Insights On Clinical Technologies

1. Scaling A Solid Tumor Study 1/2/2020

   A mid-sized multinational biopharmaceutical company opted to internalize the study management and execution of their Phase Ib/II multicenter oncology program. As a result of positive treatment outcomes, patients continued in the trial for significantly longer than originally projected, creating a large data backlog that required source document verification. Read how strategies were deployed to obtain data currency and obtain management oversight to meet the program's expansion.

2. Mitigating COVID-19 Risks In A Complex, Fast-Moving Pain Program 8/19/2020

   A cutting-edge biotech was running a program with three active, concurrent, pain studies across 25 sites and 218 patients, with interim database locks scheduled during the summer of 2020 and final database lock deadlines looming close behind. The COVID-19 pandemic put that all on the line.

3. Applying Biomarker Driven Strategies In Drug Development 4/16/2019

   Determining appropriate stratifications and relevant clinical endpoints for specific sub-populations can be challenging. Therefore, it is necessary for development strategies to incorporate explorations and determinations of suitable biomarkers early in the development of a new therapy.

4. How To Assess the Health Of Your Trial Management Operations 1/13/2020

   In this post, we’ll help you gain insights into your current trial management operations, so you have a starting point to make a case for change for a modern CTMS at your organization. Here is a checklist to analyze the maturity of your current trial management operations.

5. 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.

6. Kickstart Study Start-Up Performance: Insights From Allergan And Johnson & Johnson 2/25/2020

   Allergan and and Johnson & Johnson share how their organizations leverage Vault Study Startup to maximize efficiency and effectiveness.

7. A CRO’s Road To ePRO Revenue 3/6/2020

   A global, full-service CRO had looked at the increasing demand and expected growth rates for electronic patient reported outcome (ePRO) technology and determined that the opportunity for an ePRO offering would be significant. This case study describes how a global CRO successfully added ePRO to its service offerings enabling them to provide a unified service to its sponsor clients while creating a new revenue stream for themselves.

8. Handling Complexity In GI Trials — A Purpose- Built eCOA/ePRO Solution: The GI Library 7/14/2020

   The accelerating complexity of gastroenterology protocols has exceeded the capacity of most electronic clinical outcome assessments (eCOAs) — including both electronic patient-reported outcomes (ePROs) and clinician-reported outcomes (ClinROs) — to adapt. Patients are overwhelmed, sites are overburdened, and sponsors struggle with data quality and integrity.

9. Regulatory Inspection SOP Checklist: How to Prepare for an Inspection 7/12/2019

   A best practice for inspection preparation is a standard operating procedure (SOP) that codifies the roles, procedures, and training your organization will enact in preparation for an announced inspection.

10. 5 IRT Trends To Watch 12/3/2019

    Next generation IRT continues to evolve from work horse to racehorse – with the power to keep pace with rising clinical trial complexity and efficiency demands. Following are five IRT trends and how they will affect the clinical trial landscape.