Learn how to include local site reality in how you design your study. In this session you will get the chance to hear from experienced site coordinators about what sites really think of your study processes. This will include how to keep you study moving during the COVID-19 pandemic.
So, Clinical Operations when you can't actually visit your sites! As if running international GCP trials wasn't complex enough suddenly we can't visit sites like we are used to.
The expectations of regulatory inspectors are rising over time - requirements are getting tighter and sponsors are expected to make better use of their systems and data. Our speaker has very relevant experience from hosting an FDA inspection (2019) where this reality was clearly illustrated.
To advance science, we need to work together! The Leukemia & Lymphoma Society (LLS) launched the Beat AML study. This webinar demonstrates how the myClin platform is connecting leading cancer centers, a CRO, a genomics company and major biopharmaceutical companies.
Oversight activity needs to be documented on a continuous basis as clinical studies proceed through planning, execution and closeout. Well said. That’s the theory. In the real world, Oversight often comes as an additional workflow, a disruptive force that can sometimes slow down your study.
Read this paper from our Use Case Series to understand how myClin can not only streamline the communication with clinical sites, but also dramatically increase engagement and compliance. myClin can positively impact the study execution while providing with the best documented, data-driven clinical trial oversight.
myClin, the leading Clinical Trial Knowledge Platform, allows for sponsors to connect more closely with investigators and other investigative site staff in a collaborative, secure, and efficient manner. One specific application of myClin is to set up and support Key Opinion Leaders (KOL) Communities.
As a single and secure collaboration channel, the myClin platform can streamline and accelerate protocol development while keeping all parties in sync. On myClin, reviews occur in parallel with everybody seeing contributions from other team members. This dramatically shortens review cycles by allowing participants to work together and build a stronger consensus around the protocol.
This paper provides a modern definition of oversight and what it involves, and illustrates how the myClin platform builds a strong oversight directly within your study team communication and collaboration channels.
Regulatory scrutiny in clinical research has intensified in recent years, and there are no signs that the intensity of the regulatory environment is abating.