Every Project Matters
We Understand Your Clinical Operations Challenges:
- Does your CRO go to great lengths to understand specific therapeutic areas?
- Does your CRO evaluate a protocol from a patient perspective?
- Does your CRO care about site success?
- Do your Project Managers take on client goals as their goals?
- Does your CRO provide the right resources at the right time based on your study needs, or just tell you they have 80 CRAs available?
- Does your CRO actually prioritize your study, or just tell you they do?
- Is your project team proactive and agile?
Prioritizing Patient Experiences, Site Relationships and Client Collaborations
ARG Operations constructs a custom-built solution for your project executed by a team of elite professionals. To do so, we begin with a mindset of curiosity, patient-centricity and shared responsibility. We understand the individualized environment of implementation of a protocol in real-world settings at the PM, CTL, and CRA level. Our project team asks questions about what a day in the life of a patient looks like, and how that translates into risk mitigation. From there, we navigate a competitive site landscape to get our studies prioritized, and this only comes with positive long-standing site relationships.
Our PMs serve as study “hubs”, sharing information cross-functionally with both internal and external team members, driving cross-functional real-time dashboard reporting. These tools allow us to support virtual clinical trial (VCT) management. Data-informed, agile, and scalable, ARG Operations sees ourselves as the operational arm of the sponsor there to realize collective goals.
“I need to be continually agile and adjust as things develop that need my attention.”
“The melting pot of experiences that the Clinical Operations team brings to the table is definitely unique and valuable for sponsors. Everyone within the department has such a diverse background and ARG, as a company, is really great at being open and listening to their staff at all levels. It allows for different perspectives and different ways of managing tasks.”
Main Clinical Operations Offerings
Daily Metrics Refresh
Standard project metrics are refreshed daily for all projects so the teams have the ability to focus on the data that matters at any given time for their projects.
Remote, on-site, targeted/risk-based, and centralized monitoring.
KPIs during start-up, maintenance, and close-out within eTMF platforms; quarterly QC of site and general files.
Site Feasibility and Selection
Feasibility to understand site processes and patient population to ensure successful enrollment; SQV and SIV which can be done remotely or in person.
Site Support During Audits
Preparing sites for an inspection and providing support to answer questions, provide guidance, etc during and after an inspection.
Quarterly CRA Calls
Forum for the CRA team to discuss potential pain points or other topics that impact their operations, as well as share updates and reminders that will impact them over the next quarter.
Monthly CTL Calls
Forum for the CTL team to discuss pain points and other topics that impact their CRAs or job function, as well as share updates and reminders that will impact them over the next month.
FM Dept Meetings
A forum for managers within PM and ClinOps to discuss project resourcing, department initiatives, processes and efficiencies that impact operations.
Quality Oversight Visits
Conducted annually on all CRAs to ensure they are meeting ARG’s expectations in the CRA role; QOV assesses compliance with regulations, guidances, processes, project-specific documents (e.g. protocol), and efficiency.
Involves a “see one do one” model for all types of visits.
SDV through EMR access, eSource, eRegulatory, and shared folders for review documents related to IP accountability.
The ARG Difference
and Technology Overcome Hurdles at Site Level
ARG was tasked with using a site that was specifically chosen by the sponsor for a retrospective trial. Although the desired site did have the number of patients to provide a large amount of study-specific data, the primary challenge was that it did not have the clinic research staff to gather the information from their electronic medical records (EMR) and enter it into the database (eCRF). The second challenge was that their EMR system did not allow for remote access and they only had one terminal available for this work, which was already being used by multiple people at the clinic. The third challenge was the amount of data entry and monitoring (50 subjects) that needed to take place.
ARG was proactive in addressing the challenges. First, ARG IT 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, through the laptop, and was able to enter data into the study’s eCRF, just like a site coordinator would. Lastly, the amount of data to be entered and monitored was going to take multiple people, but could not occur simultaneously. Therefore, the work was resourced with team members in time zones that spanned the UK to the US west coast, which allowed access to everyone separately.
ARG is known for its flexible, adaptive approach, and this was an example of being creative and allowing for a different method of data entry. Moving forward, when we are faced with inexperience at the site level, we know that we will still find a way to get the project done on time. The keys to operating without a blueprint are to seek answers to questions, collaborate, stay committed, and leverage our industry-leading tools and technologies.