Clinical Data Management
High-quality data is critical for regulatory success. Our biometrics capabilities clarify your efficacy and safety.
BioFicher can help you by providing sound strategic, scientific and statistical input to clinical research. To improve your study’s functioning (e.g., sample size, design parameters), our experienced professionals conduct simulations in clinical trial settings as part of our biostatistics services to help optimize your trial design and performance. We seek to collaborate with you, proposing advanced statistical approaches, innovative study designs and sophisticated analytical methodologies — and build them into your trial Statistical Analysis Plan.
BioFicher can help you by providing sound strategic, scientific and statistical input to clinical research. To improve your study’s functioning (e.g., sample size, design parameters), our experienced professionals conduct simulations in clinical trial settings as part of our biostatistics services to help optimize your trial design and performance. We seek to collaborate with you, proposing advanced statistical approaches, innovative study designs and sophisticated analytical methodologies — and build them into your trial Statistical Analysis Plan.
When your trials require the analysis of large volumes of genomic, proteomic, transcriptomic, metabolomic and other “omics” data analysis, our biomedical data science & bioinformatics colleagues can deliver a variety of solutions, including machine learning, advanced data visualization, clinical trial data management, pathways analysis, scalable cloud computing and reproducible data analysis methods. Our expertise in this area has helped our clients advance rare disease research and provide better treatment for patients.
BioFicher provides clients the flexibility of working with our Advantage e-Clinical suite of clinical technologies or using other industry systems. For over 7 years BioFicher’ clients have leveraged Advantage eClinical, a 21 CFR Part 11 & Section 508 compliant suite of clinical technologies, to drive efficiencies in their clinical studies. Developed by data management professionals in concert with statisticians, clinicians, medical writers, and others, Advantage e-Clinical offers clients electronic data capture (EDC) for case reporting, IRT for patient enrollment and drug management, ePRO to collect patient insights, safety and pharmacovigilance tracking, MedDRA/WHO drug coding, specimen tracking, and more. To service clients who use other eClinical systems for data collection and management, possesses significant experience across a broad range of leading e-clinical technology platforms and open-source systems.
Data Management Services
BioFicher offers a full suite of clinical data management services to help you generate and analyze data for your clinical studies.
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Protocol development focused on identifying key data points required
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Electronic case report form (eCRF) design
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Development and validation of databases for EDC in clinical trials
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Patient enrollment, registration and site activation
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eConsent development
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Patient safety and pharmacovigilance tracking and reconciliation
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Electronic patient reported outcomes (ePRO) collection and analysis
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Specimen tracking and laboratory management
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Reporting tool configuration
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Development and management of clinical trial websites
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CDISC and statistical programming
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Electronic filing of regulatory submissions following CDISC guidelines
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Medical coding
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Clinical data management training for site personnel
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Data queries, resolution and cleaning
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Data integration services
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Prompt and efficient database lock
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Database maintenance and archiving
To learn more about how BioFicher can help you with data management, please contact us.
Clinica Data Management Leaders
Richarld Dawn
Director, Data Management
Prankle Kashimeh
Associate Director, Data Management