Clinical Trial Data Management
We Understand Your Data Management Challenges:
- Are you confident of your CRO’s commitment to drive, build and lock timelines?
- Does your CRO support EMR data direct to clinical database collection?
- Does your CRO support remote SDV and virtual clinical trials for our changing landscape?
- Are your protocol amendment database updates completed quickly and seamlessly?
- Does your CRO prioritize CRA and DM collaboration/communication?
- Do your Data Managers understand site priorities in collecting patient data?
Database Builds and Locks are a Partnership of Transparency
Building a database is a cross-functional collaborative effort that brings your protocol to life. At ARG, we understand collaboration requires leadership. Our experienced Data Managers understand the importance of transparency and effective communication when facilitating design of clinical databases.
Our tools and processes set expectations, track timelines and measure quality throughout the life of your trial, while remaining adaptive to change. Source upload design options provide flexibility for remote or onsite entry and monitoring. Equipped with multiple ARG CDISC-compliant form libraries, designed with our Biostats team, ARG DM hits the ground running while keeping end deliverables in mind.
“Clients these days want answers now and I love that ARG DM provides instant data.”
“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. The many mini-progress reports foster enthusiasm and drive the group toward the grand finale.”
Main Data Management Offerings
Subject, eCRF and Data Status Metrics and Reporting
Knowledge of your study status is imperative to make informed decisions. ARG Project Dashboards provide real time DM metrics and trends delivering dependable insight when needed to support projecting next steps.
Custom Listings In-house
Sometimes a specific listing output is needed to pre-review data. ARG programmers are adept in multiple languages, including Python, R, and SAS to support custom study requests.
Dedicated Clinical Data Managers and Programmers
Our assigned DM Leads and Clinical Programmers are dedicated to your project. They work seamlessly together to reflect your protocol in a user-friendly format for fast and efficient site database entry.
Database Build and Lock
ARG database builds and lock timelines are managed and driven by our Data Leads. Database builds are a cross functional, collaborative exercise and our data managers have the experience and tools to keep everyone and every task on track.
Data Management Plan
Data management plans are living documents that need to reflect the expectations of the study. ARG DM Leads understand the priority of documenting study requirements continually to ensure the team has a useful and robust reference tool.
CRA support, Data Review and Query Resolution
Data review and query generation is an ongoing activity that must be timely and efficient in order to support CRA monitoring visits. Our DM Leads understand the need to access monitoring schedules to ensure all data is coded and queries resolved prior to the next visit, whether remote or onsite.
Ongoing Query Quality Review
ARG’s cross functional Query Quality Review (QQR) process ensures all resources generating, resolving or closing queries have QQR assessments multiple times throughout the study. Updated guidance, action plans and follow-ups are put in place to prevent issues and mitigate risk.
Clinical Data Coding
ARG’s coding team works closely with our Medical Monitors to ensure terms are coded correctly the first time. Delays are mitigated by collaborating with the Data Management team to ensure verbatim is clean and complete prior to coding.
External Labs, SAE and Imaging Reconciliation
DM understands that external vendor data must be received and reconciled frequently to ensure endpoint data is collected, regardless of whether it came from a specialty lab or central imaging. We work with vendors proactively and document expectations in transfer receipt and format to ensure seamless reconciliation and data availability.
The ARG Difference
Cross Functional Standard Project Metrics (SPM)
Most companies have internal audits; however, ARG focuses on ensuring that each department at ARG is paying attention to quality standards of their job – especially of our CRAs. For sponsors, this means that at ARG, quality matters for all aspects of a study at all levels.
Remote Monitoring Options Supported by DM
In a rapidly changing landscape, it is vital to be able In a rapidly changing landscape, it is vital to be able to provide proven experience with remote monitoring to support the technology and options that are right for your trial.
- Database design option to upload source for each eCRF to readily provide remote options for both data entry and SDV. Restricted forms roles means no need for PHI redaction.
- ARG DM partnership with Clinical Pipe (EMR mapped to EDC)
Studies Using Holistic Assessments
When a sponsor becomes aware of a project’s repeated poor-quality deliverables or lack of dedicated staff necessitating continued escalation, decisions need to be made. While considering a mid-study change in CRO is not an easy choice, it can be necessary and effective. The challenge in rescuing poorly-conducted trials involves infusing a holistic assessment, where expectations are set with up-front transparent conversations.
At ARG, a transferred project receives an in-depth gap and risk analysis. A full assessment is performed as if the start of the study was initiated at ARG. The protocol is reconciled with the existing database to confirm forms, edits, eCRF completion guidelines, skip logic, form rules and ranges are accurate. Existing SOPs, processes and tools utilized are reviewed, then ARG generates a plan to re-establish how to run the trial to meet expectations. A comprehensive review of the clinical data, coding, queries, external data vendors, site relations, amendments, protocol deviations, project plans and documentation are gathered and reported. Our DM Leads meet with study biostaticians, determining the best way forward to produce compliant datasets.
The DM team works with clients to define timelines, then generate a RACI roadmap to get the project back on track. A KOM focuses on revised goals and metrics to rectify existing issues and challenges. The assigned dedicated team of data managers, clinical programmers and coders work together to 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.