Adopting clinical operations software can be an enormous undertaking, and there are many aspects that a sponsor, CRO, or clinical site will want to address before taking this step.

1. Do Your Research Before Adopting Clinical Operations Software

Start with defining your requirements. To do this, you need to get key stakeholders together to address some questions. Be sure to include everyone that may need to work in the new system: the secretary may use it for scheduling; the CRC will enter data; the finance department will create invoices and reconcile payments; the recruitment team will review eligible patients; the executive team will make decisions on the reports it generates, etc.

Work with the stakeholders to address questions such as:

  • What pain points do you need to solve?  
  • What capabilities do you want that you don’t have now?                 
  • What type of security or storage will the technology have? 
  • Will the system be compatible with your current systems?   

Prioritize the answers to these questions. Keep in mind that you may not get a solution to each problem with a single vendor.

Next, map out your current system and observe the sequencing you currently use. Where are the most errors? Where is the most time spent? Ensure you understand your current situation to understand where technology can help you improve.

When doing your research on vendors, be sure to assess vendor roadmaps. This assessment includes the individual vendor product roadmaps and your site’s plan for technology now and in the future.

This is likely not the first technology you’ll add and won’t be the last. Taking the time to map out past, current, and future technology will save you time and money as you move towards more technologies. 

A few questions you may need to answer:

  • Will planned software purchases in the future work with your current technology? 
  • Will new technology require you to replace old? 
  • If you have to put in new phone systems, upgrade servers, or purchase all new computers for your staff, you’re looking at a heftier price tag.  
  • Will new technology build on each other as you add it?  
  • If you purchase an eSource solution, how will it integrate with your current CTMS system to capture all charges?

Additionally, ask the technology vendor these same questions. Ask if they have plans to integrate with any of your current technology in the future. What strategies for their technology are they working on? Are there enhancements in the future that are attractive and may weigh in on our decision?  

Years ago, when looking at an eSource solution, I chose to go with a vendor that initially only had eSource but had plans to add CTMS, eRegulatory, a recruitment module, and stipend cards in the future. It worked well for my site as it allowed me to take a phased approach to technology, and I was able to spread my technology purchases out over a few years. I felt the change management that comes with adding new technology was more comfortable to manage with this model.

Also, understand their support and customer service offerings. We’ve all had experiences where customer service has decreased below our expectations once the sale is complete. We certainly don’t want that occurring in our business. Be sure expectations for ongoing support and maintenance are clear for all parties. How do they handle requests for new features by their customers? What is their response rate for IT requests? Who is your point of contact once the salesperson transitions off your account?

2.  Perform a Cost Analysis of Clinops Software

Cost is at the top of everyone’s list when evaluating new technologies. There are two ways to look at the cost of technology.

Implementing a New Technology Solution

When you implement a new technology solution, you add a new line to your budget worksheet that wasn’t there before. To offset this new line item, assess where you are reducing or eliminating other costs. For example:

  • How much will you save on paper and charts?  
  • How much storage space will you get back? 
  • Do you increase the convenience and efficiency of multiple staff members working in a patient’s chart simultaneously? 

By putting a value on these questions, you can determine if the benefits of the technology will offset the cost of the software. The most significant cost savings will likely be in staff time as new technology ideally automates or eliminates steps previously done by your staff.

When doing your cost analysis for adopting clinical operations software (or any software), try to account for the steps you can eliminate in your current processes, the increased efficiency you will gain, and the access to data you are acquiring to help make decisions down the road.

Upgrading Existing Technology

Suppose you’ve already implemented a technology but are thinking of upgrading or switching to another vendor. In this case, you need to look at the time it takes to change systems, which can be expensive.

Onboarding fees for the new vendor and the time it will take to train staff on the new system will be the most significant factors in our cost analysis. Assess what you’re gaining with this different system compared to your current system and ensure it’s worth the cost.

In both cases, you want to ask several questions. 

  • Will business processes improve with the new technology? 
  • Are we going to be able to create source documents faster?
  • Will we be more efficient and improve our coordinator error rates?

3.  Determine if the Technology is Worth the Cost

Technology should pay for itself with enhanced workflows, decreased errors through automation, metrics tracking that allows for data-driven decision making, and optionality in the workflow. If technology simply provides an electronic version of a paper process with no added search abilities, connection, etc., think twice about adopting it.  

Take a PDF form-fill program that allows staff to enter data on laptops, for example. It is inexpensive to implement, saves on binder space, and even allows for some eSignatures. However, when evaluating the solution further, you find that it’s not 21CFR11 compliant because it doesn’t provide an audit trail, two-factor verification for eSignatures, or secure storage with redundant backups.  

You also find that it doesn’t allow you to search by the data fields or interface with your CTMS program. It doesn’t cut down on protocol deviations because a PDF may not alert you to missing data fields or have auto-alerts built-in for incongruent data. While it may look more pleasing on your budget worksheet, you’ll find it doesn’t provide necessary enhancements over a paper solution to make it worth the cost.

On the other hand, good technology will provide edit checks for source document entry. Typos or even entries that may exclude a patient are automatically highlighted, alerting the CRC to address the error immediately rather than at a routine monitoring visit or via a “late entry” note.

Source data entered into the system then goes directly into an invoicing interface, so the finance team knows, in real-time, the current accounts receivable, eliminating the time and error-prone need for the CRC to update the information. The technology can also issue a payment to the patient’s stipend card when the visit is complete, eliminating the finance team’s process to issue a check.

4.  Interview Current Customers of Clinops Software

In addition to asking the above questions of your clinops software vendors, be sure to ask them about customers already using the product. 

Referrals are helpful in a few ways. First, the salesperson isn’t an end-user of the product. While knowledgeable about capabilities, salespeople don’t typically have experience using the product. Asking questions of an end-user will enlighten you more than the salesperson who may be following a scripted pitch.  

Second, end-users will also bring up topics you didn’t even think to ask about. It’s a bit of “you don’t know what you don’t know.” Use open-ended questions and be sure to ask about areas where their transition to the software didn’t go well (you may learn from their mistakes). Ask for helpful hints and their favorite features of the system. Also, be sure to ask where the system could be more robust. At this point, you have the salesperson’s ear so bringing this feedback to them often spurs them to make enhancement requests to their developers if they believe it will land more sales.

Time to Put Your Plan in Action

Follow these four tips for adopting clinical operations software and you’ll have the best chance at selecting and implementing solutions that work best for your company.

If you want to learn more about clinical operations software for sites, check out our ebook on the subject.


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