Florence has incredibly user-friendly software.

I would like slightly more control on timeline in the implementation phase.

Florence has enables us to go from paper TMF, to electronic TMF- which has been fantastic. We have learned a lot about electronic systems.

It has been easy to use Florence, especially once the binders are set up and the roles are established. It has been great for getting signatures from sites, and easily maintaining our TMF and site eISFs. It is so nice to have all the documents in a softare that is easy to navigate, and is constantly improving/ adding new features to make it user friendly.

The set up does take time, but there is a learning curve for everything. Especially systems as customizeable as Florence. The delegation of authority log feature has not worked as smoothly as I anticipated, given how many changes to study staff and site PIs that there are.

The email documents to the binder feature is a huge positive. Granting user access it also simple, and the ability to create digital template logs is beneficial. Also, the ability to change the title of a document if there is an error is a huge plus. I've worked in other eTMFs and to change a document name you have to make it "obsolete" and go through tons of other processes to correct it.

There is no search function. You cannot search for a specific document if you do not know which folder it is stored in. The binder structure for my studies is complicated, so I sometimes spend 10 minutes trying to decipher where a colleague or site might have saved a specific document. Also, when moving a document, you need to select all the folders to put it in which can be a bit time consuming.

Easy to use, signing and redacting features are wonderful and easy to use. Rarely any questions from sites.

We use Florence to create a Delegation of Authorities (DOA) Log and it is so difficult to use. You cannot see all site stafrf's responsibilities (Column with A-Z) activities that gives you ellipses after certain amount of letters and our monitors and team constantly need to download the DOA Log to view staff responsibilities then sort through all site staff versions to come to the most recent one. Would be great for you to make a visually easy to see DOA. Would save our team so much time.

paper TMF is a difficult endeavor - this cuts study start in half, and allows for consistent and ongoing visibility into the files so you can keep on top of things.

The fact that documents are electronic, easily located and retrievableeasy to share with study sites, easy to collect documents and to QC

the reporting features are only worthwhile if everyone including your ISF sites use tags and labels staff training and implementation at the sponsor has been uneven so it is of little value.the search function could use some real updating. lets make it folder specific!

Central document management makes it easy for stakeholders to access and file regulatory documents.

The logs are pretty limiting at present and seem to be geared toward tracking information that will not change throughout the trial. It is not conducive for use as a Delegation of Authority log, for example. The Florence team is reportedly working on implementing some of the feedback provided and we look forward to those future changes.

The Florence team helped with software implementation and deployment, and ensured that the team had adequate training.

I love the versatility, and easy of use.

I don't really have anything I don't like about the software.

Overall experience is great.

Ease of uploading and downloading documents filed. Audit trail is great.

Don't like that some documents don't upload and can view within the software and then have to download them separately.

Very pleased with the system and the support.

It is easy to move around in this program.

I would like for it to stay up longer and not time out.

I am essentially still learning how to work Florence but learning every time I use it. The training modules are phenomenal. I am just starting with working with a clinical site which where we have run into some roadblocks with permissions and accessibility.

The features I most appreciate in this SW is that fact that we have a centralized location for study files which is critical for our company. The training modules are stellar!

What I am having challenges currently is compliance and the allowed roles and responsibilities provided to a clinical site to 'manage' their own ISF. We are having to conduct our own Validation as this has been identified as a gap by our Compliance team.

Positive

I like the part 11 compliant signature feature the most.

I have nothing that I do not like about this software

Very satisfied overall.

Signature requests are very easy to assign and follow-up on.

Moving documents could be easier. Having to drill down through every folder is cumbersome.

Overall, Florence onboarding and customer service is amazing. They go above and beyond and are always supportive. Although pricing is more than average and there is some downsides overall the experience is great.

Florence has the ability to implement a regulatory compliant trial management file system easily for both you and all your clinical sites. Implementing changes within your file structure is easy. Uploading documents and adding users are easy to complete with simple toggles of buttons and drag and drops.

Florence still has some challenges in terms of bulk file uploading for example when a new site is onboarded and was previously on paper or transferred. Also, there is no interface to upload images or Dicoms. This is part of our TMF but we have no ability to add these to Florence. Also a CTMS would be great.

Florence is user friendly and logical. I like that it is easy to edit and upload documents and work as a team.

I don't like that there isn't always an easy way to access the website if you don't have the direct link bookmarked on the computer.

The systems flexibility to follow our company processes.

A few uploading issues, the system timed out and ended up loading multiple documents.

The ease of use and practicality of importing and exporting documents. Being able to easily locate documents within folders.

Folder structure is not consistent within each study which makes it difficult to locate documents if in another folder.

Good!

Clean structure, flexibility and useful of functions.

eLog can only populate one table. So, could not use for training record where trainer and trainee are two different tables.

It is great to have a shared platform with the site.

I like that I have access to the site's reg binder and don't need to bother them about essential documents. I like that they can send me notifications

I wished I could set up an alert for myself that emails me whenever a document is uploaded or changed.