Newsletter | September 4, 2019

09.04.19 -- The Keys To A Successful Training, Change Management, & Support Program

Featured Editorial
The Keys To A Successful Training, Change Management, And Support Program
By Ed Miseta, chief editor, Clinical Leader

Implementing a new technology presents many challenges for companies. There is the implementation itself, the training of users, managing the change, and, finally, providing support to users. A panel discussion at the 2019 Oracle Health Sciences Connect conference tackled these challenges, providing advice on how to manage all facets of a new technology implementation.

2018 To 2023 Edition Of The CRO Market Size Projections

Since ISR first put out their CRO Market Size projections, there have been several other reports produced, with surprisingly similar figures. Some of these have future growth rates for the CRO market as high as >10 percent, and some have them as low as ~5 percent. We are somewhere in the middle. ISR is projecting a CAGR from 2018 to 2023 of 7.5 percent. Remember that a lot can (and will) change between now and 2023, but we believe the fundamentals are in place for a growing outsourced clinical development market.

Industry Insights
Seven Essentials For Successful Drug Development
White Paper | By Jack G. Modell, M.D., and John H. Greist, M.D., Rho

In reflecting on the differences between successful and unsuccessful clinical trials or programs, several factors consistently emerge as essential components of success and failure. This article reminds of the essentials so that effective therapies have a greater likelihood of reaching patients in need.

Cut It Out: The Role Of Gene Editing Technologies In Combating HIV
Article | By Bruce K. Brown, Ph.D., Thermo Fisher Scientific

Despite the public attention and large population impacted by this virus, developing a cure for HIV has been particularly difficult. To successfully cure an infected individual the virus would need to be fully eradicated from their body, which is difficult because HIV is extraordinarily good at hiding in a person’s cells. 

Thinking Pragmatically About The Future Of Real-World Evidence
Article | By David Thompson, Ph.D., Syneos Health

Questions and concerns as the FDA prepares to develop and implement a program evaluating the potential use of real world evidence (RWE) for regulatory decisions.

Quality Metrics: How To Add Value And Meet The FDA's Expectations
Article | Ropack Pharma Solutions

Quality metrics have been widely used in the pharma industry to monitor quality systems and operational processes, and to promote continuous improvement initiatives in drug manufacturing.

Reduce The Cost Of Post-Market Surveillance With Real-World Data
Article | ICON Plc

As with every aspect of clinical research, the cost of post-market surveillance and other post-approval studies is rising fast — and in some cases, exceeds projected revenues. This article will explore why post-marketing costs are rising so quickly, and how starting real-world date (RWD) collection early in the device development cycle can reduce post-market delays and save money.

Innovative Oncology Trial Designs In Practice
E-Book | Cytel

A CRO’s strategic consulting group helps clients create and apply innovative trial designs within an exploratory and confirmatory oncology development.

Q&A With RA Imaging Expert Dr. Sharmila Majumdar
Q&A | Medpace

Dr. Sharmila Majumdar, Ph.D., professor and vice-chair of research in The Department of Radiology and Biomedical Imaging at University of California San Francisco, shares her thoughts with us about imaging in rheumatoid arthritis. She addresses the differences between osteoarthritis and rheumatoid arthritis and how they influence the type of imaging we should use, the best imaging modality for RA diagnosis or progression of the disease, as well as the future for imaging in clinical trials for RA therapeutics.

  Festival Of Biologics 2019

October 15 to 17, 2019 | Basel, Switzerland

The Festival of Biologics 2019 will address the strategic and commercial aspects of discovering, developing, and bringing new biologics to patients with high-level, global speakers from Big Pharma, biotech, academia, and industry. We will bring you three days packed full of top-level science, data and case studies, workshops, roundtables, and networking opportunities. With 350 speakers and 1,500 attendees, this is an event not to be missed.

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