Clinical research organizations (CRO) and research sites, hospitals, and health systems – all they do an underappreciated effort during the clinical studies. Consequently, they come up with new medications and devices that help us cure diseases. And that is why it is crucial to constantly supply these institutions with the most modern technology that can boost the process.
Medical trials involve a lot of data management, communication coordination, and quite some paperwork. A clinical trial takes on average 6 to 7 years to complete, however, the total time might vary depending on the main purpose and the duration of each phase. All the management tasks draw attention away from clinical research, but they are still vital for getting accurate results.
So how do we utilize all the benefits of modern technologies to foster big achievements in the medical world? Is there something that can make the process easier? Is it possible to keep everything about the trial process in one place?
A clinical trial management system (CTMS) is your answer. Read the article and find out all the advantages of using a CTMS, which features it has, and what are the main steps to take while creating a clinical trial management system software.
Discover CTMS benefits with Langate!
What is a Clinical Trial Management System (CTMS)?
The World Health Organization defines clinical trials as any research study that involves human participants and is aimed at analyzing the results of specific health-related interventions on health outcomes. A clinical trial is a very complex process that usually consists of 3 stages:
- Phase 1 involves from 20 to 100 healthy volunteers, lasts several months, and is aimed at finding the best dose with the fewest side effects.
- Phase 2 involves up to several hundred people with the disease, lasts from several months to two years, and is aimed at assessing the efficacy and side effects.
- Phase 3 involves from 300 to 3,000 volunteers with the disease, lasts from one to four years, and is aimed at comparing a new drug to the standard-of-care drug.
Not so long ago researchers have been utilizing simple spreadsheets and emails to store the information about the study. Such inefficient communication was making the whole process less organized and effective while negatively affecting the quality of research results.
To improve the clinical trial process institutions utilize various tools for efficient planning, managing, and data tracking. That is why the Clinical Trial Management System (CTMS) is a must for the clinical trial process.
Clinical Trial Management System (CTMS) is a software system used by biotech and pharmacy to manage clinical trials. Such systems support research on every step of the trial: planning, setting up, conducting, analyzing, and closing the trial up. Everything happens on one platform that helps to keep relevant information updated and unforgotten.
CTMS will help you to omit the questionable results. In fact, it will make the clinical trial process more about research than organizing everything. Thus, more exciting!
Benefits of Building a Clinical Trials Management SaaS Platform
The global Clinical Trial Management Systems (CTMS) market size is projected to reach USD 1693.1 million by 2026, from USD 950.5 million in 2020, at a CAGR of 10.1% during 2021-2026.
It is no surprise since, with this technology, companies will be able to do more trials in less time, without mistakes or billing problems. It can contribute to overall faster development of healthcare and more high-quality clinical trials.
So, let’s take a closer look at the benefits that CTMS has to offer to both researchers and stakeholders.
Efficient Data Management
Being too involved into the clinic studying process, researchers often disregard the data structuring, for instance, while peering for the documents placed in a no-name folder. Therefore, when it comes to submitting the results, they are all messy and barely comprehensive.
However, CTMS allows researchers to collect, keep, and access data in a secure and centralized location, so it’s easier to attach and find any documents, patient information, protocols, etc. Thus, you will save more time, investments, and efforts needed for completing and presenting the clinical trial results. Moreover, when you have the separate spaces for different trials, the data won’t be mixed up or shared with the wrong stakeholders.
Needless to say, that protocol compliance is a major procedure to be maintained in the healthcare industry. The fines for non-compliance in healthcare can be significant. For example, for missing the one-year deadline for reporting trial results to ClinicalTrials.gov penalties can go up to $12,103 a day. Also, the requirements for conducting clinical trials of medical products during the COVID-19 are so complex that it is impossible to keep track of everything manually.
CTMS is the solution on how to ensure the protocols compliance and provide regular updates on the clinical trial progress. With the process automating, it is easier to keep the research team, CROs, partners, and the federal organizations like FDA informed regularly, and contact them anytime if needed. Moreover, facilities can be sure that no piece of information is lost and the research results are accurate.
By using CTMS to facilitate the internal and external institutions’ collaboration, facilities can be sure that the research results are accurate and all the legal requirements are taken into the account.
During any clinical trial, information security is one of the crucial points that must be kept in mind so as not to give valuable data to third parties. Therefore, CTMS has the best safeguards as secure messaging solutions and secure cloud storage services to ensure the safety of data and full compliance with HIPAA requirements.
Transparent Financial Management
According to research based on US FDA statistics, the average cost of clinical trials greatly depends on the number of studies. Thus, approved with a single trial, two trials and 3-11 trials were around US$28, 45, and 91 million respectively. So transparent financial management is especially relevant for facilities to attract sponsors. CTMS allows you to easily integrate data about the process, completed tasks, and its costs so that every site is paid on time. Since every receipt and information about the revenue is kept in one place, it is easier to get an overview of the budget and clinical operations.
Moreover, transparent financial management is important for complying with the Sunshine Act that requires all manufacturers of drugs, medical devices, and medical supplies to track and report the financial relationships with physicians and teaching hospitals to Centers for Medicare and Medicaid Services (CMS). Having a financial management system within your CTSM is the best way to approach this legal aspect.
Minimized Mistake Possibility
Recent research based on the analysis of 45 clinical trial datasets had revealed that only 13.3% of datasets had zero mistakes, 7.8% of datasets had one mistake and 69% of datasets had more than two mistakes. In most cases, incorrect data in the research results is caused by manual data entry. The desire to solve the problem of data duplication is one of the reasons why organizations create a clinical trial matching software.
Preventing Multiple Trial Enrolment
Multiple trial enrollment is a common problem that results in security and data integrity issues. A situation when a trial participant is being involved in numerous trials at the same time increases the placebo rates and possibility of adverse events while negatively influencing the data quality.
Clinical Trial Management Software utilizes biometric technology including fingerprint authentication and facial recognition to locate the information about a person’s participation in other trials and prevent dual enrolments.
Features that Should Be Included in Your Clinical Trials Management Software
Although there are plenty of available solutions on the market, it’s better to make a custom clinical trial management system. Every organization has its own workflow, and only custom software can cover the business needs to the fullest extent. Such SaaS solutions have a lot of benefits that we have discussed before, and to make the most of it, clinical trial management system software must include the following features:
Researchers Performance Monitoring
It provides not only essential information about the name, age, and position of every registered researcher but their certificates, levels of expertise and interest, availability. It helps you to find skilled and available candidates for the next project.
Monitoring and Protocol Management
All the tasks, due dates, and responsible researchers are kept in one space, so it is easy to get an overview of the workflow. You can schedule clinical trial site visits and distribute documentation easily as well.
For getting full access to the research data and making constant modifications, researchers need a software that would work smoothly across all platforms. The ability to work with different devices without attaching to the PC nowadays is a must for launching a SaaS platform.
Secure Cloud Storage
While conducting clinical trials researchers need to organize and securely store massive amounts of data about the study itself and its participants. So clinical trial management systems should have cloud storage that is both compliant with legal regulations and easy for authorized parties to access.
Payment Management System
Track the tasks, put up receipts, and make payments in one system. Without switching from one system to another, it is easier to track all the financial operations that are to be done in time.
Main Steps to Build a Clinical Trial Management Software That Will Succeed
After reviewing the crucial features that must be integrated into a custom CTMS, let’s learn how to make a clinical trial data management software as quickly and efficiently as possible.
Define the Clinical Trial Targets
While building a secure SaaS platform for healthcare, it is important to define the goals of the research and preferences of crucial features that the software should include:
- researchers and patient information management
- workflow management
- resources management
- clinical decision support system
- multi-lingual requirements
Furthermore, when you make a clinical trial database software it is important to include all the compliance and safety aspects into the system as well.
In such a way, it is easier to decide all the features and wireframes, establish tasks and stages of the great project that building a CTMS is.
Create a Workflow System
At this stage, it is important to apply the basic functions defined by the targets to your platform. Mind the system interface, including cloud storage and multilingual services when you build a healthcare SaaS platform. Additionally, apply different portals for consumers and researchers so as to store the data in one system.
Develop an Efficient Design
UX is significant if you want to build a web based clinical trial software. If designed poorly, it is not worth the money spent on CTMS: it will be as struggling to use as spreadsheets and emails.
Set clear navigation requirements, develop grouping and hierarchy of elements since CTMS controls too many aspects and you do not want them to be confusing. Also, make it as intuitive as possible.
Find a Development Team
It is great if you have recommendations from your colleagues or friends. However, if you do not, check the portfolio of the company and contact ones who claimed to build a clinical trial management system with them.
Prices will change significantly, depending on the country and company. However, remember the rule that nothing too cheap is reliable and high-quality.
Choosing a vendor is a very responsible task since you do need skillful software developers to create a good product.
Test the SaaS Platform
It is crucial to check out the software performance, as it has to comply with the following requirements: availability, efficiency, maintainability, and stability. The system has to be easy-to-use as well as secure so as to strongly protect all the data stored in it. Additionally, the user authentication must be reliable and simple, thus improving the UX and making the clinical trial process much better and efficient.
Conduct the test runs of the software and collect the researchers’ feedback. This would help you check the system for bugs and fix them. Making sure that the research progress won’t be lost due to sudden technical issues could save you from significant financial losses.
One company in the healthcare niche has contacted Langate to create a clinical trial software platform that prevents dual enrollment in clinical trials and guarantees full data confidentiality.
We developed a technical solution based on the de-identified Unique Identification Codes that detects multiple enrollment attempts. Implementing this solution has helped the client to significantly reduce study-related costs and enhance the quality of trials while maintaining full patient confidentiality. Consequently, they have managed to become one of the largest research subject clinical trials database registries.
CTMS has numerous advantages that both researchers and sponsors benefit from: better data management, transparent financial management, better resources management, and the smaller possibility of human mistakes.
If you want to enjoy more efficient clinical trials and get all the essential features of CTMS and more, contact Langate. We know how to develop such complex systems from the scratch and are ready to share our experience with you.