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.
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.
Learn about how to still fulfill your common GCP obligations during a global pandemic:
In this session, you get the chance to hear from experienced site coordinators about what sites really think of your study processes. This includes how to keep your study moving during the COVID-19 pandemic.
Sites are highly motivated by the needs of their patients, and relationships with Sponsors work best when these needs can match study processes and objectives. Participating in clinical trials can be difficult, but sites are open to collaboration and new ideas and recognize that they are part of a larger team.
Watch this webinar to hear new and eye-opening insights that will help you better understand and appreciate the site perspective, and ultimately contribute to improving study outcomes.
Watch and learn how to:
Recent regulatory enforcement and ICH E6 R2 updates reaffirm that compliance and oversight are hot topics. Oversight is a responsibility that cannot be delegated by the sponsor. Modern eTMF solutions fail to document readership and versioning (changes over time), while using email and spreadsheets in your study leads to:
In this webinar we examine why blind spots exist and how to resolve your study blind spots with our continuous and contemporaneous solution.
About: Digitization is simply changing from an analog to a digital form. Digitalization, on the contrary, means leveraging technology to revamp a clinical trial conduct model to invoke new value-producing capabilities.
Knowing which version of any important study document is in circulation is critical, but there is more that happens when you know who, when, and how many times a document has been read (or more importantly, not read!). Learn how real-time tracking of your documents, training, and essential study information can help monitor and resolve engagement issues, keep your study on track, and actually help you pilot and manage risk more proactively.
This webinar will help you better understand understand the real-world effects of the digitalization of study Oversight. Hear first-hand from Clinical Operations Leader John Silowsky the operational and organizational impact myClin had on studies he managed.
About: Sharing study information by email? Is it safe? Is it secure? Is it compliant? Understand the risks (and mitigate them).
Email is ubiquitous to our daily life and it is understandable that people think it's fine to share sensitive and confidential information by email. However, the perceived security of email is a mirage. Email is too easy to misuse and lacks controls on information distribution that are standard in other mission-critical clinical trial systems.
Watch clinical trial communication and technology expert, Johnny Bilotta, discuss the truth about the wild and scary world of email.
About: 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. In certain places, you aren't sure how to demonstrate Oversight. Important Oversight tasks can be pushed aside when recruitment lags or when problems are identified and your study team scrambles to provide a fix. As a result, regulators are increasing scrutiny and their expectation around study Oversight is for improved sponsor performance.
This webinar with Kathy Goin, VP, Clinical Operations at myClin/Clinical Works, will help you navigate these new rules and examine how to integrate Oversight within your everyday study workflow. Adam Wood, VP, Business Development, will demonstrate how the myClin platform can help you centralize the collection of trial information to streamline and automate this Oversight process. How to document your Oversight steps.How to automate the tracking of trial Oversight activity without burdening your team with extra work.How to keep a disciplined and consistent approach to capturing trial information, while saving time.
About: To advance science, we need to work together! The Leukemia & Lymphoma Society (LLS) took that statement all the way when it launched the Beat AML study, a ground-breaking collaborative clinical trial to treat AML.
This webinar demonstrates how the myClin platform is connecting leading cancer centers, a CRO, a genomics company and major biopharmaceutical companies. All led by the LLS research team, a non-profit organization.
About: Hear from CEO James Denmark how our next-level collaboration platform helps sponsors better communicate with clinical sites, stay organized and audit-ready at all times.
About: From social media sites to online banking and note taking or sharing, individuals are immersed in an ecosystem of applications where information travels quickly and collaboration in real-time is efficient. This webinar demonstrates how such modern experiences are already being applied to clinical studies to move research forward. Kathy Goin will speak on this topic and show how myClin is helping a growing number of Sponsors and their providers collaborate more efficiently and reach a stronger compliance.
About: Watch this webinar to hear directly from a customer about the value and benefits of myClin. Learn how Trevena used our platform to streamline communication with 75 clinical sites on a 3 study Ph III program.
It’s time to streamline communication and sites engagement!