Why myClin?

Today, 73% of clinical trial professionals* state evidence of Oversight as the most common gap in study Compliance.

myClin solves this challenge by serving as a central hub for all study documentation, automatically making Oversight part of your day-to-day activities, while keeping your study inspection ready at all times. The myClin Compliance Score measures your study teams’ activity to track and unveil blind spots for future improved compliance.

*Source: myClin 2020 Survey.

myClin enhances your study and breaks down barriers to open channels of communication between sites, sponsors, and CROs. It ensures optimal collaboration on essential study activities like site start-up, training, staff on-boarding, SUSAR reports; keeping your materials up to date and staying inspection ready. The myClin Compliance Score provides recommendations to close gaps in your study Compliance, offering a new approach to more seamless Oversight.

Email vs. myClin

With myClin, you can be certain the essential study materials are received and opened. With built-in version control and chain of custody tracking, you are always audit-ready.

COST
EFFICIENCY
COMPLIANCE
COLLABORATION
Email
  • Chronic Inbox overload
  • Multiple addresses for a single user
  • No transparency
  • Non compliant
  • Insecure, open system
  • Uncontrolled forwarding
  • Frequent source of deviations
  • Use of obsolete attachments
  • Uncontrollable email threads
  • Medium
  • Subscription model
  • Cost per site (not per user)
  • Streamlined document control
  • Built for clinical trials
  • Deploy in 2 hours
  • myClin Compliance Score
  • Fully compliant and pre-validated for
    ICH GCP E6(R2), EMA Annex 11 Sec 4,
    EU GDPR and FDA 21CFR11
  • Easy sharing, discussion & versioning
  • Readership and engagement data

Traditional eTMF vs. myClin

myClin serves as a single source of truth, providing continuous and contemporaneous auditable information.

COST
EFFICIENCY
COMPLIANCE
COLLABORATION
Traditional eTMF
  • High per user licenses/subscriptions
  • Substantial deployment costs
  • Distinct & siloed at each organization
  • Complex user management
  • Limited or zero integration with site ISFs
  • Compliant with significant customer effort
  • Not optimised for collaboration, e.g.
  • brittle workflows unsuitable for all parties in the trial, or for the specific nuances of your next trial
  • Ambiguous stewardship/ownership of stored documents
  • Subscription Model
  • Medium cost per site (not per user)
  • One global platform for all parties in the trial
  • Simple, community managed membership
  • Deploy in 2 hours
  • myClin Compliance Score
  • Fully compliant and pre-validated for
    ICH GCP E6(R2), EMA Annex 11 Sec 4,
    EU GDPR and FDA 21CFR11
  • Easy sharing, commenting, and versioning
  • Role based controls for TMF classification and approvals

Shared network folders vs. myClin

myClin is as user-friendly as cloud-based commercial platforms like Dropbox or Google Drive but without the massive compliance drawbacks. Any change to records are captured in the audit trail and the system provides end-to-end encryption and prevents unauthorized data modifications by ensuring role-based access.

COST
EFFICIENCY
COMPLIANCE
COLLABORATION
Shared network folders
  • Medium cost borne by each user
  • Reimbursement complexity
  • Complicated security, easy to overshare
  • No oversight.
  • limited audit
  • Non Compliant
  • Limited audit trail
  • Potentially insecure (sharing links)
  • Requires download/upload or proprietary software plugins, difficult to sync reliably.
  • Subscription Model
  • Medium cost per site (not per user)
  • Streamlined document control
  • Built for clinical trials
  • myClin Compliance Score
  • Fully compliant and pre-validated for
    ICH GCP E6(R2), EMA Annex 11 Sec 4,
    EU GDPR and FDA 21CFR11
  • Easy sharing, commenting, and versioning
  • Role based controls
  • Rich readership data

Intranet solutions vs. myClin

Unlike Microsoft Sharepoint, OneDrive or Google Workspace, myClin has none of the compliance drawbacks and is built to manage membership of users that are outside of the owners enterprise and desktop controls.  Any change to records are captured in the audit trail and the system provides end-to-end encryption and prevents unauthorized data modifications by ensuring role-based access without needing to create accounts for users in your private domain.

COST
EFFICIENCY
COMPLIANCE
COLLABORATION
Intranet solutions
  • Requires enterprise license/subscription
  • High cost of customization
  • Problematic outside of "home" organization
  • Learning curve for folder/document naming conventions and processes
  • Non Compliant
  • Limited audit trail
  • Potentially insecure (sharing links)
  • Unreliable across multiple organizations
  • Complex user management process
  • Subscription model
  • Medium cost per site (not per user)
  • Streamlined document control
  • Built for clinical trials
  • Deploy in 2 hours
  • myClin Compliance Score
  • Fully compliant and pre-validated for
    ICH GCP E6(R2), EMA Annex 11 Sec 4,
    EU GDPR and FDA 21CFR11
  • Easy sharing, commenting, and versioning
  • Role based controls
  • Rich readership data

Designed to fit your study size

myClin accommodates studies of all sizes. By leveraging a powerful and shared channel, you can scale your study communication between more team members, across different geographies and timezones.

Plug-and-play

myClin was designed from the site perspective and requires minimal user training, making it a fast and compliant solution for bringing new sites on board. The platform allows your study team to communicate, align, and control the dissemination of essential documents, and maintain best practices without layering on additional training and software expenses.

Data driven Oversight

myClin provides study teams with the best documented, data-driven clinical trial oversight. Study file management is automated, centralized, and secured. Audit trails and time-stamps let you keep track and verify which sites or team members are trained and up to speed. You can monitor progress through the Compliance dashboard.