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.
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.
Following are the Advantages of Biometric Security Systems:-
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