Prelude EDC

Avantages

The Prelude team has been used extensively for pivotal animal health studies that have been submitted and approved by the regulatory agencies.

Inconvénients

I do not have negatives to share about the Prelude system.

Avantages

Our customer success manager [sensitive content hidden] and engineer [sensitive content hidden] were very helpful throughout the whole process of building something the EDC was not made for. They were constantly helping us troubleshoot and ensuring what we built worked for all stakeholders.

Inconvénients

I can't think of much, but calculations can seem a little complex sometimes. However, Prelude hosts monthly webinars to help you become more comfortable with the software.

Avantages

The Prelude EDC customer support staff are very helpful, knowledgeable, and friendly. As the Data Manager for clinical trial studies, I am able to collaborate with support staff to solve EDC-related problems and make improvements within the study EDCs. The EDC is very easy to use for both study clinical staff and study data staff.

Inconvénients

I dislike that sometimes EDC revisions have not been tested thoroughly before being passed to the study team for review.

Avantages

This software is very flexible. Any changes that may be required are a very simple fix. Most EDC companies take days and committees to go through updates.

Inconvénients

This software and the support behind it are all superb. I haven't mastered the ability to pull data in charts and other visuals for the C-Suite, but I imagine that is an easy process as well.

Avantages

The VISION EDC system is a user friendly interface that allows for one stop shopping. Everything you can possibly need to run a clinical trial is wrapped up in one package with customizability for the project at hand. The entire team from coordinators at the sites to managers and data analysts at the coordinating center have nothing but positive things to say about the system and its ease of use.

Inconvénients

I haven't come across an issue that doesn't exist in all other EDC systems such as the burden of administrating user accounts for large consortia which is a product of the end user more so than any one system.

Avantages

VISION EDC is the best EDC software that I have used. The functionality gives the ability to provide customized CRF pages with visit structures that mimic the Protocol exactly. The User Roles provide certain permissions in order to control who is responsible for which data. The Audit Trail records the date/time of every entry, change, query and tracks the role responsible. Plus, the Audit Trail and Database are are easily extracted to an XML file. Prelude's support team is outstanding.

Inconvénients

In all my many years of using VISION, I have not found anything to dislike.

Avantages

This software provides all the functionality we need to collect high quality veterinary clinical data. No two studies are the same, so the ability to quickly customize for each study is important. The Prelude team is very engaged, easy to work with and very responsive.

Inconvénients

No issues have been identified. Ability to use a cell phone app for EDC would be useful for some studies.

Avantages

VISION is very easy to use, it is very intuitive. The custom programming and logic are definitely a plus. I have used other EDC's and VISION's layout and functionality with regards to entering queries and query resolution, edit checks, document management, etc. are definitely superior to others.

Inconvénients

I am pretty satisfied with VISION as an EDC.

Avantages

Our study investigators and their staff love the interface. Our internal staff likes the design-build option and how responsive our Prelude project manager is to our needs.

Inconvénients

For some individuals there is too much feedback -- too many "bells and whistles".

Avantages

I like a lot of components of this product, but here are a few I have used and loved:
1. It is a one-stop shop product for clinical trials management.
2. Ability to customize eCRFs to study specifications
3. Ease of randomizing online
4. Real-time access to data for different users
5. Ability to monitor data and document audit trails
6. Uploading and maintain study document
7. 21 CFR 11 and Annex 11 for FDA studies
and many more

Inconvénients

Some suggested improvements to this product are:

1. Ability to download field specifications in an excel format
2. Ability to customize eCRFs to look exactly like the paper eCRFs

Avantages

The product is very easy to use. The software is user friendly providing real time data to the clinical study.

Inconvénients

I do not have any cons for this product.

Avantages

The Prelude Dynamics EDC system is very user-friendly, versatile, and quite intuitive from both the Sponsor/CRO’s AND the Clinical Site’s perspective. On top of that, the team at Prelude is forward-thinking and very supportive, providing great demos and training, thinking creatively about practical solutions for small and larger studies alike, and answering all of our questions very promptly and clearly.

Inconvénients

Nothing specific comes to mind at this time.