Explore ARG’s Clinical Operations services.Tell Us About Your Study
Project dashboard refreshed daily for teams to access data at any time.
Remote, on-site, targeted/risk-based and centralized monitoring.
KPIs from start-up to close-out within eTMF platforms, plus QC of site and general files.
Analysis of site processes and patient population to ensure successful enrollment, SQV, and SIV.
Regular guidance on site audits before, during and after inspections.
Forums for CRA and CTL teams to discuss pain points, operational issues, and updates.
Forum for managers to discuss project resourcing, department initiatives, processes, and efficiencies.
Annual reviews to ensure top-notch CRA performance and end-to-end compliance.
SDV through EMR access, eSource, eRegulatory, and shared folders for review documents related to IP accountability.
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.
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.