Biometrics solutions for clinical trials
When protocol design, eCRF set-up, data cleaning, safety review, statistics and reporting operate in silos, small issues don’t stay small. They move downstream, slowing queries, increasing rework and adding unnecessary complexity to submissions.
SGS connects biometrics, medical safety and medical writing expertise under one roof, led by a dedicated project manager biometrics. Choose full outsourcing, targeted staffing, consultancy or a hybrid model without adding unnecessary handovers.
One connected data path
EDC, data management, Biostatistics, PK/PD, medical writing and medical safety work under one roof, with fewer handovers.
One point of contact
CDISC built in early
As a CDISC registered solutions provider, SGS applies CDISC standards across SDTM, ADaM and Define.xml to support efficient reporting and submission.
A dedicated project manager biometrics connects EDC, data management, biostatistics, PK/PD, medical writing and safety teams across the study.
Faster, cleaner data flow
End-to-end semi-automated data flow with validated in-house tools, metadata repositories, eCRF libraries and SAS macros help reduce manual work, increase data quality and shorten timelines.
When you need to be sure
Need a biometrics solution provider for your next study?
Talk to SGS about the right biometrics support model for your trial.
Pharmaceutical company
Client
SGS brings structure to complex biometrics work. The team keeps communication clear, protects study integrity and helps us make decisions with confidence
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How we can support you
EDC set-up and management
Study-specific eCRF design and EDC builds including edit checks, full UAT and integration with IWRS/IVRS, eCOA/ePRO and external data sources.
Data management
SDTM database set-up early after FPI, cleaning, query handling, coding, secure data handling, SAE reconciliation, protocol deviations and external data validation.
Biostatistics and statistical programming
Protocol and eCRF input, sample size calculations, SAPs, interim analyses, ADaM datasets, top line results, TLFs and submission-ready statistical outputs.
Data visualization
Interactive dashboards for study oversight and subject safety monitoring. Choose from our standard library of 40+ dashboards or/and request fully customized dashboards tailored to your study.
PK/PD data analysis
PK/PD analysis including fast preliminary PK outputs for safety meetings, interim analysis, CDISC-compliant datasets, TLFs and reporting.
IDMC solutions
IDMC coordinator and unblinded statistician delivering effective IDMC meeting coordination, unblinded analyses and high-quality reporting to support informed IDMC recommendations.
Make the data flow work before pressure builds
Before your trial even starts, we design how data will flow end-to-end. From data collection and database structure to data review, statistical analysis and reporting, we align all stakeholders from the outset to ensure clarity and consistency. That means early CDISC thinking, eCRF design that serves data management and statistics, dashboards for oversight, secure handling of blinded and unblinded data and short communication lines when things change.
Get the right expertise where the pressure sits: protocol input, EDC design, data management, statistics, PK/PD analysis, IDMC support, reporting or submission-ready outputs.
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About SGS Clinical Research
We're a mid-sized, full-service CRO specialized in early-phase development and biometrics. We offer drug development consultancy, project management, monitoring, data management, statistics, medical writing, safety and regulatory services. We have our own clinical pharmacology unit in Belgium featuring a viral challenge facility and have access to patients through our site network with 400+ sites. Our key therapeutic areas include infectious diseases, vaccines, respiratory, dermatology and oncology.
+350
biometrics specialists co-located in Mechelen, Belgium
+45%
employees with +10 years
SGS seniority
+80%
work done in functional biometrics outsourcing model
+415
studies delivered in
the past 5 years
Request more information
Talk to SGS about the right biometrics support model for your trial.