Newsletter | May 13, 2019

05.13.19 -- Getting A Handle On Clinical Trial Costs

  CTMS Market Dynamics And Service Provider Benchmarking

In this report, ISR surveyed 110 qualified CTMS decision makers regarding their insights on topics such as CTMS selection drivers, outsourcing trends, use, and perceptions of providers. Respondents also shared general improvements they would like to see in the next generation of CTMS software and conveyed provider-specific advantages and improvement suggestions for their preferred system. You can purchase the full report or download a free preview by clicking here.

Featured Editorial
Inspire Awards Honor The Industry’s Best
By Ed Miseta, chief editor, Clinical Leader

The DIA Inspire Awards have grown every year that Barbara Lopez Kunz, global chief executive for DIA, has been with the organization. Kunz, who has been with DIA since 2013, notes it has become the place to be for attendees traveling to the annual meeting.

Getting A Handle On Clinical Trial Costs
By Amit Pratap Singh Rathore, principal analyst, Beroe Inc.

Recently, clinical trials have become very complex affairs, especially for small and medium biotech companies. There are many factors behind this, including, but not limited to, increased costs and regulatory requirements. According to Tomasz Sablinski, CEO at Transparency Life Sciences, the cost of clinical trials increased by around 100 percent from 2008 to 2019. A study published in JAMA Internal Medicine in 2018 found that out of 138 pivotal trials assessing 59 new therapies that received FDA approval between 2015 and 2016, there was a more than 100-fold difference in the costs of clinical trials.

Industry Insights
New Opportunities For Immuno-Oncology Clinical Development Programs Through T Cell/B Cell Repertoire Profiling
White Paper | By Victor Weigman, Ph.D., Patrick Hurban, Ph.D., Alan Wookey, B.Sc., and Patrice Hugo, Ph.D., Q2 Solutions

Immune repertoire profiling provides better outcomes for immuno-oncology development programs.

The Data-Driven Reality Of Clinical Trials
Article | By Craig Morgan, goBalto

Understand how metrics provide the foundation for business intelligence for clinical trials, measuring success or failure.

How Services Marketers Can Own Their Performance Measures
Article | By Kevin Olson, Industry Standard Research

Service marketers can take control of their marketing performance by implementing credible marketing effectiveness measures and creating their own narrative.

eConsent Resources Overview
Article | By Jackie Brusch, CRF Health, a CRF Bracket Company

Access to electronic eConsent resources from the past twelve months.

Advancing A Diabetes Multiregistration Program
Case Study | Covance

A large pharmaceutical company asked Covance to support their studies for a diabetes Phase 3 program specifically to register a drug to treat type 2 diabetes. Read how Covance utilized its rich central laboratory services database and helped the sponsor achieve first patient in (FPI) ahead of schedule for all studies in the program and beat historical industry performance across a number of key metrics.

Minimizing Errors And Saving Time In Drug Receipt Processes
Case Study | Thermo Fisher Scientific

The speed/accuracy tradeoff is a well-known phenomenon in psychology for processes requiring human input: The faster you go, the more likely it is that errors will be introduced into the system. This presents a major challenge for complex supply chains that demand both efficiency and accuracy. This case study shows the steps Fisher Bioservices took to improve efficiency and accuracy to combat the complexities of the drug receipt process.

Rare Disease Disorders And CNS Drug Development: Paving The Way For Precision Medicine
Webinar | Medpace

In CNS drug development, more and more diseases once viewed as common are now known to be collections of rare variants. Our deepening understanding of the human genome and pathophysiology has led to fragmented classifications of common neurological or psychiatric disorders based on identified genetic markers.

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