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Florence eTMF

Florence eTMF

Overview

What is Florence eTMF?

Florence eTMF is clinical trial document management and workflow platform, where users can create, edit, sign, gather and review trial master file documents. Sponsors can also manage all site workflows in the system when connected to the Florence electronic investigator…

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Pricing

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What is Florence eTMF?

Florence eTMF is clinical trial document management and workflow platform, where users can create, edit, sign, gather and review trial master file documents. Sponsors can also manage all site workflows in the system when connected to the Florence electronic investigator site file.

Entry-level set up fee?

  • No setup fee

Offerings

  • Free Trial
  • Free/Freemium Version
  • Premium Consulting/Integration Services

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Product Details

What is Florence eTMF?

Florence eTMF is clinical trial document management and workflow platform, where users can create, edit, sign, gather and review trial master file documents. Sponsors can also manage all site workflows in the system when connected to the Florence electronic investigator site file.

The solution presents workflows to get a study set-up and activated:
  • Control and standardize eTMF templates and naming conventions based on TMF structure and SOPs for a quick setup.
  • Customize granular access and permissions for the study team and external users (regulatory agencies, CROs, sponsors, sites, etc.).
  • Create placeholders, due dates and task assignments to keep studies progressing.
  • Create, distribute and complete customizable electronic logs.

The platform also presents multiple methods of creating and gathering TMF documents combined with advanced dashboards.
  • Visualize entire eTMF, including site files when integrated with SiteLinkâ„¢, with a single click to quickly identify missing or expired documents.
  • Upload documents directly into the eTMF by dragging and dropping or browsing computer files.
  • Sync documents directly into the eTMF with a simple email.
  • Leverage Part-11 compliant eSignatures to complete and finalize all document types within the system.

Within the platform, the user can keep track of the entire study and identify risk areas with advanced reports and dashboards.
  • Run reports around document health metrics, open action items, study attributes, and TMF completeness.
  • Track eTMF and study site milestones through custom dashboards.
  • Dig deeper with completeness and timeline metrics to identify bottlenecks.
  • Identify at-risk areas faster with real-time visibility into site documents.

For remote collaboration with various sites, users can deploy and connect to the electronic Investigator Site File (eISF) at every study site.
  • Distribute binders, documents and placeholders to your sites electronically.
  • Collect, route and query documents from your sites into secure areas of the eTMF.
  • Create document queries and communicate with sites through the monitor review module.
  • Activate remote site monitoring and remote source data verification with SiteLinkâ„¢.

Florence eTMF Technical Details

Operating SystemsUnspecified
Mobile ApplicationNo
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Reviews From Top Reviewers

Community Insights

TrustRadius Insights are summaries of user sentiment data from TrustRadius reviews and, when necessary, 3rd-party data sources. Have feedback on this content? Let us know!

Florence eTMF has been instrumental in solving various business problems faced by users in the clinical trial industry. With its efficient features and user-friendly interface, it significantly cuts study start time in half, streamlining the entire process. Users have reported a more efficient and streamlined workflow, allowing them to accelerate study timelines and meet project milestones.

One of the key business problems that Florence eTMF addresses is the need for consistent visibility into files. Through the software, users have experienced ongoing access to their documents, enabling them to stay on top of tasks and responsibilities. The shared platform with clinical sites has been particularly appreciated, creating a seamless collaboration experience among study teams.

Additionally, Florence eTMF has successfully facilitated the transition from paper TMF to electronic TMF for many users. The dedicated team behind the implementation and deployment process ensures that users receive adequate training and support during this transition. The phenomenal training modules provided have been described as instrumental in helping users improve their skills with the software.

Although some users have encountered roadblocks with permissions and accessibility when working with clinical sites, overall, the experience with Florence eTMF has been positive. By providing immediate access, easy searchability, and an organized feel even in an electronic format, this software has served as a reliable replacement for traditional paper binders commonly used in clinical trials.

Overall, Florence eTMF solves critical business challenges by increasing efficiency, providing ongoing visibility into files, aiding the transition from paper to electronic TMF, and creating a seamless collaboration experience among study teams.

Efficient Document Management: Reviewers have found the electronic document management feature of Florence eTMF to be highly beneficial. Many users appreciate how easily documents can be located, retrieved, and shared with study sites, streamlining the process of collecting and quality controlling documents.

Convenient Email Integration: The ability to email documents directly to the binder is considered a huge positive by reviewers. This feature is seen as convenient and time-saving. Additionally, granting user access and creating digital template logs are mentioned as beneficial features.

Easy-to-Use Interface: Users love the versatility and ease of use provided by Florence eTMF. They highlight its clean structure, flexibility, and useful functions. The program is described as user-friendly, logical, and easy to navigate. Many reviewers appreciate the ability to edit and upload documents, as well as collaborate as a team within the software.

Reporting Features: Some users have expressed that the reporting features in Florence eTMF are of little value, particularly when sites do not use consistent tags and labels.

Search Function: The search function in the software needs improvement as it is not folder-specific, making it difficult for users to locate specific documents.

Binder Structure: The complicated binder structure for studies has been a common concern among users, who find themselves spending time deciphering where documents are saved.

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