Biometrics & Clinical Data Management
We offer a wide range of biometrics services for individual clinical studies through to statistical consultancy to integrated databases and regulatory submissions support.
- Database Set-up
- Data Management
- SAS/Statistical Programming
- CDISC Advice, Support & Training
- Statistical Analysis and Reporting
- Regulatory Submission Support
We offer a wide range of services for individual clinical studies through to statistical consultancy to integrated databases and regulatory submissions support.
Our CDISC knowledge is one of the cornerstones of our biometrics capabilities, combined with a strong team of statisticians and SAS programmers.
Many of our consultants work on-site as integrated members of client teams. We also offer full-service integrated biometric services from our UK office (database, data management, and statistical reporting).
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With our many years of knowledge gained working with clinical trial processes, we provide comprehensive and effective programming support to the Pharmaceutical and Healthcare sector.
- Statistical Programming: Derived data creation, generic macro development, statistician support, TFL production, submission preparation
- CDISC Programming: Fully up-to-date on requirements and experienced at producing SDTM and ADaM, annotated CRFs, define.xml, SDRG and ADRG
- CDISC Training: Authorised by CDISC to provide SDTM and ADaM training
- Data Conversion and Integration: Legacy and non-standard data conversion and database intergration
At S-cubed we have a strong focus on accuracy and clarity, whilst still offering a tailored, collaborative service with a quick turnaround, allowing our clients to keep reporting timelines and costs to a minimum. Providing a comprehensive statistical service, we are experienced in attending regulatory agency meetings throughout the world and have experienced many successful client and regulatory audits.
- Study Design – Statistical input for study design and protocols, clinical development plans, sample sizing, randomisation and statistical analysis plans
- Study Reporting – TFL production, interim analysis, pharmacokinetic analysis and statistical report writing
- Analysis – Provision of post-hoc and/or exploratory ad-hoc clinical trial analysis and advice
- Submission Preparation – ISS, ISE and CDISC integrated datasets for electronic submissions (eCTD)
- DSMB – Participation as an independent statistician on DSMBs, including preparation of charters and analyses
- Regulatory Meetings – Preparation and attendance at agency meetings
- Statistical Support – Wide range of additional services, such as Biometrics project management, independent quality control of statistical activities, statistical due diligence (e.g. in-licencing of drugs), journal manuscript input and review, and advice on processes and audit
Clinical Data Management
S-cubed can perform all of these services for a client or act in a consultancy basis on particular aspects.
Our Data Management staff have a vast amount of experience on a variety of database systems and are happy to work on a client’s preferred database solution or provide S-cubed’s solution.
S-cubed’s clinical database solution is OpenClinica. OpenClinica has a large user community (>18,000 people) in over 100 countries, and is used by a wide variety of pharmaceutical, biotech and device companies. It is a user-friendly fully validated 21 CFR Part 11 compliant internet-based system which can be accessed via a range of devices. OpenClinica allows electronic data capture at clinical sites as well as traditional paper entry (or a hybrid approach). OpenClinica also has an ePRO capability with subjects able to enter data (e.g. Questionnaires) directly onto the database via their smart phones or other mobile devices.