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)

Statistical Programming

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)

Statistical Programming

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.

Anni Gatten, Director of Biometrics at Pharma IT, is pictured smiling.

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, Director of Biometrics at Pharma IT, is pictured smiling.

Anni Gatten Boserup
Director of Biometrics and Principal Pharma Consultant

Do you need assistance with Biometrics?

Reach out to discuss how our team can provide you with
clinical data management or statistical programming support

Do you need assistance with Biometrics?

Reach out to discuss how our team can provide you with
clinical data management or statistical programming support