On-Demand Webinars

Inspection Perspective — Tales from a Recent FDA Inspection

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.

Learn about:

  • How this sponsor overcame a rough monitoring and documentation situation.
  • What inspectors are seeking about Oversight evidence
  • Their thoughts on the processes and systems used for the Trial Master File and the Investigator Study File (ISF)
  • Practical steps you can take to protect your study / clinical asset even if things go awry
  • Why myClin played a crucial role in "documenting the story of the study" and aiding successful navigation of that inspection.

ClinOps Perspective — So, Oversight When You Can't Visit Sites, Eh?

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:

  • The gap between your study protocol and my clinical practice reality
  • What is good (or bad) about operational practices during the pandemic
  • Examples of poor study processes - and how to avoid them yourself

Site Perspective — What sites really think of your study processes

  • The gap between your study protocol and my clinical practice reality
  • What is good (or bad) about operational practices during the pandemic
  • Examples of poor study processes - and how to avoid them yourself

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.


Uncover Study Compliance Blind Spots with the myClin Compliance Score

Watch and learn how to:

  • Ensure all your parties always have the correct, up to date study information
  • Track team interactions (views, prints, and information acknowledgments)
  • Record evidence of good study execution on a contemporaneous basis
  • Resolve compliance blind spots in your study with the myClin Compliance Score

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:

  • Major compliance blind spots
  • Reduced efficiency in sharing information
  • Uncertainty of document readership

In this webinar we examine why blind spots exist and how to resolve your study blind spots with our continuous and contemporaneous solution.


Start Digitalizing, Stop Digitizing your Study Oversight

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.


The Hidden Liabilities of Using Email for Clinical Trial Communications

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.

  • Become better informed about the visible and hidden liabilities of email
  • Make educated judgments about how you and your team use email during your clinical activities
  • Consider alternative solutions to mitigate risks

Meet the Modern Oversight: Simple & Automated

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.


Unified Collaboration & Quality for a Paradigm-Shifting Study: Beat AML

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.

  • How did the LLS rethink traditional Clinical Operations to make this Master Trial possible?
  • How are teams from many organizations with their own practices and cultures collaborating on myClin?
  • How is myClin digitizing and facilitating massive cross company training?
  • How is myClin building quality management and compliance directly within the communication flow?
  • What are the lessons learned from this Master Trial that can be applied to your own clinical program?

Share it. File it. Track it. Find it.

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.

  • Share it. Learn how to streamline and secure your communication with sites and study stakeholders. Allow for a less interruptive and more insightful review process.
  • File it. Walk through our enhanced user interface and our mission-critical “File It” feature to stay audit-ready and allow for a real-time trial oversight.
  • Track it. Help sites help you succeed in your clinical program. Monitor training and information transfers, measure sites engagement and ensure compliance.
  • Find it. Make sure the study team can access and stay on top of important files with "Easy Documents", quick links and new enhancements around your electronic study files.

Modernising Study Team Collaboration: Catch up with what your sites are already doing

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.


Streamlining Communication & Site Engagement

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.

  • Cut through the noise and allow for an efficient sponsor-site collaboration.
  • Break free of congested email chains and outdated manual files at clinical sites.
  • Aid all study partners (CROs, suppliers etc) in the on-boarding, training and communication process.
  • Shorten review cycles and allow for stronger consensus.
  • Demonstrate to an inspector/auditor the quality of your study management processes.

It’s time to streamline communication and sites engagement!