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1. CTMS for Better Site
Management and Productivity

2. One of the biggest challenges
that clinical research sites face is
keeping a precise track record of
all the study operations while
working on the actual research.
Human error is inevitable when
trying to keep track of everything
at once.
In order to improve this practice, a
clinical trial management system
(CTMS) is now used. Learning
what a CTMS is, learning how to
implement and manage a CTMS,
and being aware of the benefits
that such a system offers is what
we'll discuss in this short
presentation.
Introduction

3. Planning in Advance
After this presentation, you'll be able to...
● Explain what a CTMS is;
● Know how to use a CTMS for:
- Negotiating better budgets and contracts;
- Punctual payments;
- Reviewing time spent per task;
- Working in compliance with FDA and Good Clinical Practice;
- Generating Reports;
● And learn many other advantages of using a CTMS;

4. Explaining a CTMS

5. A clinical trial management system (CTMS) is a specialized software
system for managing clinical trial operations that can be customized
depending on the needs of the specific site.
● A CTMS is a centralized system which means that it will organize and store all of your
site's operational data in one centralized location.
● A CTMS can be customized and adjusted to the needs of different entities. A customized
CTMS can be an asset for clinical research sites, cancer centers, academic medical
centers, site networks, CTSAs, SMOs, etc.

6. Financial and Budget
Management
Business Development
Patient Recruitment and
Retention
Subject Visits Management
Recruitment tactics,
budgets, and outcomes
Compliance with Regulations
With the help of a CTMS, you can take care of many different
components of a clinical trial, such as:

7. CTMS for Negotiating Better
Budgets and Contracts

8. Budgets that sponsors approve for your site conducting a study
are often not even enough to cover your basic costs. In order to
get better contract conditions and bigger budgets, sites will
have to negotiate these things with the sponsors. However,
negotiations need to be supported by actual numbers and facts
so that your sponsor is convinced of the actual costs you'll have
when conducting the study.
Calculating the actual costs and budget that you'll need for the
trial can be difficult without a proper system. For this reason,
implementing a CTMS can be the perfect solution for managing
your budget and finances.

9. - Calculation of overhead costs (expenses of doing business);
- Calculation of costs needed per patient/per visit;
- Calculation of costs per procedure/protocol;
- Consistency in expenses across procedures and protocols;
- Prove and justify all these costs to sponsors;
- Track all the payments and invoices from sponsors;
Clinical trial management systems can help you by
doing the following:

10. CTMS for Punctual Payments

11. When we're talking about a clinical site issuing
payments, we think of:
- payments towards patients as a reimbursement;
- payments towards vendors;
- payments to the investigators;

12. - A CTMS will establish a strong connection between visits and payments;
- Patients will be quickly reimbursed after every visit;
- Vendors will be paid per visit or procedure;
- Investigators will receive their payments promptly;
- You will be able to quickly see the payment status and the payments
history;
- You will maintain a positive cash flow throughout the study;

13. CTMS for Reviewing Time
Spent Per Task

14. Knowing how much time your staff spends on every task
is important for proper and accurate reimbursement. For
this reason, every clinical research site can use the help
of a CTMS.

15. Spot any inefficiencies on your site in
order to know what to improve
Learn how to increase productivity by
properly allocating time and effort
spent on tasks
Prove your budget planning to your
sponsor
Track the time spent on every
procedure and task
Almost every CTMS has built-in features for effort-tracking. With
the help of these features, you'll be able to:

16. CTMS for Compliance With FDA and
Good Clinical Practice

17. Conducting a study in compliance means working
according to FDA rules and regulations and in
accordance to Good Clinical Practice regulations.
This entails having well-documented tracking of
everything regarding the site, procedures, protocols,
staff, and patients. This documentation has to be
current and up-to-date, and properly tracked, organized,
and kept (stored).

18. - Documents that you'll need to keep track of:
certifications, IRB reviews, training and
education documents, informed consent forms,
subjects data, etc.
- Using a paper-based system is out-of-date;
- Using an electronic system prevents damage
and loss of documents and data that cannot be
retrieved, and has a more organized approach.

19. Using a CTMS can help you work in compliance in the following ways:
- Give you alerts before documents expire so that you're able to replace them
promptly;
- A well-organized database of documents so that you always know where your
documents are and have access to them by just one click;
- Store and manage all the certificates and credentials of staff and investigators;

20. CTMS for Generating Reports

21. Reports in clinical trials will let
you have an up-to-date insight of
a current situation.
Basically, every question that you
have for the trial could be easily
answered with the proper report.
Reports generated with a CTMS can
cover:
- Staff effort-tracking;
- Financial and budgeting reports;
- AEs and SAEs;
- Enrollment outcome reports;
- Recruitment tactics outcomes;
- Deviations;
- Tracking subjects and visits;
- Tracking payments;

22. CTMS and Other Advantages

23. Everyone involved with the site and the study can have
a great benefit from a CTMS including your staff,
sponsors, investigators, and patients. A CTMS will do
the boring paperwork and administration, thus giving
your staff more time and energy to focus on the
research-related tasks.
In the next few slides, you'll read in more details about
a few other extra benefits that you'll get by using a
CTMS.

24. 24
Know your ROI (return on
investment) on recruitment
methods such as marketing and
advertising your trial;
Follow the recruitment from
the beginning until the end;
Compare the outcome results
of recruitment tactics;
Follow your contacts history
including communication
efforts, calls, responses, and all
the other steps of
communication;
Pinpoint the recruitment areas
that need improving;
CTMS and Patient Recruitment Methods

25. Easily find every subject's
information and visiting
schedule;
Central storage of all data
regarding the trial: protocols,
subjects, visits, etc.;
Re-calculation of schedules
for an accurate tracking;
Have an overview of daily
schedules, tasks, and protocols;
Automatically generated
calendar assignments;
CTMS for Subject Visits Tracking and
Management

26. Provide you with a centralized storage where
you can keep sponsors and CROs information;
Increase your site's reputation and chances
to obtain studies by showcasing your
previous results and outcomes;
Performance charts, graphs and actual
numbers that will serve as a proof of your
quality work practice;
Keeping track of all communication and
interactions together with the necessary
documentation;
CTMS and Business Development

27. CTMS for a Consistent and Standardized
System
By having a system with standardized fields…
everyone from your staff at a site can enter data correctly;
you'll prevent mix-ups and errors which will positively affect compliance and
access to information;
you'll have a better workflow and consistency and much better results than
before;
you'll standardize your work processes and organize your site and data better;

28. ✓ A CTMS can help you negotiate a higher budget and a better contract
with sponsors by accurately calculating the costs you'll have;
✓ It will help you pay your obligations promptly by tracking payment
schedules of patients, vendors, and investigators;
✓ A CTMS will help you measure the time that's spent on every
separate task and protocol, so that you can see which areas need
improvement;
✓ Using a CTMS will help you work with compliance with FDA
regulations and according to Good Clinical Practice;
✓ A CTMS can quickly generate and export any reports you might need;
Checklist

29. ✓ It can help you track and assess your patient recruitment methods
and tactics so that you have an idea of what works and what doesn't;
✓ A CTMS will help you track and manage patient visits and
information;
✓ A CTMS will help increase your study pipeline by showing actual
numbers of your great works in the past, thus making your site look
more professional to sponsors and CROs;
✓ And finally, a CTMS will allow you to have a standardized system for
data entry that will improve your site's workflow and organization;
Checklist

30. Research sites are a 'high-stakes' business and they
require big budgets.
For this reason, it's important to conduct this business as
professionally as possible. A clinical trial management
system (CTMS) is the best way to do this!
Conclusion

31. THANK YOU FOR YOUR
ATTENTION!