Biometrics Consulting
Clinical data management and statistical programming support to ensure consistent and reliable data for submission
Biometrics
Clinical data management and statistical programming support to ensure consistent and reliable data for submission
Our Biometrics experts can support you from Phase I to IV
At Pharma IT, we focus on providing experienced consultants that provide extraordinary service quality based in extensive industry expertise. Our consultants can assist you with both clinical data management and statistical programming support.
Our Biometrics experts can support you from Phase I to IV
At Pharma IT, we focus on providing experienced consultants that provide extraordinary service quality based in extensive industry expertise. Our consultants can assist you with both clinical data management and statistical programming support.
Our solutions are tailored specifically to the needs of every client.
Pharma IT's Biometrics Team can assist you with:
Data Management (DM)
• Sponsor oversight covering DM activities from set up to trial closure
• Protocol review & input
• eCRF Design
• Data standardization, data review, data validation, and data reconciliation
• External vendor collaboration
• Database Lock activities and DM documentation
• External data transfer and data flow documentation
• Quality Control
• Data analysis and customer compliants on drugs & medical devices
• ePROs
• eSAE Set Up
• Business projects (e.g. Medidata RAVE URL and Ryze MDR implementations)
• Sponsor oversight of CRO programming activities, including contract negotiations
• Development, validation, and documentation of SAS programs
• CDISC/SDTM/ADAM data standards and TFL’s validation
• Development and validation for submission packages
• Documentation of Annotated Case Report Form (ACRF)
• Define.xml’s and Reviewers guide (SDRG/ADRG)
• Data anonymization, de-identification, and Data Sharing procedures
We also offer Functional Support, including cross functional work with other Pharma IT consultants in the following areas:
• URL Implementation and system validation support
• Clinical Operations & Medical Writing
• Trial Master File set-up and maintenance
• Drug Safety
• Audit/Inspection Preperation
Our solutions are tailored to the needs of every client.
Pharma IT's Biometrics Team can assist you with:
Data Management (DM)
• Sponsor oversight covering DM activities from set up to trial closure
• Protocol review & input
• eCRF Design
• Data standardization, data review, data validation, and data reconciliation
• External vendor collaboration
• Database Lock activities and DM documentation
• External data transfer and data flow documentation
• Quality Control
• Data analysis and customer compliants on drugs & medical devices
• ePROs
• eSAE Set Up
• Business projects (e.g. Medidata RAVE URL and Ryze MDR implementations)
• Sponsor oversight of CRO programming activities, including contract negotiations
• Development, validation, and documentation of SAS programs
• CDISC/SDTM/ADAM data standards and TFL’s validation
• Development and validation for submission packages
• Documentation of Annotated Case Report Form (ACRF)
• Define.xml’s and Reviewers guide (SDRG/ADRG)
• Data anonymization, de-identification, and Data Sharing procedures
We also offer Functional Support, including cross functional work with other Pharma IT consultants in the following areas:
• URL Implementation and system validation support
• Clinical Operations & Medical Writing
• Trial Master File set-up and maintenance
• Drug Safety
• Audit/Inspection Preperation
Pharma IT's Biometrics team consists of highly qualified professionals
Our extensive experience uniquely positions us to contribute with specialist perspectives, experience, and advice on your project while ensuring that the tasks at hand get solved and milestones are met. Whether your project is performed in house or is partly or fully outsourced, Pharma IT’s consultants offer flexible support while ensuring consistent and reliable data for submission.
Pharma IT's Biometrics team consists of highly qualified professionals
Our extensive experience uniquely positions us to contribute with specialist perspectives, experience, and advice on your project while ensuring that the tasks at hand get solved and milestones are met. Whether your project is performed in house or is partly or fully outsourced, Pharma IT’s consultants offer flexible support while ensuring consistent and reliable data for submission.
We help you ensure consistent and
reliable data for submission
Pharma IT’s senior consultants hold vast experience from previous pharma and biotech roles – supporting all phases of clinical trials. We take ownership of our work, with a focus on accuracy and reliability. When you work with Pharma IT you can rest assured knowing our qualified experts can support your organization and ensure consistent and reliable data for submission fully compliant with applicable laws, regulations, and guidelines. Whether your project is performed in house or is partly or fully outsourced, Pharma IT’s consultants offer flexible support while ensuring consistent and reliable data for submission.
Anni Gatten Boserup, Director of Biometrics and Principal Pharma Consultant
We help you ensure consistent and
reliable data for submission
Pharma IT’s senior consultants hold vast experience from previous pharma and biotech roles – supporting all phases of clinical trials. We take ownership of our work, with a focus on accuracy and reliability. When you work with Pharma IT you can rest assured knowing our qualified experts can support your organization and ensure consistent and reliable data for submission fully compliant with applicable laws, regulations, and guidelines.
Anni Gatten Boserup
Director of Biometrics and Principal Pharma Consultant
