Newsletter | May 11, 2022

05.11.22 -- Don't Neglect This Drug Development Milestone: The Pre-IND Meeting

Featured Editorial
Industry Insights
Simplify And Streamline Study Builds

“The whole build process is much faster and much easier for everyone involved.” With Vault EDC, discover how to streamline the study build process and reduce lead times for oncology trials.

The CTMS Gap: How Systems Forget About Study Managers And Cras (And How To Fix It)

Watch the available webinar to learn the top ways study managers and CRAs are let down by existing systems and what should be considered so these critical team members have what they need, where and when they need it, to effectively and proactively manage clinical trials.

An Overview Of Approaches To Privacy-Preserving Data Sharing

This post will focus on the landscape of privacy-preserving technology and approaches to protecting privacy during those data flows.

Communicating Value To Providers And Payers

The one-time, front-loaded costs of cell and gene therapies have necessitated new payment models to win payer approval and be affordable. Drs. Emma Medin and Jamie Kistler offer some best practices for telling a resonant value story.

Optimizing Immuno-Oncology Clinical Trials For Biotech Companies

For biotech companies developing an immuno-oncology (IO) therapy, the complexity of oncology clinical trials takes on new dimensions. Review the current IO landscape and considerations for biotech companies preparing for IO studies.

Gene Deserts May Hold An Oasis: A Cure For HIV

In this blog, learn how the HIV virus hides its DNA in remote stretches of the human genome known as “gene deserts.”

Quality Metrics: How To Add Value And Meet The FDA's Expectations

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. 

Featured Editorial
Industry Insights
Why eCOA Data Reporting Often Falls Short (And What To Do About It)

By nature, eCOA and ePRO solutions are designed so that it’s easy for clinicians and patients to provide clinical trial information. But this is only part of the equation. Discover how eCOA and ePRO solutions also need a thoughtful back-end experience. 

Regulatory And Cost Implications For Switching Injectable Delivery Formats

Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy that provides cost-effective solutions, supply chain continuity, and patient benefits. 

The Ultimate Guide For Scenario Planning

This webinar presents the ultimate guide to scenario planning through modern technology as a way to inform clinical supply decisions. 

TMF Reference Model Q&A

The TMF Reference Model is at a tipping point. How will the model evolve to help manage increasing trial complexity and compliance demands? Watch the “Ask An Expert” session on demand with the co-founders of the TMF Reference Model, Karen Roy and Lisa Mulcahy.

Elite Learning Series: Solve Clinical Trial Enrollment Struggles With Better Utilization Of Healthcare Data

This webinar will feature industry leaders from the U.S. Food and Drug Administration (FDA), Freenome, Cerner Enviza, Deep Lens, and Elligo Health Research®. The discussion will also explore potential pitfalls of healthcare data as well as solutions and strategies for overcoming them.

Enabling Personalized Medicine Through Big Data

While the term has been used more frequently in recent years, personalized medicine is not a new concept; healthcare professionals have been tailoring treatments to an individual’s specific needs since the advent of medicine. However, the groundbreaking advancements being made today allow us to understand a patient’s potential susceptibility to certain diseases, and their predicted response to treatments. Facilitating this shift is the availability of Big Data.

Industry Insights
Turn Your EDC Into eSource

Find out why the benefits of capturing data in real-time electronically are manyfold for both sites and sponsors.

Simplifying Oncology Trials: Decentralization For Oncology Trials

Find out why bringing the on-site experience into patients' homes can make clinical research, and therefore treatments, work for everybody.

Keys To Successful Risk Management In Clinical Trials

Effective risk management recognizes variables unique to each clinical trial while embracing consistent documentation practices, stakeholder responsibility, and best practices informed by experience.

Specialized Scientific Support Streamlines Clinical Trials

Achieving appropriate scientific oversight and thorough and efficient sample management throughout studies are challenges that many pharma and biotech companies encounter. In this Q&A, explore a highly specialized outsourcing model that addresses these challenges.

FAQs: In Vitro Diagnostic Medical Device Regulation

On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Discover answers regarding the expected changes in this blog.

Clinical Trial Management In A Post-Pandemic World

A survey was conducted to understand the adaptations that have been made to clinical trials and their effects. The available research results provide valuable insight into the lasting and positive impact of the adaptions made during the pandemic and reveal an industry embracing change.


In this webinar Pro-ficiency's chief learning officer, Beth Harper, will explore why the traditional site training process breaks down and introduce simple actionable ways to make this more effective. She'll share insights and lessons learned from her extensive experience troubleshooting and rescuing clinical trials and discuss how Pro-ficiency is disrupting the process with their simulation-based approaches.

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