ARG’s database builds and locks are a partnership of transparency.Tell Us About Your Study
Project dashboards that provide real-time metrics that inform dependable insights.
Programmers adept in Python, R, and SAS to support custom study requests.
Collaboration to reflect protocols in user-friendly formats for efficient database entry.
Cross-functional efforts led by DMs who have the experience to keep every detail on track.
Regularly updated documentation of requirements to ensure teams have a useful tool.
Accessible monitoring schedules to help teams code data and resolve queries before next visit.
Cross-functional QQR process that proactively prevent issues and mitigate risk.
Collaboration between coding team and Medical Monitors to ensure correct coding of terms.
Reconciliation and data availability through strong vendor relationships and documentation.
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.
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.