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Data Management Services

ensuring data quality with thoughtful design
ARA Data Management processes and services are designed to provide standards for how work will be completed yet offer the flexibility to customize our support for the needs of your study. With our data management experience in a broad range of therapeutic areas and study designs, we can start work on your study even if protocol development is in progress. Our goal is to ensure your data quality through well-designed data collection, data cleaning, and data management.
flexibility, efficiency, expertise

Database Design, Build, & Test

Database Design, Build, & Test

ARA staff are trained to build and support databases in multiple EDC systems. Understanding the type of data collection necessary may be equal to or more important than the scope or size of the study. Our DM team will collaborate with your study team to ensure screen design, screen behavior, data checks, workflows, reports and integrations (if applicable) maximize your data collection goals.

Our data managers will work with the study team through each step of database development, starting with a review of data entry screens, once drafted. As content and layout is stable, we will proceed through adding the other layers to the database such a field, screen and data check logic.

Once the study team agrees the database build is complete and ready for testing, at least one of our data managers will test the study build to ensure all data is captured as specified in the protocol and related documents. 

All data checks and configured functionality will also be tested. Your study team is expected to perform user acceptance testing (UAT) on the database. The scope of the study team UAT will be defined in the study UAT Plan and related documents. The final database is the culmination of team input, rounds of review and testing.

Mid-study changes are supported with a change process that includes appropriate tracking of changes for the study duration. Before any changes are drafted, the study team will discuss possible risks, if any, associated with desired changes. An abbreviated testing/UAT process is used to ensure any changes to a live database are thoroughly vetted and existing study data is not impacted.

help desk

Database Support & Training

Database Support & Training

ARA provides Help Desk support for all studies built and maintained by ARA. We will work with the study team for support solutions when multiple time zones are involved. ARA suggests that data entry guidelines/user manual documentation is drafted to help site/monitoring staff with questions not specifically answered in CDMS documentation.

We also support the training of all study team members and can customize training needs by role or training format. Investigator meetings, hosted presentations and pre-recorded training videos are some ways training may be supported at your preference.

external integration

Other Data Sources

Other Data Sources

Many studies have data sources external to the CDMS, including corelabs, radiology, safety labs, etc.. Our data management team can support the receipt, reconciliation, and management of these sources. Where integration with CDMS is needed, our team can work with the study team and CDMS vendor to explore possibilities or existing integration opportunities. Data transfer agreements will ensure the consistency and timeliness of data sources being available to our biostatistics and programming team.

support for local

Local Labs

Local Labs
We have extensive experience supporting the use of local labs when central labs are not desirable for your study. Local labs present unique challenges for collection and management, particularly if your study requires SDTM domains programmed. Our team can advise the study team what been helpful or problematic when using local labs.
Creating & generating reports

Data Metrics & Reporting

Data Metrics & Reporting
Reports to support the clinical and study team activities can usually be supported by the CDMS. We can work with the study team to develop reports before or after the database is live depending on team needs. As CDMS reporting capabilities vary, ARA is also able to support creation and generation of reports outside the database, typically using SAS programming.
medical dictonaries

Coding

Coding
Our team supports medical coding using the MedDRA and WHO Drug dictionaries for your coding needs. We recognize that not all device studies are well-suited for dictionary coding and can work with your team for customized coding options supported by the database design.
Supporting systems

ePro / eCOA

ePro / eCOA
The CDMS systems we use do have support for ePRO/eCOA. Some systems support these data more robustly than others and our team can help suggest how your patient-reported data may be best supported.
your living dmp

Data Management Plan

Data Management Plan
The most important document for all things data management is the data management plan (DMP). ARA utilizes in-house developed templates as a starting place to customize and elaborate the details for your study. The DMP is intended to discuss all things data-related, spanning from database development through data lock and study archive. ARA will version-control the document but the DMP is also intended to be a “living” document throughout the duration of the study.
unique for each study

Data Review Plan

Data Review Plan

As every study moves at a different pace and with context unique to the data collected, ARA develops the data review plan specific to the needs of each study. This plan defines data review being conducted beyond the CDMS data checks. Creation of the data review plan and responsibilities for review are jointly developed by ARA and the study team. Review is supported by data extracts, reports, and any other sources helpful for data review.

thoughtful collection & cleaning

Data Quality

Data Quality
ARA processes and tools have been developed with a single goal, data quality. We want to share our expertise and guidance from database development through data review/cleaning to ensure that your data is collected in ways to minimize error and cleaned in layers to produce quality data. Thoughtful data collection and cleaning also ensures downstream activities in statistical programming and reporting result in outputs that demonstrate the goals of the protocol and minimize issues in data standardization (ex. CDISC mapping).
support references

Vendor Collaboration

Vendor Collaboration
As ARA provides a specific set of services in the clinical study spectrum, we commonly work with other individuals and groups who fill out the services required for a clinical study. We may have references for other professionals we have collaborated with or suggestions for how we’ve worked with others to best support your study needs.
ARA | Data Management

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