Data Management
Your database, built right from the start.
Most biometrics problems originate at the database design stage, not the database lock stage. A protocol with endpoint ambiguity, a database with poorly designed CRFs, incorrect visits configuration, and incomplete edit checks - these decisions made early determine the quality of data you end up with later.
We engage before the database is built. We review your protocol, raise design questions, and flag issues before they become protocol amendments, database unlocks, and/or submission delays. It is not an additional service. It is how we work on every study.
We build databases in 6 to 8 weeks. The industry standard is 12 weeks. That difference comes from experienced people, well-defined processes, and a team that has built databases across a wide range of therapeutic areas and study types.
Services include
EDC database design and build
Medical coding
Data cleaning
Query management
Database lock
Biostatistics
Analysis you can submit with confidence.
A statistical analysis plan that is unclear, incomplete, or misaligned with the regulatory environment your study is targeting creates problems at submission. Regulators query. Timelines slip.
Credibility suffers.
Our biostatistics team works across all phases of clinical development, from early-phase study design through to regulatory submission. We write statistical analysis plans that are clear, defensible, and written for the regulatory reader from the outset. We engage at the protocol stage where possible, because the decisions made before a study starts directly affect the quality of the analysis at the end.
We are one of a small number of Australian CROs with direct FDA/EMA submission support capability. For sponsors pursuing a US or EU regulatory pathway, that removes a layer of risk and a layer of cost.
Services include
Trial design
Statistical modelling
Sample size estimation
Statistical analysis plans
Programming and analysis
Regulatory submission support
Integrated summaries of safety and efficacy
Statistical Programming
Clean outputs. Validated datasets. On time.
Tables, listings, and figures need to be accurate, complete, and formatted to the standard required for regulatory submission. CDISC-compliant SDTM and ADaM datasets need to be developed, validated, and quality controlled by people who understand the submission environment they are going into.
Our statistical programmers work in-house, alongside the same team that built your database and wrote your statistical analysis plan. There is no translation layer between disciplines. From database lock, we deliver draft TLFs within two weeks.
Services include
SDTM and ADaM dataset programming
TLF production
Validation
Medical Writing
Documents that are clear, correct, and clinically compelling.
A clinical study report is not just a summary of what happened.
It is a regulatory document that needs to present your data accurately, completely, and in a format that meets the expectations of the authority reviewing it. Poorly written clinical documentation invites queries. It creates delays at the point in a program where delays cost the most.
Our medical writers work closely with the biostatistics and data management teams throughout the study, not just at the end. That means documents that reflect the data without ambiguity, written and reviewed by people who were involved in producing it.
Services include
Protocols
Clinical study reports
Regulatory documents
Patient-facing materials
Integrated summaries of safety and efficacy
