Building Compliance and Oversight within your study workflow

“myClin has developed a cloud-based tool to simplify communication and task management between trial sponsor, lead investigator, site manager and service providers in between.”

MedCity News

Simple Document Sharing and Collaboration

No need to dig through your overloaded inbox of duplicated, isolated, and non-compliant emails. myClin presents you with a personalized knowledge feed with everything you need to know.  Share documents with your study team on your central and secure myClin channels.

Batch uploading: Upload and share your study materials in seconds

Versioning: The latest document in circulation, always at your fingertips

Commenting: Get feedback easily, keep projects moving and your team in sync

Quick search: Tag and find documents easily

Real-time Oversight and Demonstrable Compliance

Gain a clear picture of what's going on in your study. myClin tracks the delivery of critical study updates when users have read and understood announcements, training, or documents. Based on the study teams interactions, the myClin Compliance Score dashboard provides clear and objective metrics to reveal Compliance blind spots across the entire study.

Continuous Oversight: Automatically track document actions (views, files, downloads, and prints) taken by specific individuals, across all teams

Compliance scoring: View your study Compliance with simple metrics under the myClin Compliance Score, at the site and study level at all times

Evidence of Oversight: Through your normal study activity, automatically generate reliable evidence of your Oversight

Highlight Compliance blind spots: It leads you quickly to parts of your study where Compliance is not so strong (e.g. sites not reading study updates)

Collaborative, Living eTMF and eISF

As opposed to a traditional eTMF, myClin updates all your key study documents and interactions instantaneously. Use your eTMF as an efficient study management tool instead of a simple repository. Build a perfectly organized, inspection-ready eTMF. Optimize document creation by allowing the author to distribute and correctly code items as they go along - cutting out later reconciliation tasks. Documents can appear on one or both the TMF and an ISF simultaneously, as controlled by the author. All stakeholders can access the latest study materials when they need them with automatic proof they have accessed the correct versions.

Networked eTMF and eISF in one: Simplify your site’s eISF management by giving them controlled, auditable access to the parts of the eTMF that matter

Dynamic organization: Capture and code assets instantly. Simply tag and organize your documents for easy review and classification of documents

Reliable, audit-ready eTMF: Record evidence of good study execution on an ongoing basis; automatically generate the Oversight evidence for regulators

eTMF-EMS ready: The eTMF Exchange Mechanism Standard allows TMF content to be moved between eTMF platforms (into or out of myClin)

Successful Safety Report Distribution

myClin has long been used to distribute essential study documents. Safety reports are a specialised but high profile subset of these essential study documents. Alongside their use of myClin for many other capabilities our sponsor and CRO customers have distributed 100s of safety reports to 1000s of sites.

Proof of receipt: Show that the safety report was delivered to sites in a timely manner

Active information distribution: Know who has read your latest SUSAR

Inspection ready: automatic collection of evidence that sponsor is discharging their safety reporting obligation

Compliance Anytime, Anywhere

myClin is accessible in real-time and fully compatible with any device. It doesn’t require any installation and can seamlessly adapt to the size and geographic location of your team.

21 CFR Part 11: myClin is a cloud-based and 21 CFR Part 11 compliant system

Responsiveness: myClin can be used effortlessly on desktop, desktop, tablet, or mobile

Localization: myClin natively supports 47 languages including multibyte character sets and those that read right to left