Keys to Successful Global Implementation of Clinical Trial Technology
I’ve been at Greenphire for almost a decade, which in the world of technology, is almost unheard of.
In that time, I’ve held multiple roles and seen Greenphire expand our solution set to a full-service suite of solutions for the entire clinical trial lifecycle.
This evolution is reflective of how the industry has become more sophisticated in its delivery of patient and site-centric tools across the globe.
This delivery comes at the very nexus of complex areas of digital transformation, regulation, taxation, privacy and more – all of which clinical operations professionals must navigate in order to bring studies to market.
In my role, I help with just that – implementing solutions on a global scale for multinational pharmaceutical companies. Over time, we’ve amassed best practices for technology implementations, and I recently discussed some of these learnings for the virtual Clinical Trial Europe conference, together with Elisa Toma of CTA Focus.
If you’re in the midst of putting a clinical trial payment technology solution in place or considering making a business case for such a platform, you will want to review the list below of tips. They’ll help you prepare for potential questions and anticipated decisions that need to be made for international clinical research.
Let’s get started.
Country-level Requirements Gathering for Success
At the very beginning, it’s important to evaluate current processes, what’s permitted and how technology can support.
Let’s review five key areas for country-level requirements gathering.
- Payment Options per region. Are payments allowed? If so, what types? Are thresholds are needed? Understand the specifics of each country.
- Invoicing methodology: Not every country processes payments in the same way. It’s important to understand the current process to ensure a technology solution can support the necessary workflow.
- Tax implications: Whether for participant or investigator payments, tax situations will arise. Understanding the nuance and the technology’s ability to support it is tremendously important.
- Payment modalities: What options does the technology have for delivering payments? Can the recipient choose how they are paid? Are there differences to the overall process based on delivery method?
- Travel services: In some regions, payments may not be possible. To help alleviate costs, you can facilitate services. Be sure to gain insight into how different service offerings can work in each country.
Each of these paves the way for a successful implementation.
Ethics Committee (EC) / IRB Submission Process
Ethics committees (and IRBs) are responsible for ensuring that clinical research operate according to all national and international laws. Composed of doctors, nurses, social workers and community members, these boards join together to discuss the trials’ scientific, ethical and legal ramifications and to evaluate the benefit/risk factors for those involved.
Reimbursements and payments to participants are part of this process, with ECs reviewing the amount and method of payment to assure that neither presents a problem of coercion or undue influence. These schedules and details are to be explained fully in the informed consent form any other written information provided to participants.
However, it’s crucial that ECs understand the technology being presented – what it is and why it’s needed.
You should aim to provide clarity about the technology’s purpose and capabilities; it’s not just arbitrary. There is an important purpose on how and why certain information is collected, especially as it relates to data privacy. Ensuring the selected technology adheres to regional regulations and demonstrating that via submission materials will go a long way toward ultimate approval.
Keys to Site Adoption Success: Communication & Training
No technology is going to succeed if the sites are not willing to adopt.
- Communication: Notifying sites early and often when you are introducing a new technology is paramount to your ultimate success. Explaining what it is and not only why you’ve chosen to use it, but how it will benefit the site (and patients) improves the likelihood of sites agreeing to use it. To help when there are questions (which there always are!), it’s recommended to provide sites an internal expert on the technology who they can turn to.
- Training: Sites are being asked to use more and more technology. Providing training – whether instructor led or on-demand materials within the technology, is perhaps the most important piece when implementing technology – if the users can’t navigate through it, then all the time spent getting it ready could be for nothing.
To sum it up, any successful technology implementation requires the global expertise: both with the technology solution and the team of people guiding the implementation,. After all, it always comes back to the value of people and having regional expertise.
If you’d like to listen to the recording of the Clinical Trials Europe session, we invite you to do so here.
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