Clinical Trial Backgrounds, News

12 April 2021

By Manuel Neukum, Chief Operating Officer

How to Select CTMS that will Positively Impact the Quality of your Study

The global usage of the clinical trial management system (CTMS) is increasing thanks to its outcome’s significance and efficiency. It lessens the cost of the amount invested In managing clinical trials. Reports indicate that the CTMS market’s valuation will grow from $570 million in 2019 to a projected rate of $1.4 billion by 2026.

Major factors that are steering the unprecedented rise of CTMS systems are the increasing adoption of CTMS in clinical trials and the rise of research and development (R&D) expenses of contract research organizations (CRO) and clinical study sponsors. The fast spread of COVID-19 is also seen as another primary driver in need of CTMS platforms with Market Research Future, claiming a 5.7% compound annual growth rate in the clinical trial market from 2019 to 2023.

With the use of CTMS healthcare systems, professionals can access centralized data easily, thereby reducing the number of delayed trials. It can also handle site recruitment and identification while simultaneously providing control and tracking over subjects’ database and subject enrolment. Outlined in this article are five steps you should take to find a CTMS solution that will bring wonders to the quality of your study

Prioritize Study Needs

An essential step to choosing the right CTMS is to consider and prioritize your study needs. Prioritizing allows you to find a solution that increases the quality of the study and eliminates doubts for researchers when faced with challenging decisions. While many providers claim to have all features and functionalities to do CTMS clinical trials, most do not have end-to-end plugins to successfully track and manage such processes.

Researchers coordinating with site centers for clinical trials can use CTMS platforms with reliable patient recruitment features. CRO and research sponsors should opt for a comprehensive end-to-end solution with built-in integrated payment functionality. Either way, the right CTMS can enable researchers to enter data intuitively and consistently. This means the CTMS solution should be easy-to-use, well-organized, and properly designed to reduce the clicks to finish a task.

It should also have easily generated and template-driven reporting plugins that can take the raw data, evaluate it, and present it in a way that administrators and researchers can benefit from. The CTMS benefits of using template-driven solutions are vital in efficiently managing the study-specific variations and quickly creating clinical projects. 

Select CTMS with Multiple Integrations

Integrated CTMS systems offer the best bang for your buck because they ensure research protocols operate efficiently. The importance and benefits of a clinical trial management software can only be realized through integrations because it guarantees easy transitions between site operation and data gathering. An existing integration with EDC is beneficial.

Find CTMS platforms that can integrate with the Clinical Research Process Content (CRPC) billing grid to easily facilitate the transmission of complex study billing definitions to an electronic medical record (EMR) platform. This integration empowers all team members involved in the billing and research processes to leverage identical billing designations to ensure compliance and reduce the need for duplicative processes in your EMR and CTMS systems. 

Billing and other financial system integrations available with most CTMS to make invoicing easier although some do not have general ledger system integrations. General ledger system integrations automate the process of sending research activity-related invoices to the public ledger and reconciling those payments within the CTMS. It also allows your financial team to view the status of your protocol and act upon that data quickly and efficiently. 

Ensure System Compliance and Security

System compliance and security is a critical aspect of CTMS solutions because it builds trust and forms a part of the system’s duties concerning the niche it belongs to. CTMS solutions are designed to adhere to regulations but ensuring compliance is contingent on the institution’s IT infrastructure, staff practices, and standard operating procedures. 

Organizations engaged in clinical research have many complex regulations to follow to ensure compliance with one of the particularly challenging areas of principles being information security and privacy. Ensure that the CTMS platform can configure both individual and group permissions and have a data backup and recovery plan for hosted systems. This way, you can find out the implications of privacy and information security in research and anticipate the concerns that can arise in each phase of the project. 

Having an audit trail also helps because it can provide support documentation and history that is used to authenticate operational or security actions and reduce risks. Audit trails can also identify areas of non-compliance by providing data for audit investigations. Health Insurance Portability and Accountability Act (HIPAA) and Code of Federal Regulations (CFR) Part 11 compliance on system security are also vital in ensuring the CTMS platform can increase trial status and financial transparency.

Scalability Matters

As an organization performing clinical trials, developing to increase revenues is always a possibility. This growth may be through the addition of several trial locations globally and domestically or the inclusion of trials at existing sites. 

Choosing a scalable CTMS that can fit various types of growth allows you to easily hop on trends and influx of demand while simultaneously lowering maintenance costs and ensuring better user agility. Scalability also means secure and more data storage. Rather than handling an increasing collection of hard drives, you can use a SaaS Solution. This ensures that it can fit your availability needs without experiencing the capital expense that comes with extending a physical infrastructure.

Many SaaS companies host their products in the cloud, and this requires partnering with a third-party cloud provider to store and host CTMS solutions for each client. 

Understand the Level of Support from the Vendor

Adopting a CTMS platform is a significant change for the organization. Even with proper training, questions and requests will arise from any researchers in some phases of the study. Choose a vendor with a first class Customer Success Team to ensure that you are not underutilizing the software or using it inefficiently. 

An industry standard CTMS vendor should provide comprehensive training and tutorials so that research organizations can improve themselves through the use of this innovative software. Training intensity will depend on the tech skill level of your researchers and the intuitiveness and user-friendliness of the solution. The frequency of training may increase due to the high attrition rate of users.  Your CTMS vendor must also ask for user feedback and implement the upgraded versions as per your evolving needs. Set up a robust communication channel and feedback mechanism for users to automatically provide their comments and have an opportunity to influence the roadmap. Partnering with a CTMS company that listens to your liking and inclinations will take the burden of training and retraining to increase the adoption rates.

Choosing the Right CTMS

There are so many layers and processes that are required to conduct a successful clinical trial. This includes relying on efficient processes and procedures that span multiple departments, strict quality controls, and tight adherence to regulations. The right CTMS allows researchers and staff to handle data collection, regulatory files, and financial management tools electronically.

Marvin eClinical Solution is an electronic clinical trial management vendor that empowers CROs, medical device corporations, and biopharmaceuticals to handle clinical trial data and drugs. It provides integrated modules such as WHODrug Coding, SDTM tabulation, data collection, study build, and drug management, which work conjointly to ensure seamless data flow and improved data quality. Contact us for a free demo: info@xclinical.com 

Image Credit: thisisengineering-raeng-8hgmG03spF4-unsplash

Hello, I'm Manuel Neukum, Chief Operating Officer

Manuel Neukum joined XClinical in 2011. He has a solid background in Computer Science as well as in Business Administration and Leadership. Together with Franciscus Pijpers he dedicates his time to fulfill the XClinical vision.

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