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Does Your CRO Understand the Ultimate Trial Goal?

Does Your CRO Understand the Ultimate Trial Goal?

Does Your CRO Understand the Ultimate Trial Goal?

May 23, 2019

ARG Patient-Centricity

  • Nurtures relationships with (rare disease) advocacy groups
  • Innovates with our "Study champion" model
  • Understands and addresses human factors

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 also focus on patients afflicted by oncology and immunology disease-states. We realize our patient-centric approach by carefully cultivating relationships, fostering meaningful communication, and anticipating and addressing all of the challenges in our studies.

Patient advocacy groups offer irreplaceable value in rare disease drug development programs; therefore, we nurture partnerships with advocacy groups that have first-hand knowledge of how a condition affects patients and best understand the needs of their community.

Together with patients, we learn about the advantages and drawbacks of existing therapies, and the emerging possibilities moving forward.  We believe that advocacy groups should be engaged early in the clinical development process and be retained beyond the end of studies.

There are unique issues when working on rare disease and decentralized oncology and immunology clinical programs. ARG takes a novel approach and employs the use of a “Study Champion.” The Study Champion is a direct liaison between the investigator, home health nurse, central laboratory, and sponsor-- providing amplified organization, engagement, and motivation.

We are keenly aware that clinical development often involves children, which introduces regulatory, operational, and ethical issues that can complicate recruitment and retention. Patient safety is everyone’s number-one priority, and thus protocols require careful collaboration with experts and other regulatory bodies to minimize trial burden and risk.

For certain clinical trials, we leverage our longstanding relationship with a home healthcare provider to administer drug-infusions, perform blood draws, or carry out other clinical tests. These visits are patient-centric because they help ease the challenges of long-distance or even in-town commutes.

ARG is focused on improving the lives of patients from the outset to the conclusion of trials. We formulate easy-to-reference visit schedules so patients understand their commitments. Patient-friendly terminology can help relieve unintentional linguistic barriers. We also take into account that rare conditions often create disparities in income and employment status, which are compounded by the expense of medical care and lifestyle adaptations.
Every patient deserves to be well, regardless of the rarity of the disease.

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
Is Your CRO a Genuine Operational Partner?

Is Your CRO a Genuine Operational Partner?

ARG's history of successfully operationalizing rare disease clinical research has been driven by comprehensive engagement with our sponsors.

April 6, 2018