Articles

Learn about supporting life science companies with more precise data to for optimized patient-centric care.

Investing in Next-Generation Tokenization and Real-World Data to Unlock a More Precise and Complete Patient Journey

Delivering new treatments faster with a data flow ecosystem

PCM Trials, an independent company headquartered in Denver, Colorado with European operations based out of the UK, brings clinical research to patients wherever and whenever it is most convenient for them. PCM Trials directly recruits, trains, certifies, and manages Certified Mobile Research Nurses (CMRNs) to ensure that each visit meets the highest standards for data quality and patient experience.

Decentralized trials (DCTs) have grown in acceptance since the COVID-19 pandemic when mobile research nurses were asked to step in to save hundreds of site-based clinical trials at risk of being postponed or cancelled because of mandated lockdowns. But despite their proven effectiveness, DCTs are still often an afterthought or an add-on option to site-based trials due to cost concerns

The perception has been that deploying mobile research nurses to visit patients at their own homes would be more expensive than site-based trials. However, a recent study by the Tufts Center for the Study of Drug Development (Tufts) shows that not only are DCTs more patient-centric, but they also provide comparatively high returns on investments for sponsors.

Three Reasons Why Decentralized Trial Models Using Mobile Research Nurses Yield Greater Financial Returns: New Studies Estimate DCTs Deliver More Than a Five-Fold ROI Due to Reductions in Clinical Phase Cycle Times, Decreases in Screen Failure Rates and Fewer Substantial Protocol Amendments

With innovations in wearables, digital monitors and video capabilities, technology can play a role in efficiently capturing data in decentralized clinical trials. Technology alone often is not enough, however, especially considering the diverse and vulnerable populations who participate in clinical trials. Human intervention by properly trained medical professionals such as mobile research nurses is key to ensuring data consistency and integrity as well as protocol compliance. Given the bond that often forms between patients and their caregivers, mobile research nurses also can help improve patient retention. 

Don't Underestimate the Value of the Human Touch in Clinical Trials: Mobile Research Nurses Make a Critical Difference in Decentralized Trials, Whether Employed Exclusively or in Conjunction with Latest Technology

Securing the Integrity of Investigator-Owned Audit Trail Data… It’s Not Just for Sponsors Anymore

Founded in 2015, Decibel is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance. For this growth-stage biotech, Egnyte has been a valuable partner in supporting clinical and regulatory operations, medical writing, biostatistics and data management teams with a single repository for all documentation gathered from CROs and submitted to the FDA and other regulatory agencies. 


Decibel Therapeutics case study 

Drug development has dramatically changed over the past ten years. Specifically, when it comes to GxP compliance and validation. Many biopharma companies struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations.
In this white paper, we will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.


Best Practices for 21 CFR Part 11 and GxP Validation for Electronic Records (Jan 2023)

A Checklist For Building a Scalable Content Architecture in Life Sciences

The biotech uses Egnyte to slash its reliance on manual processes so its team can produce better data quality and accelerate drug development.


Nimbus Discovery Case Study

While it can take more than a decade to bring a new drug to market, each year is filled with many new challenges and complexities. All of this change and uncertainty makes strategy and planning extremely daunting for Life Sciences companies: How do you prepare your organization for the future, without overcomplicating the present? How do you mitigate risk, and maximize agility?
Join a live discussion with Karl Fischer, Sr. Director, IT & Operations at IO Bio which develops leading-edge therapies for the treatment of solid tumors. The company also has several candidates in early phase clinical trials.


All Whitepapers