Life Sciences Biometrics Services
A comprehensive range of biometrics services from an industry leader with over 35 years’ experience.
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.
Early Phase Clinical Trials Maxims
Discover the early phase clinical trial drug development fundamentals through our Maxims.