceutical product development, regulatory submissions, medical devices and healthcare technology.
Our focus is on technically demanding assignments where statistical rigor, data traceability, regulatory awareness, quality and dependable execution are essential.
Unlike a broad-based outsourcing organization, Novastatix is structured to provide focused expertise, responsive communication and delivery arrangements aligned with each client’s specific requirements.
Explore Our ServicesOur Delivery Model
Canadian client engagement. Specialist delivery.
Client engagement, contracting and project oversight are managed through Novastatix in Canada.
Delivery resources are aligned with the technical, operational and regulatory requirements of each assignment. Depending on the agreed scope, work may be performed through Novastatix personnel, experienced delivery professionals and approved specialist collaborators.
Our model is designed to support individual deliverables, defined work packages, complete study assignments and ongoing program requirements while maintaining appropriate technical oversight, quality control and accountability. Delivery can be structured to work alongside sponsor teams, existing CRO arrangements and incumbent vendors where a program already has them in place.
Specialist-Led Engagement
Experienced specialists remain involved in scope definition, technical decisions, review, issue resolution and delivery oversight.
Flexible Resourcing
Resources are aligned with the complexity, timelines, systems and technical requirements of each assignment.
Defined Engagement Models
Support can be structured as a fixed-scope project, study-level assignment, dedicated-resource arrangement or longer-term program engagement.
How We Work
Quality, confidentiality and controlled delivery, built into every stage.
Quality is incorporated into the way every assignment is planned, developed, reviewed, documented and delivered.
The specific controls applied are determined by the project scope, associated risks, applicable standards, sponsor procedures and contractual requirements.
Clear Scope and Responsibilities
Deliverables, assumptions, dependencies, responsibilities, timelines, input requirements and review expectations are documented before work begins.
Independent Quality Control
Critical datasets, programs, analyses, tables, figures, listings and submission deliverables are independently reviewed or validated according to the agreed project plan.
Traceability and Reproducibility
Specifications, source data, transformations, analysis datasets, programs, outputs and supporting documentation are managed using appropriate version-control practices and documented change history to preserve traceability and reproducibility, with backup and retention controls applied according to the engagement.
Confidential Project Handling
Confidential study and product information is handled through appropriate confidentiality arrangements, including mutual non-disclosure agreements where appropriate, controlled project access and agreed information-handling procedures throughout the engagement.
Controlled Environments and Delivery Locations
Work can be performed within sponsor-provided validated systems and client-controlled environments. Project access, data residency and delivery locations are governed by sponsor requirements and contractual approval, including Canadian data-residency and Canada-only arrangements where required.
Standards and Regulatory Alignment
Work is aligned with applicable sponsor procedures, regulatory guidance, industry standards, statistical methodology and project-specific requirements.
Reliable support. Clear accountability.
We are committed to delivering technically sound, traceable and review-ready work through documented processes and accountable project management. Project status, dependencies, technical questions, risks, assumptions and scope changes are communicated clearly throughout the assignment.
We aim to build long-term client relationships based on delivery quality, responsiveness, transparency and practical collaboration, not simply the completion of individual assignments.
Support structured around your requirements.
Whether you require a defined technical deliverable, a complete study assignment, regulatory submission support or an ongoing delivery arrangement, Novastatix can structure the engagement around your scope, systems, timelines and quality requirements.
Share your project requirements, available inputs, expected deliverables and target timelines. We aim to provide an initial scope and timeline within one business day, Eastern Time.
Discuss Your Requirements