When it comes to addressing your biometrics challenges, you need flexible services that can be shaped into a tailored clinical trial data management program that meets your precise needs. We offer full biometrics services, including protocol development, (e)CRF design, data management, secure data handling, biostatistics, PK/PD data analysis, clinical study report development, as well as pharmacovigilance and drug safety services. Each service can be provided within full project service outsourcing, a functional service provider (FSP) model or as standalone services.
Our comprehensive services include:
- Electronic solutions: develop, test and release Electronic Data Capture (EDC), electronic Clinical Outcome Assessment (eCOA), Interactive Voice/Web Response System (IVRS/IWRS) and integration of external data loads into the eCRF
- Data management: SDTM compliant, clean clinical database, ready for submission
- Secure data office: handle all data of potentially unblinding nature (PK/PD, lab, randomization)
- PK/PD data analysis: CDISC compliant PK/PD datasets, PK/PD data analysis and reporting
- Biostatistics: advice on protocol design, SAP development and delivery of ADaM compliant datasets and statistical analysis
- Medical writing: a wide range of clear, cohesive and rigorous study documents, fully compliant with ICH-E3, regulatory and your own requirements
- Project Management Biometrics: oversight of all biometrics, drug safety and pharmacovigilance key deadlines and deliverables
- eTMF Services: manage all clinical trial documents easily and securely with the electronic Trial Master File (eTMF) service for Veeva Vault from SGS
To discuss your biometrics requirements, contact us today.