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Data Management

Your data are crucial. Data is the language through which sponsors communicate information about investigational drugs to regulatory authorities.

All too often during clinical conduct, the importance of data are minimized and overlooked. Or, the nuances of collection, reporting, and querying of data are not fully appreciated by investigational sites.

Nuventra is unique in that we have implemented and developed a specialized data management and programming team. Many clients approach Nuventra to perform PK/PD analysis on data from a study that has already been completed and the database has been locked. Our services include efforts prior to and following conducting a study.

Our data management team has exceptional experience and expertise when it comes to handling clinical data, specifically in compliance with CDISC standards. We are unique in that we have the capacity to execute full CDISC projects, including generation of both SDTM and ADaM domains. This capability is not often found in the industry. In addition, we do not use automated softwares to generate CDISC domains. Our team generates the domains by hand.

The majority of the time, data are not perfect, which produce oddities when trying to create a standardized final product. Our approach ensures that each dataset, CDISC-compliant or not, is created at the highest quality and accuracy given study specific details and the data collected. Additionally, we can ensure that elements are consistent across datasets and the final deliverable is cohesive.

Dataset generation for modeling projects are also conducted by our programming team. Modeling datasets require very specific, manual formatting. Our team works very closely with the modelers to ensure that decisions being made in data management align with the goals of the project as a whole.

Nuventra’s data management team provides nonclinical support in the form of CDISC SEND dataset generation. Additionally, we have growing capabilities in both GLP and non-GLP projects.

Data Management Services

  • Biostatistics/Bioequivalence/Bioavailability
  • CDISC Dataset Generation
  • Clinical Research Monitor Training for PK/PD Issues
  • CRF and Database Structure Review for PK/PD Data
  • Database Build (Prior to Study)
  • Dataset Generation for Population PK/PD Studies
  • Full CDISC Package Generation
  • Interim PK/PD Data Review
  • Mock Dataset Generation Prior to Database Lock
  • PK Sampling Schedule Review
  • PK/PD Data Management Plan Addendum
  • PK/PD Data Review Tactics
  • Protocol and Study Design Review
  • Review of Electronic Edit-Checks for PK/PD Data

Learn about Drug Development using Real-World Data on our Blog.

Our programming team’s diverse backgrounds and abilities allow us to handle difficult or non-standard studies with ease. Nuventra’s data management services include efforts prior to conducting a study as well as ongoing PK/PD-focused support during study conduct by our team of data managers.

Contact us today to learn more about how our team can help ensure that you get the most out of your data.

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Explore Our Blog

Understanding How PK Data and CDISC Work Together

The “Clinical Data Interchange Standards Consortium” (CDISC) is a not-for-profit organization that develops data standards for drug development. CDISC works…

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Understanding CDISC SEND Data and How to Be Compliant

Nonclinical study data submitted to the FDA must align with the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation…

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What Is CDISC and What Are CDISC Data Standards?

CDISC stands for the “Clinical Data Interchange Standards Consortium,” and is a global not-for-profit organization that actively develops data standards…

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