Smooth Drug Development: How eTMF/eISF solution adds value to Remote Site Monitoring during COVID-19 - PRNewswire

WILMINGTON, Del., March 9, 2021 /PRNewswire/ -- The COVID-19 pandemic has brought major challenges for the clinical trial industry.

We are happy to share that none of clinical trials performed by Smooth Drug Development were paused or cancelled regardless the challenges encompassing a range of clinical trials activities. Why?

The answer is Smooth Drug Development electronic solutions for Clinical Trial Management.

For several years we were moving towards remote site monitoring. Technically we were ready to do that before COVID-19 because a lot of our activities were electronic and partly remote. For example, in addition to contracted EDCs we were widely using our own electronic solutions in our daily pre-coronavirus activities: Quality / Learning / Human Resource / Project Management, Monitoring, ePRO and eTMF in most clinical trials managed by Smooth Drug Development.

One year before the COVID-19 pandemic, we launched our next generation of the eTMF – integrated eTMF/eISF solution. This module allows:

To keep all unique study documents at different levels: general, country, site, and site staff.
To provide unprecedented flexibility of document access for functional roles of Sponsor, CRO and sites.

"It facilitated prompt adjustment to the new reality by expanding remote monitoring in non-COVID trials and by streamlining of start-up of new COVID trials," said Dmitry Morozovsky, MD, EMBA, CEO of Smooth Drug Development.

Smooth Drug Development eTMF/eISF eliminates the time-consuming manual ISF compilation processes such as printing, collection and shipment of paper files to the sites. Now Clinical Operations team can upload study documents to eTMF and all sites' eISFs regardless their locations and time zones within several minutes. Now Smooth Drug Development is able to deploy one-click eTMF binder structures to all sites and add updates versions of documents across all the countries and sites from one place. The receipt and acknowledgment of new documents by sites is confirmed by electronic signatures, it's easy to track the acknowledgment of documents' receipt by sites teams and communicate important information such as protocol amendments in one place to all study teams.

During the study CRAs can easily access sites' study documents from anywhere and anytime. This access allows monitors to complete their work remotely without communication, onsite restrictions, or travel delays, saving significant time, and reducing overall cost.

About Smooth Drug Development

Smooth Drug Development is a full service CRO in Eurasia with advanced technological solutions for clinical studies since 2008.

Media Contact:
Julia Sardaryan
+1-302-660-0614
[email protected]

SOURCE Smooth Drug Development