10 Critical Factors Influencing Clinical Trial Management Software Cost

Key Takeaways:

  1. Aspects influencing initiation fees are customization, the complexity of the CTMS solution, and the level of support offered by the vendor.
  2. The cost of CTMS deployment for on-premise servers ranges between $2500 to $20,000. Whereas, cloud server cost ranges between $400 to $4500.
  3. Facets that incur compliance expenses for the clinical trial management software are data security measures, audit tools, and regulatory consultation calls.
  4. A contractual term is bound to affect CTMS expenses. Long-term commitment is likely to offer incentives or cost savings compared to short-term agreements.
  5. The initial startup cost of an EDC for clinical trials ranges between $5000 to $12,000. This also includes a monthly subscription and hosting price of $1000 to $5000.

Clinical trial management software (CTMS) is leaving a substantial mark in the research sector. Additionally, a number of healthcare organization are opting for CTMS solutions to enhance care services. For instance, OneOncology, a cancer center network announced the deployment of clinical trial management software across 11 of its oncology units. The center’s goal is to tackle the issue of minimum participation of adult cancer patients for clinical trials.

In addition, CTMS is disrupting the current healthcare landscape through AI and machine learning integrations. Algorithms play a crucial role in analyzing surplus research data and produce faster results. CTMS can indeed be a gamechanger for clinical trials. So, in order to get one for yourself, the first thing to know is its cost.

What is clinical trial management software cost?

On average, the cost of clinical trial management software (CTMS) ranges between $25 to $400 per user per month.

Now, various factors influence the cost of clinical trial management software – from customization and core features to training and integrations. Understanding these aspects is essential for researchers, healthcare organizations, and software development companies, seeking to invest in CTMS solutions. So that they can draw out their ideal budget estimate.

We will be navigating through these aspects in the article. So, you can seek out the best way to get a CTMS solution that fits your organization’s needs and demands. Let’s get started!

Critical Aspects Impacting Clinical Trial Management Software Cost

These elements play a critical role in influencing the clinical trial management software cost. Let’s dive right in:

1. Initiation or Setup Fees

Initiation or setup fees for CTMS are one-time costs incurred at the beginning of implementation. The initiation fees are influenced by aspects such as the scope of customization, the complexity of the CTMS solution, and the level of support offered by the vendor. While they represent upfront costs, these charges assure an efficient and tailored CTMS system that lays the groundwork for successful clinical trial management.

Another element that is most talked about during the setup phase is the mode of deployment – on-premise or SaaS/cloud. The cost of deployment for on-premise servers ranges between $2500 to $20,000. Whereas, the cost of cloud server ranges between $400 to $4500.

Now, make sure that the vendor clearly states what they’re offering during the initial deployment phase. Also, ask them, “what does the cost cover?” Out of the two, on-premise or dedicated servers are expensive because a hardware system is in place and a team is required to manage the server on-site. Cloud, however, requires a strong network connection, and the job is done.

2. Support and Training

In this case, ask the CTMS development company whether they offer training and support for the staff. If the answer is yes, then check whether the training and support costs are included in the subscription package or paid separately.

For a rough estimate, here’s what to consider for calculations:

  1. Staff or User Training: Cost depends on the type of training given to the staff. It also depends on the type of training required (depending on the level of knowledge base and learning ability). Training cost also depends on the number of users or staff members, and whether the training is conducted on-site or remotely.
  2. Technical Support: Cost is based on the type of support offered – troubleshooting, software updates, cybersecurity, etc. Also, expenses for technical support may be based on usage or subscription fees.
  3. Training Material: The CTMS development company may offer training guides such as user manuals, documents, and video tutorials, which may incur additional costs.

3. Compliance Expenses

Adhering to compliance is one of the necessities while developing any software related to the healthcare industry. Implementation of HIPAA compliance during the development stage ensures the privacy and security of the CTMS solution. Some of the aspects that may incur compliance expenses are:

  1. Incorporation of Data Security Measures: Consider the cost of incorporating data security measures such as data encryption, data backup and storage process, access controls, etc.
  2. Auditing tools: These tools facilitate internal audits, track compliance activities, and prepare for regulatory inspections. Consider the price based on the type of tools used. Some of the commonly used audit tools are AuditBoard, Onspring, and SAP Audit Management to name a few.
  3. Regulatory Consultations: Companies may charge hourly or include a free consultation call as a part of the subscription.

4. Commitment to a Contractual Term

How long will a healthcare organization commit to a CTMS development company’s terms and conditions? A contractual term is bound to affect expenses. Long-term commitments are likely to offer incentives or cost savings compared to short-term agreements. These may include waived setup fees, reduced subscription rates, or additional features at no extra cost.

Contracts can be based on a subscription pricing model, which is usually billed monthly, quarterly, or annually. This may include technical support, software updates, and other services. Contractual terms are negotiable, hence there are chances to seek price discounts, incorporate additional features, and adjust payment schedules.

5. System Integrations

Another aspect that influences the clinical trial management cost is integration with other systems. In a clinical setting, workflow efficiency can reach its zenith with seamless data transfers between multiple systems. Hence, this is a crucial element that must be included in the CTMS solution.

Consider integration costs for API and interoperability standards. If there are any custom integrations involved then that would be an additional expense.

6. Customization

Customization influences a majority of the clinical trial management cost because every researcher, provider, or organization would want a solution that meets their requirements. Development companies look to novel CTMS innovations for better custom features and functionalities. So, what elements to consider while calculating customization costs? Here they are:

  1. Complexity: So, a complex CTMS solution gives birth to extensive development work, which eventually incurs higher costs. Complex customization encompasses integrations, specialty-specific features, regulatory needs, and specialized functionalities.
  2. Development Company Support: Some of the companies offer customization services as part of their standard offerings, while others may charge additional fees for custom CTMS development. The cost of customization is influenced by expertise and level of support.
  3. Maintenance and Updates: Custom features and functionalities may require ongoing updates, maintenance, and support to remain functional and compatible with future software releases. Organizations can consider long-term maintenance costs as part of the overall customization investment.

7. Maintenance

If software is the engine then maintenance is the oil that needs to be changed once in a while. The cost of maintenance for clinical trial management software may or may not be included in the subscription fees. But, if included, then the software maintenance team releases updates when required.

Furthermore, if any major bugs or errors are found in the software then the development company may charge extra to eliminate the errors. Apart from this, maintenance costs may consist of security audits, compliance, and enhancements with industry standards and regulations.

Clinical trial management software maintenance cost also includes performance monitoring tools and infrastructure upgrades to maintain minimal expenses.

8. Pay-Per-User

Pay-per-user is a popular pricing model because it saves cost for organizations, and allows them to pay only for those users who will use the software. This makes it easier for healthcare organizations and clinical researchers to budget and forecast expenses related to CTMS usage.

Furthermore, this model is beneficial for organizations of varying sizes, from small research teams to large pharmaceutical companies and healthcare facilities. This is so because it offers flexibility to scale up or down based on user needs.

9. Cost of Essential Features

Make sure to ask the healthcare software development company whether they’re charging per feature. Is there a premium package for unlocking additional features? And what would be the cost of customizing features?

Once these questions are clear in the head, go back to the budget estimate and then make a call to whether to acquire the CTMS solution or not.

10. EDC Implementation Cost

EDC (Electronic Data Collection) is a system that is used to gather, clean, and scrutinize data generated in a clinical trial. This is an effective tool to manage the data of clinical research. Since it is an effective tool then what’s the cost of it? The prices depend highly on EDC capabilities, type of clinical study, and integrations.

Electronic data collection system can be differentiated into three price categories:

  1. High-end: $3500 to $5000 per month
  2. Mid-sized: $1500 to $3000 per month
  3. Small-end: $500 to $1000 per month

Apart from this, the initial startup cost of an EDC ranges between $5000 to $12,000, which is followed by a monthly subscription and hosting price of $1000 to $5000.

Summing Up

This article highlighted ten critical aspects that influence clinical trial management software cost. Out of the lot, customization had the strongest hold over the pricing because a lot of elements such as CTMS complexity, features and functionalities, and maintenance depend on the way software is built.

Further, overlooking the EDC aspect can pose certain challenges in data collection and analysis, hence it is paramount to set a budget for EDC implementation. Other than this, other facets such as setup fees, pay-per-user, training, and integrations, contribute significantly to the seamless functioning and usage of the software, hence need to be included during cost estimation.

As mentioned in the article, the cost of clinical trial management software (CTMS) ranges between $25 to $400 per user per month. But, to get an accurate estimate it is best to connect with a healthcare software development company and get a quote.

Arkenea can help you in this area and also aid with the CTMS development. Over 13 years of experience in the healthcare software development field has made us experts in it, and we understand your requirements and industry standards. To know more about CTMS development, hop on to a consultation call with us today.