Clinical Operations

Are You Looking for Clinical Operations from a CRO that Will...

Work hard to understand specific therapeutic areas?

Evaluate a protocol from a patient perspective?

Take a proactive and agile approach from start to finish?

Explore ARG’s Clinical Operations services.

Tell Us About Your Study

What do ARG’s Clinical Operations Services Include?

Daily Metrics Refresh

Project dashboard refreshed daily for teams to access data at any time.

Monitoring

Remote, on-site, targeted/risk-based and centralized monitoring.

TMF Maintenance

KPIs from start-up to close-out within eTMF platforms, plus QC of site and general files.

Site Feasibility and Selection

Analysis of site processes and patient population to ensure successful enrollment, SQV, and SIV.

On-Call Audit Support

Regular guidance on site audits before, during and after inspections.

Regular Calls for CRA and CTA Teams

Forums for CRA and CTL teams to discuss pain points, operational issues, and updates.

FM Department Meetings

Forum for managers to discuss project resourcing, department initiatives, processes, and efficiencies.

Quality Oversight Visits

Annual reviews to ensure top-notch CRA performance and end-to-end compliance.

Remote Monitoring

SDV through EMR access, eSource, eRegulatory, and shared folders for review documents related to IP accountability.

Meet an ARG Clinical Research Associate

Stephanie Martynenko

Senior CR Associate

Within the Clin Ops team, each employee has a multitude of therapeutic experience and perspective. The team emphasizes open communication and teamwork, which allows for continued excitement throughout the lifecycle of a project.

Why Choose ARG for Your Clinical Operation Needs?

Executive Accessibility All projects get high visibility within the leadership team.

Commitment to Success All ARG employees are personally and financially vested in the success of your trial.

Stable Core Study Teams From bid defense to close-out, your PM, CTL, and CRS are consistent members of your team.

Cross-Functional Training Close working relationships between PMs, CRAs, Clinical teams and other departments.

Valued Employees Above average tenures for PMs and Clinical Operations, reducing turnover and disruptions.

Automated CRA Transition Form Standard process to ensure follow-through, consistency, and less risk of information sharing.

Case Study: Overcoming Site Hurdles with ARG’s Agility and Technology

ARG was tasked with using a site that was specifically chosen by the sponsor for a retrospective trial. Three challenges became clear.

First, the desired site did not have the clinic research staff to gather the information from their electronic medical records (EMR) and enter it into the database (eCRF).

Second, the site’s EMR did not allow for remote access and only had one terminal available, which was already being used by multiple people at the clinic.

Third, the amount of data entry and monitoring (50 subjects) required multiple people and could not be done simultaneously.

ARG was proactive in addressing the challenges. First, ARG’s IT department loaned the site a laptop that could be used as a portal to the EMR.

Second, ARG provided a trained person to access the EMR remotely and enter data into the study’s eCRF.

Third, ARG resourced team members in time zones that spanned the UK to the US west coast, which allowed access to everyone separately.

ARG was able to complete the retrospective trial successfully. The sponsor was thrilled with our flexible approach that adapted to their needs while getting the project done well and on time.

Want to chat with ARG about your specific clinical operations needs?

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