As COVID-19 increased its impact on research collaboration and monitoring in 2020, Tekton Research’s desire to move to full remote monitoring intensified. The research site soon realized there was a need for a remote source document monitoring solution --– one that would enable the upload, management and sharing of source documents with monitors and sponsors without redacting sensitive patient information.

While electronic document management is becoming more mainstream, it’s still considered uncharted territory for some research sites. The transition is often approached with trepidation, fear, and questions. Over the past several years, we have helped many sites move towards a paperless environment. And in our experience, we’ve found sponsor pushback to be a common concern. To that end, we are offering a few tips to ease the apprehension.

Source document review and verification is an extremely important aspect of this remote monitoring, but also an extremely risky one, as sensitive PHI is shared across virtual organizational walls. Fortunately, there is a very simple solution if the right eRegulatory solution is used. Here are the three primary requirements when looking for a remote source document review solution.

Working at a clinical research site can be stressful; from managing patient appointments to tracking study documents, professional tools designed to simplify tasks and improve productivity are critical. A clinical trial management system (CTMS) can streamline the daily activities and boost the overall financial health of clinical research site.

Billing compliance is a highly prevalent matter in research administration. As such, institutions are continually looking for ways to ensure compliance, one of which is coverage analysis.

Coastal Pediatric Research (CPR) was well aware of the eRegulatory trend that was surfacing. Before CPR selected a platform, the team gave some thought to what they wanted an eRegulatory system to contain and/or provide. Learn more about the criteria for their selection and what solution met their criteria.

No human endeavor is immune to change, and that is certainly true for clinical research. John Neal, CEO of PCRS Network, spent a year talking to sponsors, management, and other various roles in clinical research in an effort to identify the factors that are shaping the future of clinical research. And while the views vary, one factor looms above all others.

Regulatory compliance represents an increasingly demanding and difficult task for investigative sites. A recent survey comes at the perfect time to quantify this burden, identify the infrastructure to manage this burden as well as provide practical opportunities for improvement based on best practices.

As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.

As a stakeholder in a research facility the prospect of an inspection by the US Food and Drug Administration (FDA) may elevate your blood pressure and induce feelings of panic. But according to Dr. Harvey Arbit, "the FDA inspection process should go quite smoothly if you're doing everything right." Still nervous? Don't be.

This podcast highlights how two companies collaborated on a master trial to drastically improve site startup speed, reduce delays, and optimize CRA productivity. Rick Arlow, Complion, and Dr. Len Rosenberg, Leukemia and Lymphoma Society, discuss their collaboration on an LLS master trial, and how adopting Complion’s purpose-built design optimized site functions and reduces startup time.

In this podcast, Rick Arlow, CEO of Complion recently spoke with DPHARM quarterly newsletter writer, Danny McCarthy, to discuss why he believes that the traditional model for site monitoring doesn’t serve the industry anymore and how a purpose-built approach could free up valuable CRA time and reduce costly delays and amendments.

From ACRP’s ExpoTV, Rick Arlow, the founder and CIO of Complion talks about the first to market eRegulatory Document Management solution and how it greatly increases staff productivity and delivers massive time reductions achieving a constant state of audit readiness.