Are you overwhelmed with the heavy responsibility of evaluating a novel clinical trial management system (CTMS) for your organization, but have little experience with technology jargon? Are you unsatisfied with your current implementation of CTMS?? Well folks, if the answer is YES, stay tuned as we attempt to provide you critical insights that will help you practice due diligence while evaluating a CTMS vendor. The best part is that you need not be an IT nerd to do so!

Today every field, including the healthcare research industry is benefited by high-speed computers and information technologies. Undoubtedly, automation in managing the operational workflow of clinical studies through CTMS has changed the landscape for how CROs and life sciences organizations manage their phase trials today. The value that a comprehensive & properly chosen CTMS brings is absolute. Hence, comes as no surprise why there is so much anxiety that surrounds implementing or changing a CTMS.

What’s your need?

Each clinical trial management system comes with some unique features. Every vendor out there will make ambiguous claims of providing these to perfection and then many more. It is human tendency to compare features between solutions and kind of zero down to a few which provide maximum functionality. Remember the last time you bought that smartphone with those attractive features?

Probably you are out there to buy a CTMS since currently what you have is not working as per your requirement or is obsolete. A need assessment is the first step that you should introspect even before you step out to shop. 

• What capabilities (CTMS features) are you looking for and which best support your organizational goals? 
• Which features of the clinical trial management system are a must-have and non-negotiable? 
• What are your business dynamics and how often you may need to scale the functionality of the deployed CTMS software? 
• What are your current versus anticipated future needs? 
• Are you using other eClinical systems to manage your clinical operations data, which you anticipate integrating with the CTMS?
• Where do you plan to host your software?
• Are you looking for vigorous customization or would you be using the vendor-supplied solution?
• What are your data privacy and IT security requirements?
• What kind of actionable data insights do you need to achieve your goals?
• Who is your target user audience? What are your change management requirements? 

Identifying these tangible and intangible factors will help you in evaluating and choosing the software vendor that fulfills your exact needs. It helps you choose a CTMS solution that is in alignment with your objectives. 

Remember – Not all needs are absolute! 

CTMS Feature Analysis

If you are buying a ‘one size fits all’ COTS clinical trial management system, then you end up paying for all the product features. You may hardly use 40% of the available features in your deployment and during the entire life cycle of the product. 

Herein we have mentioned the list of core operational features which most modern CTMS platforms provide –

• Protocol set-up and management
• Subject visit calendar and tracking
• Site performance management and reporting
• Monitoring visit and report management
• Finance management and site pay-outs
• Regulatory document management
• Compliance management
• Dashboard monitoring of KPIs
• Report generation

The additional features that a CTMS may have are

• Site Feasibility Management
• Site Selection and Start-Up
• Budget Forecasting
• Workforce & work allocation management
• Risk-based monitoring using Data Analytics & AI
• Predictive modeling for risk identification

When you start to evaluate product features, you must identify and classify them into three categories

• Must-have Features 
• Nice to have Features 
• Features you can live without

Identify your top operational challenges by requesting inputs and feedback from your end-users. Analyze their point of view and check for CTMS features that best provide solutions to their pain points. The trick is to have a CTMS that is purpose-built and will adapt to your objectives and not the other way around. This way you will be paying only for features that apply to your organization. 

CTMS Scalability 

Nobody understands the dynamics and challenges of your clinical trial operations better than you. With revisions to protocol and protocol referenced documents, adaptive designs of trial, and regulatory updates, a need may arise to upscale the baselined solution. These unplanned changes may occur after you have finalized your user specifications and signed the work contract. Also, they may occur after the project goes live. 

Choose a CTMS vendor who supports these enhancements in the long run without difficulty and with transparency in costs.

CTMS Integration Capability

Is the CTMS built using open standards and can it easily integrate with other applications, is an important question you should ask your vendor. The CTMS must have the capability to integrate with other eClinical solutions developed by third-party providers.

CTMS User Adoption

A CTMS software that is difficult to navigate or has archaic processes will have a very low adoption rate. Three factors play an important role in facilitating seamless end-user adoption as follows –

• Comprehensive training plan – Initial & Continuous 
  • Training intensity will depend on whether your end users are tech-savvy or need intense hand-holding to adopt the new technology platform. It will also depend on how intuitive and user-friendly the solution is. Training modules in the range of 3-4 hours are a good indicator of an intuitive and user-friendly solution. 
  • Training frequency will increase if you anticipate a high attrition rate of your end-users.
  • Your CTMS vendor should be able to share the training & retraining burden, as per your predefined requirement. 
• Intuitive User Interface & User Experience
  • The adoption rate is high if the user experience is enhanced by the look and feel (aesthetics) of the design, and its intuitiveness to complete the various tasks on the interface. 
• Robust feedback mechanism
  • Your CTMS vendor must solicit user feedback and implement changes in the upgraded versions as per your evolving needs. For doing so, a robust feedback mechanism and communication channel should be in place. End users should be able to automatically provide feedback and have an opportunity to influence the software roadmap.

CTMS Data Warehouse

Where is your valuable DATA stored?? Confirm if your vendor uses a scalable backend database to store your precious data. Check if the warehouse is designed for query and analysis also, rather than for transaction processing only. Data stored in the database is not only easily and readily available but is also easily mineable and usable in infinite ways possible. Check with the CTMS vendor if data consolidation, analysis, and reporting at different aggregate levels is possible even if not specified before.

CTMS Deployment Model

Selecting the right CTMS solution is no longer just a matter of selecting a vendor based on software features. The delivery model that they support is equally important. There are various deployment models available and not all vendors support all models.

Today we have several options for choosing the delivery model. Individual businesses have valid needs for choosing one over another – such as level of security, stringent confidentiality requirements or decentralized remote users. The available models are –

• Hosted
• On-site/ On-premise system
• Public Cloud                            
• Private Cloud                                                          
• Hybrid

You may want to consider the following factors when deciding on the right delivery model for your organization:

• The skills and size of your IT team
• The strength, scalability, and reliability of your IT infrastructure
• Your budget, as the cost varies with each delivery model 

Data Input Methodology

A process led data input system enhances the quality of data while increasing compliance. It guides the end-user through subsequent steps to complete a specific process chronologically. This ensures that all steps are performed, data is correct and complete since it does not rely on the user to remember specific steps. Check with your CTMS vendor, if they utilize a process-led data input system. 

To select a quality software product as complicated as the CTMS, a predefined methodology to define and refine one’s requirement goes a long way in choosing a perfect technology partner!