ARG Papers, Case Studies and Articles

With operational and therapeutic expertise that includes over 300 clinical research studies, we have established multiple resources to help our partners succeed in trial planning and execution.

Download some of our selected white papers, case studies and articles below.

White Papers

Critical Considerations for Rare & Orphan Disease Trial Planning

A Question-First Approach to Rare Disease Studies
Overcoming the unique challenges of rare disease drug development starts with asking the right questions. This paper is a guide to critical questions to ask and best practices to employ when developing and outsourcing rare disease clinical trials. Based on ARG’s decade of consulting around the world, this paper is designed to surface and mitigate the unique challenges rare disease studies present.

In this whitepaper, we address:

  • Is your study protocol optimized for success in the intended population – and for the planned study sites?
  • Is your recruitment plan realistic? Could it be accelerated?
  • Are investigator sites adequately supported to ensure trial quality?

Optimizing Oncology Trials via Remote Monitoring

Specialized Challenges Require Specialized Solutions
Now that highly specialized approaches are driving the oncology drug pipeline, it is critical that your oncology CRO understands the need for specialized approaches to drug development and offers oncology services that will optimize the likelihood of a successful development program. 

In this whitepaper, we address:

  • Remote Monitoring For Faster Source Data Verification
  • Expanding Data Collection Beyond The EMR
  • Provide Methods for Source Documentation That are Simple and Secure

Optimizing Oncology Clinical Development Programs Via Risk-Based Quality Management (RBQM)

How Are RBQM Strategies Integrated Into Clinical Trials?
ARG’s utilization of technology to facilitate the drug development process is apparent by looking at how Risk-Based Quality Management (RBQM) strategies are integrated into clinical trials according to ICH E6 (R2). RBQM employs various technologies to identify signals that indicate potential risks with trial conduct, patient safety or data integrity, for example.

In this whitepaper, we address:

  • The Importance of Identifying Key Risk Indicators (KRI)
  • The Benefits of Centralized Monitoring
  • Gathering Higher Quality Data Without Additional Costs

Patient Centricity in a Consumer Model

Tailoring Clinical Trials To The Patient-Consumer
Consumers today are better informed at least partly due to the evolution of communication and technology – especially in the context of the societal change towards interconnectivity. The expectations that go along with this growing public knowledge base are twofold: consumers expect to meaningfully participate in their purchase experience more than ever, and they also expect a modern customer service experience.

In this whitepaper, we address:

  • Patient-Consumer Participation
  • Patient-Consumer Customer Service
  • The Future of Patient-Consumers in Clinical Trials

Rare Perspectives: Factor X Deficiency

Keys to Clinical Trial Success
Planning for a Factor X (FX) deficiency clinical trial requires more than simply understanding the underlying pathologies of this rare bleeding disorder. This guide is designed to surface and address the unique challenges of FX deficiency to ensure success.
In this guide, we address:

  • How to account for the wide range of symptoms/phenotypes to mitigate treatment risks in FX-deficient patients
  • Which tactics are best for successful clinical trial recruitment
  • How to leverage the Hemophilia Treatment Center (HTC) Model to achieve maximum results for all stakeholders

Case Studies

Case Study: The Journey to Droxidopa

Overcoming Challenges in Clinical Trial Recruitment
Read through the eyes of the investigator, sponsor and CRA who played pivotal roles in bringing droxidopa to the United States. This case study also highlights ARG’s experience and best practices in helping to usher this drug to FDA approval.

The Challenge:
The study sponsor was planning for NOH 301, a phase III trial to examine the clinical effect of droxidopa for people with neurogenic orthostatic hypotension (nOH), a rare disease that causes a sudden drop in blood pressure upon standing. Initially, the sponsor contracted a CRO to manage the study. However, the traditional “large market tactics” employed by the hired CRO were not suited for rare disease research. As a result, patient enrollment stagnated for many months.

The ARG Solution:
Atlantic Research Group (ARG) was chosen to manage the sponsor’s adjunct safety study — NOH 305. ARG’s unique culture empowered their CRAs to proactively think outside-of-the-box, which enabled them to complete patient recruitment within five months. The template used in the success of the NOH 305 study would then go on to help boost enrollment in the lagging NOH 301 trial.

Case Study: Cinryze

A Life-Saving Drug’s Race to America
For people living with hereditary angioedema (HAE), a devastating rare disease that causes severe swelling in many parts of the body, there has been no treatment available in America. Until now.
A small biotech set out to bring Cinryze — an HAE drug previously approved in Europe — to America. Initially, however, the trial did not go as planned.

The Problem:
The first large CRO that managed the trial had 100% CRA turnover, resulting in damaged relationships with key sites. Recruitment stalled.

The ARG Solution:
ARG deployed experienced and strategic CRAs. ARG’s approach empowered CRAs on the front lines of clinical sites to proactively solve novel problems, establish meaningful face-to-face relationships with study coordinators, and spend extra time answering questions. The ARG difference accelerated recruitment and guaranteed the success of this pivotal study — with a 0% CRA turnover rate.

Case Study: Expanding Drug Supply Management Capabilities with Medrio and Veracity Logic

Under a strict timeline and in need of drug supply management, we were searching for a way to bolster our software repertoire. Using a free API from Medrio, we were able to access the comprehensive drug supply management capabilities of Veracity Logic without forfeiting Medrio’s top-shelf Electronic Data Capture. See how we achieved necessary randomization and supply management while meeting strict timeline needs.