Newsletter | March 25, 2020

03.25.20 -- How One Small Biotech Is Changing The Fight Against Cancer


What characteristics and skills can you develop to improve communication channels with your CROs and sites? Join Clinical Leader Live on Tuesday, April 7, 2020, for a virtual conference examining how your style, approach, and active listening skills can help alleviate the communication breakdown and, in turn, improve trial quality. Register.

Featured Editorial
How One Small Biotech Is Changing The Fight Against Cancer
By Ed Miseta, chief editor, Clinical Leader

Intensity Therapeutics is preparing to kill tumors in a way that has not been attempted before. That effort is also causing challenges with patient recruitment and trial end points.

Preferred Provider Use Among Bioanalytical Lab Outsourcers

In Q32019, ISR asked outsourcers of bioanalytical lab services about their organization’s use of preferred providers. The data shows that the use of preferred providers is common practice when outsourcing bioanalytical lab work; 88 percent currently use a preferred lab for preclinical services and 90 percent currently use a preferred lab for clinical services. On average, respondents indicated that their company currently has 2.3 preferred labs for preclinical services and 2.6 preferred labs for clinical lab work.

Industry Insights
Reporting To The IRB: What NOT To Report
Article | By Lauri Carlile, Advarra

Learn what NOT to report to your institutional review board (IRB) from an IRB operations expert. Many of the "potential" unanticipated event reports IRBs receive don't pertain to IRB responsibilities, and such submissions provide no regulatory or legal coverage.

5 Questions To Ask About Your Clinical Trial Packaging
Article | By Greg Keizer, Bellwyck Pharma Services

By driving your packaging strategies at the onset of a project you can be sure that your packaging aligns with how your trial is planned to be run. While every study is unique, following are questions that should be asked at the beginning of every relationship.

Considerations When Implementing New Technology At Clinical Trial Sites
Article | By KK Rumrill, IQVIA

More than 10 years ago the digital revolution came to the clinical trials industry, ushering in a host of new technologies for sites worldwide. While a few technologies were lauded, many sites found themselves overwhelmed by the sheer number of new offerings and frustrated by the numerous solutions proposed by sponsors that ultimately made trials more difficult. There are many steps that organizations can take to implement a site-first approach to ensure their tools aren’t missing the mark.

Successful BYOD In Any Phase
White Paper | By Gena Gough, with co-authors Kim Romanello and Kyle Hogan, Clinical Ink

The idea of BYOD (bring your own device) for use in clinical trials during any phase has historically been conceptualized as a futuristic alternative, rather than what it actually is — a viable option for many clinical trials. While there has typically been hesitance among sponsors and CROs to choose a BYOD model for their study, there are an increasing number of trials that have successfully deployed this model with great results. Read more about the advantages and misconceptions of BYOD and what you should consider if you are deciding whether BYOD is an option for your study.

Vetting Your Vendor: A Reputation For Success
Article | TrialScope

When researching vendors, particularly in the tech space (and especially in clinical trial disclosure), you should look at more than just the price tag. Do your due diligence. How long has the vendor been in business? What does its client roster look like? What kind of reputation does it have in the industry?

Scaling Biometrics FSP
Case Study | Catalyst Clinical Research

A small biotech was purchased by a large multinational biopharmaceutical company and shortly thereafter closed the office of the former, leaving little to no resources for ongoing statistical programming to ensure continuity for their robust clinical development programs. To ensure limited disruption of the program, the sponsor engaged Catalyst to assume statistical programming services as they had no internal resources to dedicate. With Catalyst proving the ability to scale and provide exceptional programming talent the partnership continues to expand.

Adopting Label Change Best Practices To Promote Clarity And Compliance
Case Study | Almac Group

Globalized clinical trials are quickly becoming a prerequisite for success. Read Almac’s latest case study to learn how one sponsor was able to extend its trial into new countries without risking labeling non-compliance, which enabled them to continue on their mission to improve the health outcomes for millions of patients.

Managing Risks To Time-Critical Product Imports At Clinical Supply Depots
Case Study | Catalent

Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the U.S., an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Israel.

  Remote Monitoring Operations While Maintaining HIPAA And GCP During COVID-19 Restrictions

April 2, 2020 | 1:00 PM EDT

Ensure your clinical trial data quality remains high during COVID-19 travel restrictions. Register for our webinar to learn about FDA’s new guidance on remote monitoring.

Clinical One: Unify Your Clinical Development World
Oracle Health Sciences
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Medical Device Recalls: Keys To Implementing A Successful Approach

April 14, 2020 | 1:00 PM EDT

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