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Do You Have Visibility into Your CRO’s processes?

Do You Have Visibility into Your CRO’s processes?

Do You Have Visibility into Your CRO’s processes?

July 6, 2021

ARG Transparency

  • Provides lines of sight into budgets for cost and time predictability
  • Fosters feedback from stakeholders for constant trial improvement
  • Adds value via communication to refine processes and address challenges

ARG believes that true project collaboration is predicated on genuine transparency. This means more than just open communication. It is about exchanging specific ideas and providing experienced feedback at every step along the journey. The end result for our partners is enhanced and measurable value in their neurology, oncology and immunology clinical trials.

We are cost-conscious, financially responsible, and considerate of budgets, yet understand and clearly communicate how additional activities could add value and reduce time to market.

From the outset, we provide flexible and transparent contracts and budgets, ensure our partners understand costs, and are clear in communicating project assumptions and the change-order process and triggers.

At the end of the site selection process, feedback is furnished on strengths and weaknesses, and assistance as needed is offered. We build relationships with the most dedicated and skilled investigators, then provide robust training to ensure that testing sites will uphold the highest research standards.

We are continually aware of the importance of hitting milestones, so we provide visibility via clear, up-to-date communication on budgets, timelines, protocols, and enrollment goals.

Our transparent communication goes way beyond updates, as we conduct a robust medical protocol review in order to be as safe as possible for patients, address a clear research question, yield the information needed to meet regulatory requirements, and be usable by investigators in the field. Our rare disease, oncology, and immunology focus consistently allows us to provide insights to partners about disease processes and specific patient populations.

Transparency also means that multiple perspectives may need to be considered. In our experience, a best practice is to involve investigators and patient advocacy groups in protocol development. A thorough process for reviewing all aspects of protocol feasibility helps prevent protocol changes and improves site recruitment performance.

It also helps eliminate potential logistical issues (such as scheduling labs and diagnostics) as well as problems that interfere with patient participation (such as difficult-to-open medication packages). Collaboratively coordinating protocol feasibility between all support functions is important to mitigate the occurrence of alterations with unanticipated implications-- like study monitors suggesting the collection of additional imaging results that the database could not accommodate without additional programming.

The ARG mindset at all times is to continually provide not only value to partners, but visibility into our processes as well.

Does Your CRO Understand the Ultimate Trial Goal?

Does Your CRO Understand the Ultimate Trial Goal?

ARG's primary goal is to improve and prolong the lives of the people affected by rare diseases through the clinical trials we manage. We realize our patient-centric approach by carefully cultivating relationships, fostering meaningful communication, and anticipating and addressing all of the challenges in our studies.

May 23, 2019
Does Your CRO Innovate To Keep Trials On Track?

Does Your CRO Innovate To Keep Trials On Track?

ARG knows from experience that the willingness to be flexible has fueled our success in rare disease clinical trials, resulting in approvals with over $3B in sales.

May 9, 2018
Does Your CRO Value Every Single Patient?

Does Your CRO Value Every Single Patient?

Every patient counts. While large-scale intricately-designed studies can afford to lose patients, clinical trials for rare patient populations are not buffered for atrophy. ARG emphasizes that every patient is vital; in fact, we place the utmost importance on every data point in every study.

May 20, 2021