White Papers

1. Vital Tools For Centralized Statistical Monitoring Of eCOA/ePRO Data 8/10/2020

   As the industry moves to adopt patient-centric approaches to clinical trials, there is an opportunity to adopt the best practices of QbD and risk-based methodologies to ensure that patient reported data are effectively being monitored. In this paper, we discuss the value of using advanced technology — specifically Centralized Statistical Monitoring technology - to oversee subject safety and data quality/integrity in a risk-based manner.

2. Innovations In Clinical Trial Imaging – 2020 And Beyond 8/10/2020

   Advancements in clinical trial imaging are largely due to the application of Artificial Intelligence (AI) and Machine Learning (ML) to imaging systems and data platforms. Automation is improving virtually every stage of the imaging workflow. Sponsors can benefit from improved compliance with privacy regulations, stronger data quality controls, more accurate and efficient imaging reads, and advanced data analysis for improved decision making. The following paper outlines some of these advancements that are in various stages of development, some of which are available today and others expected to be in operation in the near future.

3. Adaptive Trial Designs In Early Oncology: Minimizing Risk & Accelerating Timelines 7/28/2020

   With the emergence of personalized medicine, we are seeing a shift in how early-phase oncology trials are conducted, including a growing number of Phase 1 trials reporting preliminary response rates. This shift is due in part to an increase in adaptive trial designs that seek to limit the number of patients exposed to ineffective doses or treatments while accelerating the timeline to the detection of efficacy signals. In this white paper, we address clinical trials in personalized medicine and explore the expanding role of adaptive trial designs in Phase 1 and Phase 2 oncology studies.

4. Addressing Cultural Fit With Outsourced Resources: How Can You Find The Right Match? 7/27/2020

   In order to make any outsourcing model work effectively, it is essential to evaluate and match both the skill set and the cultural fit of the candidate and sponsor. This article will discuss strategies for finding the best cultural match and the impact it can have on implementing a successful FSP model.

5. Pharmacy Services In A Phase I Clinical Research Unit 7/20/2020

   This white paper discusses the role of the pharmacy in a modern day Phase I clinical research unit and its role in understanding the safety and pharmacology of a drug before Phase II can begin.

6. Ensuring Access And Approval For Innovative Therapies In Scleroderma 7/20/2020

   Clinical research and development programs for innovative therapies in scleroderma must accommodate the diverse data needs of multiple stakeholders. This white paper explores the requirements to create an integrated program capable of demonstrating the “value” of a new product, as well as clinical utility and therapeutic novelty.

7. Expanded Access And Commercial Packaging Strategies For Orphan, Niche, And Low-Volume Drugs 7/20/2020

   Most commercial contract drug packagers do not provide consistent scheduling for low-volume drugs, which creates supply challenges. In fact, a drug packaging delay can create a market shortage that triggers serious health consequences for patients who rely on the drug. This issue can arise with niche and orphan drugs, as well as any other drugs packaged in small volumes. Conversely, a clinical supply partner can provide packaging as needed, plus handle distribution for expanded access and general commercial needs. This summary describes low-volume drugs, examines commercial packaging and supply challenges, and explores potential solutions.

8. Clinical Relevance Of Measuring Resting Heart Rate 7/13/2020

   Resting heart rate (RHR) is the number of times the heart beats per minute when at rest, in a neutrally temperate environment without any recent exertion or stimulation. Resting heart rate may change with age and has been identified as both a risk factor and a modifiable treatment outcome, especially in lifestyle-related chronic disease. Monitoring RHR and prevention of long-term increases in RHR may aid to reduce the risks of adverse health outcomes.

9. The Growth Of Phase IV Trials And The Need To Demonstrate Effectiveness Using Electronic Patient Reported Outcomes 7/10/2020

   Pharmaceutical companies must now satisfy the value perceptions of multiple stakeholders, including payers, to attain market access for products. This paper therefore seeks to address and describe the growing need to satisfy the value perception of multiple stakeholders and the importance of Late Phase trials capturing Clinical Outcome Assessments (COA) and specifically electronic Patient Reported Outcomes (ePRO) in relation to this.

10. Clinical Relevance Of Measuring Respiratory Rate 7/10/2020

    This paper outlines the importance of measuring respiratory rate and explains how respiratory rate is assessed from photoplethysmography. New technology now enables a wrist-worn wearable device that measures and provides respiratory endpoints including respiratory rate and resting respiratory rate.