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Data Management

Are You Looking for Data Management from a CRO that Will...

Lead the study team to drive, build, and lock timelines?
Support remote SDV and virtual clinical trials?
Prioritize CRA and DM collaboration and communication?

ARG’s database builds and locks are a partnership of transparency.

Tell Us About Your Study

What do ARG’s Data Management Services Include?

Cross Functional SPM’s

Project dashboards that provide real-time metrics that inform dependable insights.

Custom Listings In-House

Programmers adept in Python, R, and SAS to support custom study requests.

Dedicated DM Leads and Programmers

Collaboration to reflect protocols in user-friendly formats for efficient database entry.

Database Build and Lock

Cross-functional efforts led by DMs who have the experience to keep every detail on track.

Data Management Plan

Regularly updated documentation of requirements to ensure teams have a useful tool.

Access to Schedules

Accessible monitoring schedules to help teams code data and resolve queries before next visit.

Ongoing Query Quality Review

Cross-functional QQR process that proactively prevent issues and mitigate risk.

Clinical Data Coding

Collaboration between coding team and Medical Monitors to ensure correct coding of terms.

External Labs, SAE, Image Reconciliation

Reconciliation and data availability through strong vendor relationships and documentation.

Meet an ARG Data Manager

Alychia Deming - Data Management for clinical trials

Alychia Deming

Associate Director, Data Management

ARG DM provides a genuine partnership with sponsors, allowing feedback and changes in real time. Working so closely with the sponsor really helps us fight for the client’s vision.

Why Choose ARG for Your Data Management Needs?

CDASH Libraries Ready to Go Performed annually for employees with random sampling to update training documentation.
Monitoring Options Track record of remote monitoring to support the technology and options for any trial.
DM Access to CRA Calendars Cross-functional work with Biostatistics to develop compliant, SDTM-ready core forms.
Transparent Timelines Project Manager, Clinical Team Build and Lock RACI timelines to support client transparency.
Query Quality Review High frequency of random samples of all query touchpoints to ensure complete accuracy.
Medidata Partner
In place to ensure follow-through, consistency, and reduction of information sharing risk.

Case Study: ARG Rescues Studies Using Holistic Assessments

While considering a mid-study change in CRO is not an easy choice, it can be necessary and effective, especially when sponsors become aware of low quality deliverables or service.

ARG has been challenged with rescuing poorly-conducted trials, which involves infusing a holistic assessment, where expectations are set with up-front transparent conversations.

All transferred projects received an in-depth gap and risk analysis. A full assessment was performed as if the start of the study was initiated at ARG.

First, the protocol was reconciled with the existing database to confirm accuracy of forms, edits, eCRF completion guidelines, skip logic, form rules. Existing SOPs and tools are reviewed.

Second, ARG generated a plan to re-establish how to run the trial to meet expectations. A comprehensive review of the required data and documentations are gathered and reported.

Third, our Data Manager Leads met with study biostaticians to determine the best way forward to produce compliant datasets.

The dedicated team of data managers, clinical programmers and coders use their expertise in re-aligning studies to turn problematic trials into clinical data success stories.

In the end, a complete adoption of the study comes together in terms of both commitment of the team and quality of the deliverables.

Want to chat with ARG about your specific data management needs?

Contact Us Today