CTMS for Better Site Management and Productivity

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

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;

Explaining a CTMS

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.

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:

CTMS for Negotiating Better Budgets and Contracts

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.

- 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:

CTMS for Punctual Payments

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;

- 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;

CTMS for Reviewing Time Spent Per Task

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.

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:

CTMS for Compliance With FDA and Good Clinical Practice

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).

- 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.

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;

CTMS for Generating Reports

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;

CTMS and Other Advantages

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.

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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

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

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

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;

✓ 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

✓ 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

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

THANK YOU FOR YOUR ATTENTION!