Clinical Trial Management SaaS Software Development Guide

Clinical trial management system (CTMS) software is used by life science and healthcare companies to track study participants, procedures, and data. Many pharmaceutical and biotech companies use a CTMS to improve the efficiency of their clinical operations.  

 

In order to stay competitive in the life science and healthcare industries, it is important for companies to have a CTMS that meets their specific needs. As a result, many CTMS providers offer customization services to ensure that the software fits the customer's requirements. 

Developing custom CTMS software can be a complex process, but it is worth the effort if it results in a system that meets the needs of the customer. That’s why it is especially important to find the right technology partner with deep expertise in this sphere. 

 

For example, at Onix, we’ve been building custom solutions for healthcare for more than 20 years so far. Thus, in this blog post, we will explore some of the considerations involved in building winning CTMS software.

 

The entire process requires lots of data management, paperwork, and communication, all of which distract from the clinical research itself. What do research and development do to automate these routine processes? 

 

A CTMS (clinical trials management system) may provide a solution, and in this article, we discuss the main benefits, features, and stages of such software development.

 

 

The Purposes and Configurations of Clinical Trial Management Software

What is CTMS used for? It helps researchers and Clinical Research Organizations (CROs) organize all the steps of the clinical trial process from creating a list of volunteers to analyzing the achieved results.  

 

Other facilities where clinical research is conducted, such as research hospitals, physician practices, academic medical centers, or cancer centers, also widely utilize CTMS.

 

Clinical trial management holds the possibility for automated patient recruitment. Usually, the companies look for people through traditional channels: TV, print media, and radio, so a massive amount of candidates may apply and researchers need to filter out the unfitting ones. With clinical research software, a CRO can easily detect applicants who meet their requirements and send them detailed information about current trials.

 

CTMS is also often used for facilitating siteless trials. Nurses arrange a meeting with participants at home. If bulky equipment is needed (X-Rays, MRIs, etc.), the clinical trial software helps plan the visits and allows researchers to take the material and conduct the remaining steps without physical contact. Siteless trials save the participants’ time, reduce travel-related costs, and allow working with homebound patients. 

 

With the help of CTMS, clinical trials can be monitored in real-time. It helps to analyze progress, detect potential problems, and set a financial goal.

 

When the number of patients and tests are small, organizations can make do with basic in-house systems handling their data. As data volumes and complexity grow, the need for more comprehensive software arises. The sponsors of clinical trials may provide such CTMS to the sites that participate in their trials, or the sites may use a software of their choice to support their day-to-day operations. Some systems require dedicated servers, but cloud-based CTMS are more popular. The latter are marketed as software as a service (SaaS). 

 

 

Let’s dive deeper into the main benefits of building such a solution.

 

The Benefits of Creating a Clinical Trials Management Platform

All parties at clinical trials - CROs, researchers, participants, and sponsors - may benefit from utilizing a CTMS. Here are some of its main advantages:

 

Efficient Data Management

Efficient data management is crucial for CROs, so they are willing to pay for quality software that would help ensure it.

 

When conducting a clinical trial in a traditional way, researchers focus on the trial as a whole. Being fully immersed in the process, they may fail to properly structure the wealth of information. For example, they may forget to name a material, causing inaccuracies in subsequent data. CTMS reduces the risk of missing any of the details. Every piece of information regarding a particular trial is located within one platform and can be quickly updated in real-time. 

 

Clinical research software collects and structures data in one place allowing to find any document within a minute. With CTMS in place, a CRO will not mix up the results of different trials as it records every case separately. By providing up-to-date details to study information, CTMS improves the transparency for researchers.

 

Protocols Compliance

The importance of data security and regulatory compliance in the healthcare sector can’t be overestimated. The financial penalties for violating legal requirements can be significant. For example, if a research organization doesn’t meet the one-year deadline for reporting trial results to ClinicalTrials.gov, penalties reach $12,103 per day.  

 

Clinical trial management software helps to ensure compliance with all the legal protocols and reminds researchers about important deadlines. The software also automatically updates the trial team, partners, and federal organization about the latest outcomes. CTMS promotes collaboration by bonding internal and external parties together and guarantees that the trial goes legally.

 

Research organizations will be likelier to invest in software that helps avoid massive fines than run the risk of paying them and losing their reputation.

 

Strong Security

It is essential to keep clinical trial information protected from third parties. CTMS provides different access levels to researchers and enforces multi-factor authentication, strong passwords, and other SaaS security measures.

 

 

SaaS management software for clinical trials goes further and offers secure messaging, secure cloud storage, virus protection, data encryption, and server monitoring - and their clients are prepared to pay for these advantages.

 

Transparent Financial Management

US FDA reports that the median cost of a clinical trial is $19 million; in every case, the amount mainly depends on the number of studies. They are usually funded by sponsors who request reports about the budget allocation. Using clinical trial administration software, research organizations can track every single receipt and pursue a transparent financial policy.

 

Furthermore, according to the Sunshine Act, the manufacturers of drugs, medical devices, and supplies should report on the financial side of relationships with physicians to Centers for Medicare and Medicaid Services. CTMS makes it easier to deliver the information in a legal way.

 

Minimized Risk of Mistakes

Another benefit of clinical research software is accuracy in storing the data. The statistics say that only 13.3% of analyzed trials were conducted with no error, while others made at least one mistake. Even one mistake may jeopardize the whole clinical trial. The functions of CTMS are fully reliable, so researchers will have more time to concentrate on the trial. 

 

Again, the cost of implementing a CTMS cannot be compared with a wasted research budget, fines, and the loss of future profits that errors may cause.

 

Preventing Multiple Trial Enrolment

A patient’s enrollment in multiple trials may negatively affect the results of the research. Clinical research administration software utilizes biometric technologies such as fingerprints or facial recognition to detect patients who are currently participating in another trial and prevent their enrolment. It excludes the possibility of money and time waste caused by professional clinical trial participants.

 

Improving Personnel Management 

CTMS often includes features of employee benefits software and simplifies the process of managing researchers, their payrolls, and benefits for meeting deadlines or other achievements.

 

Benefits administration software also streamlines the process of recruiting, managing, and paying the participants of a study.  

 

The pharmaceutical research and development process is long and may present many challenges. CTMS developers should also know about them and offer solutions that can give a competitive edge. 

 

Clinical Trial Challenges and Their Solutions

Specialists conducting clinical trials need to be connected with multiple systems and data resources. This is where the lack of uniformity appears. To prevent distraction on questionnaires, apps, forms, and other systems, they should choose a place where every result will be recorded.

 

Over the past decades, clinical trial data management has made a switch from paper documents to innovative forms, but the process of integration remains not automated. Specialists will appreciate a CTMS system that can bond all the sources together. 

 

Adopting Clinical Data Standards by CDISC 

CDISC (Clinical Data Interchange Standards Consortium) is a standards-making organization that allows data capture and exchange in clinical trials. They develop free and fully customizable standards which are suitable for every company. 

 

One of the most common CDISC standards is the Study Data Tabulation Model (SDTM) that defines how to organize the collected data into tables. SDTM datasets structure all the information collected during the clinical trial making it ready for regulatory submission.

 

Information in the SDTM format can be used for creating data models and making sense of the data collected. CDISC Analytical Data Model (CDISC ADaM) helps researchers structure and detect similar partners in the massive amount of collected information.

 

To make a long story short, CDISC has set numerous requirements on how clinical trial data should be captured, stored, used in analysis data model, and exchanged. It is almost impossible to ensure the correspondence to all of these requirements manually, but CTMS can easily do this automatically. 

 

Automating EHR-EDC Connectivity with the OneSource Model

Data from healthcare cases and data from clinical trials are not collected together. This is ineffective, as the combined results of both systems are useful for later analysis and use. But there is a way where Electronic Health Records (EHR) and Electronic Data Capture (EDC) can be connected.

 

FDA partnered with the University of California San Francisco and Stanford Centers of Excellence in Regulatory Science and Innovation to create OneSource - a mechanism that bonds EHRs and EDC.

 

The idea is that both EHRs and EDC data are located in one confirmed source according to all the clinical data standards. CTMS can facilitate this process enabling researchers to have access to complete information about the patients.

 

Modernizing Outdated CTMS Software

The first CTMS was developed more than 20 years ago, and a large number of current systems still rely on the practices that have been used there. Such legacy software no longer satisfies the needs of researchers, CROs, and sponsors. There is a need to either switch to a new solution or modernize current software. 

 

Specialists recommend following the second option because changing the entire software may slow down the work of the researchers due to a learning curve and would take some time to fully customize it. CTMS developers should be able to offer a solution that is better than the existing one, is easy to use, and is flexible enough to meet various needs of the clients. 

 

Both health tech companies and startups and institutions that want a custom clinical trial management software need to profoundly study all the needed features to implement.

 

 

Features that a Clinical Trial Management Software Should Include

The feature set of a CTMS and the features characteristics should be determined by the needs and goals of researchers that would be using it. However, the following features are essential to any clinical research software:

 

Researchers’ Profiles

Both participants and sponsors should be able to easily locate general information about researchers: name, address, degrees, licenses, specialties, and so on. This feature makes the relationship transparent and reliable.

 

Work Processes

The software should include a section where researchers can track and analyze all the workflows related to the participants’ reactions to various manipulations. 

 

Monitoring and Protocol Management

To avoid legal and financial consequences, a CRO needs to constantly monitor the protocols’ compliance and quickly address the detected violations. A CTMS should monitor the security of the data connected with participants and trial results. It should send notifications about potential security risks so they could be quickly addressed. 

 

Сlinical trials also imply risks to the participants’ health. By setting triggers that send alarms if a suspicious health condition is detected, researchers can detect and solve the problem in a timely manner.

 

Integrations with the Clinical Trial’s Website

Clinical trial software should have integration with the website so that all parties can gain easy access to the information about the clinical trial progress, current results, payments, schedule, etc.  

 

Secure Cloud Storage

As clinical research involves collecting a huge amount of documentation, data about the studies and the participants, it is important to upload the data into cloud storage that will be accessible for all authorized parties.

 

Mobile-Optimized System  

You may create a web application hosted in the cloud which guarantees trouble-free access from all around the world. However, a mobile version of CTMS will increase the convenience for researchers who have to travel frequently.

 

Payment Processing System

This functionality should facilitate tracking the tasks, forming receipts, and making payments in one place. Traditionally, these operations can be performed in different systems, but clinical research administration software can combine all these functions.

 

Connection to Wearables

The application of wearable technology can reinforce the research process. Integration with wearables allows CTMS users to track patients' health and get accurate data about patient-reported outcomes. This allows a decrease in the number of in-clinic patients and achieves cost reduction and improved subject retention.

 

Live chats

Consulting every participant via email or telephone may be cumbersome, and chats provide an alternative. Moreover, having all correspondence in one place helps to store the data in one place and ensure its security.

 

Electronic data collection

When it comes to clinical trial management software, electronic data collection is a must. There are a number of benefits to using electronic data collection over paper-based methods. First, it's more accurate. With paper-based data collection, there's always the risk of errors being made when transcribing data from one format to another. Second, it's more efficient. Electronic data collection allows for real-time data analysis, which can save time and money. Third, it's more secure. 

 

Paper-based data can be easily lost or stolen; electronic data, on the other hand, can be password-protected and encrypted. Finally, electronic data collection is simply more convenient. It eliminates the need to print and ship paper forms, and it makes it easy to share data with colleagues around the world. For all these reasons, clinical trial management software should include electronic data collection.

 

Recruitment management

In the clinical trial process, once a study is designed, the next step is to find participants who meet the eligibility criteria and are willing to take part in the trial. This stage of the process is known as recruitment, and it can be a challenge. 

 

Clinical trial management software (CTMS) can help with this task by providing a recruiting feature that helps to identify, screen, and track potential participants. This not only saves time and effort, but it also helps to ensure that studies are conducted with a high level of accuracy and quality. The recruiting feature in CTMS can also help to keep track of payments and compensation for participants, which is an important part of ensuring compliance with ethical standards.

 

Document management

When you're running a clinical trial, there are a lot of moving parts. You've got to keep track of patients, doctors, appointments, medications, and a million other details. And one of the most important things you need to keep track of is documents. Clinical trial management software should therefore include a document management feature. This would allow you to store all relevant documents in one place, where they would be easy to access and share with the people who need them. It would also help to ensure that all documents are up to date and accurate. 

 

 

Pay Attention to UI/UX Design of Clinical Trial SaaS Software

When designing сustom software for clinical trials, it's important to keep the user experience (UX) in mind. After all, if the software is difficult to use or doesn't meet the needs of the users, it's unlikely to be successful. Here are a few tips to keep in mind when designing UX for clinical trial software:

 

1. Make sure the software is easy to use and navigate. Clinical trials involve a lot of data, so the software needs to be intuitive and easy to use.

 

2. Design for different types of users. There are typically three types of users in a clinical trial: clinicians, patients, and sponsors. Each group has different needs, so the UX should be designed with all three groups in mind.

 

3. Pay attention to detail. Every little detail counts when it comes to UX design. From the colors and fonts used to the layout and functionality, everything should be carefully considered.

 

4. Use clear and concise labels on all buttons and menus.

 

5. Make sure the most important information is prominent and easy to find.

 

6. Use color coding to help users quickly identify different types of data.

 

7. Allow users to customize their interface so they can focus on the information that is most relevant to them.

 

8. Test, test, test. Be sure to test the software with users before launching it. This will help ensure that the UX is up to par and that there are no major issues.

 

Tech Stack for Clinical Trial Management SaaS

When it comes to developing a Clinical Trial Management SaaS platform, the tech side is important. It will determine how well the platform performs, how easy it is to use, and how reliable it is. There are a few different options you can choose from, and each has its own advantages and disadvantages. 

 

One popular option is the LAMP stack, which is made up of Linux, Apache, MySQL, and PHP. This stack is known for being stable and easy to work with, making it a good choice for businesses that want to get their platform up and running quickly. 

 

Another option is the MEAN stack, which consists of MongoDB, Express.js, AngularJS, and Node.js. This stack is more flexible than the LAMP stack and offers better performance, making it a good choice for businesses that need a more robust platform. Whichever stack you choose, make sure you select one that will meet your business's specific needs.

 

5 Core Steps to Build a Clinical Trial Management Software

We distinguish five main steps based on Onix teams’ experience in developing software for the healthcare industry.

 

1. Define the Goals

Before you start building SaaS management software for clinical trials, you need to point out the goals it should satisfy. Analyze the current issues with the administration of research and patient information, workflows, resources (including financial ones), etc. Consider a system of supporting clinical decisions and multilingual format.

 

Remember to take into account all applicable compliance and safety requirements. 

 

2. Create the System Workflow

SaaS platform developers need to implement multiple functions that will cover the defined goals. Look over the platform’s interface, secure cloud storage, its multilingual version, and add the portals where the researchers can overview the data. Try to focus on CDISC standards of how to present and structure the information. 

 

Read also: SaaS Application Security

 

3. Develop an Efficient Design

The design of CTMS should facilitate the input, structuring, and management of massive amounts of information. Establish clear navigation, group elements by hierarchy, and make the interface as intuitive as possible.

 

4. Build the Software

If you haven't developed SaaS products and clinical trial software before, experienced professionals can help you to save much time and headache. If you outsource the project or engage qualified off-shore software developers, you can also save money. The professionals’ hourly rates depend on the country and company, but you need to focus on quality first.

 

5. Test the SaaS Platform

Before you open your clinical trial management software to the whole world, you need to check its reliability, availability, stability, and efficiency. The data must be strongly protected and the platform should be easy to use.

 

Run the software and collect users' feedback. Fix the bugs and improve the system’s elements. Be sure that nothing will endanger the research and patients’ data.

 

How Much Does It Cost to Build a CTMS Software

The cost of a CTMS software can vary depending on the features and functionality required. Some basic CTMS software packages start at around $10,000, while more comprehensive packages can cost upwards of $100,000. 

 

In addition to the initial cost of the software, there are also ongoing costs associated with hosting, support, and maintenance. As a result, the total cost of ownership for a CTMS software can be significant. 

 

However, many companies feel that the benefits of using a CTMS software outweigh the costs. A good CTMS software can help to improve efficiency and productivity, reduce errors and costs associated with paper-based systems, and improve communication between different departments within an organization. When choosing a CTMS software, it is important to consider the needs of your organization and compare different options in order to find the best value for your money.

 

 

Conclusion

The implementation of clinical trial management software promises various advantages both for researchers and sponsors. With an effective CTMS in place, they can easily manage the data, ensure financial transparency, optimize the use of resources, and prevent human errors.

 

CTMS facilitates research reporting according to CDISC standards and proper budget calculations, and helps conduct trials in time and keep the information up to date. The software reduces the time of R&D development and addresses and solves clinical trial challenges related to lack of uniformity and integration of external and internal sides.

 

If you consider developing a CTMS that would successfully serve the needs of the research community and turn into a profitable business, please feel free to contact Onix. We have years of experience developing SaaS platforms and innovative solutions for healthcare. You can rely on our expertise at all stages of your product development, from market research and idea validation to testing and maintenance. 

 

FAQ

 

What is CTMS used for in clinical research?

In a nutshell, CTMS stands for clinical trial management system. It's a software that helps researchers keep track of all the important data and information related to their clinical trials. This includes things like recruiting participants, managing scheduling and appointments, tracking payments and expenses, and more. 

 

Essentially, it's a one-stop shop for everything clinical research. And while it might sound like a lot of work to keep track of all that data, CTMS actually makes things a lot easier for researchers. It streamlined the process and helps to ensure that everything is organized and accurate.

 

How long will it take to create a clinical trial management SaaS?

A clinical trial management SaaS can take anywhere from a few months to half a year to create, depending on the features and functionality you want to include. 

 

The first step is to choose a SaaS platform that meets your needs. There are a number of different options available, so it's important to do your research and select the one that's right for you. Once you've chosen a platform, you'll need to design and develop your SaaS application. 

 

This process can be broken down into a few key steps: 1) designing the user interface and user experience, 2) developing the back-end infrastructure, 3) testing and launching the application. Depending on the complexity of your SaaS application, each of these steps can take months. So, in total, it's realistic to expect that creating a clinical trial management SaaS will take at least 4 months.

 

Read Also: Components of SaaS platforms

 

How much does CTMS software support cost?

There are a variety of factors that can impact CTMS support costs, including the size and complexity of your organization, the number of users, and the level of support you require. That said, there are a few general things you can keep in mind when budgeting for CTMS support. 

 

For starters, CTMS support costs are typically subscription-based, meaning you'll pay a monthly or annual fee. Additionally, most CTMS vendors offer different levels of support, so you'll need to decide how much hand-holding you'll need. Once you have a general idea of what you're looking for, you can reach out to CTMS vendors for more specific pricing information.