Flat Rate License Fees

What is a flat rate license fee?

A flat rate license fee is a fixed scheduled fee for use of a system for a trial, for example, $2,350 per month.

A flat rate license fee is not effected by:

1. the number of users

2. the number of sites

3. the number of system modules used.

How does a flat rate fee help to

control your budget?

With a fixed fee schedule, you will be able to forecast based on a number you know will not change

As your study progresses, you may find that you need to add more trial resources (Study Coordinators, CRAs, CTAs etc.), more sites, or additional functionality.

The flat rate license fee will allow you to grow your user base, add on additional sites, and add on additional functionality all without having to worry about adding these resources will affect your system license budget.

How does a flat rate fee help assist with 21 CFR Part 11 compliance?

As the need to add additional resources for your trial is realized, it might become attractive, in a user, site, and/or module based license structure, to ask the users to share their system usernames and passwords in order to save on system related cost.

The sharing of usernames and passwords is a major violation of 21 CFR Part 11 compliance. In a flat rate license fee structure, you will not feel the need to go down this non-compliant path because you can add as many resources as you need to without having to worry about your system license budget.

The trial will start with 10 sites, 50 users, using 5 modules (EDC, IWRS, Protocol Deviation Log, the Safety Database, and DSMB Profiles) and is expected to last 36 months.

• Company A uses a user/module based license structure.

The fee is $10/user/module/month, over 36 months the expected budget is $90,000

• Company B uses a user/site based license structure. The fee is $25/user and $100/site/month, over 36 months the expected budget is $81,000

• Company C uses a flat rate license structure. The fee is $2350/month, over 36 months the expected budget is $84,600

Let’s take a look at an example of how flat rate license structures compare to user, site, and/or module based license structures.

After 3 months you decide to add Clinical Trial Material Management within the system as well as to use the eTMF and Team Calendar, an additional 3 modules (8 total). You also add 2 more sites and 7 more users.

• After 8 months you realize your enrollment goals are not

being met and you need to add more sites in order to speed up enrollment to complete the study. Your management ask you to add an additional 5 sites, and that will be an additional 15 users.

• After 14 months enrollment has picked up but you finally get regulatory approval in a country your management would really love to include in the study so you add 4 more sites and 12 more users.

• After 24 months, enrollment is over but as a result of a safety concern, you need to bring on additional data management and clinical assistant resources to help prepare for an upcoming DSMB. You bring on 5 DM and 5 CTA users as well as request the systems vendor to add the full Patient Profiles module for use.

After 36 months the trial is over, let’s see how close you are to the original expected budget!

Timeline Company A $/Month

Company B $/Month

Company C $/Month

Study Start Up

$2500 $2250 $2350

3 Months In $4560 $2625 $2350

8 Months In $5760 $3500 $2350

14 Months In $6720 $4200 $2350

24 Months In $8460 $4450 $2350

36 Months In $233580/

260% increase!!

$136275/

168% increase!

$84,600/ on budget!!!

To learn more about our services or to request more information, contact us: partners@atomsedc.com or Joel Stephens at joel@dbintegrations.com