Article authored and contributed to PharmaLeaders by Marc Leighton, VP of Product for Florence Healthcare
With the rise of decentralized technology across the clinical trial industry, real-time data sharing has become critical. If research sites, local physicians, trial participants, CROs, and sponsors can’t instantly share data with one another, remote or hybrid clinical trials will fail.
Data sharing comes with many benefits. Clinical research staff can collect data from diverse participants who may not be able to visit an academic medical center but can check in from home or their local doctor’s office. Research sites will also be able to collect data from patients in real-world environments, not just the controlled environment of the site, and they can share this data with sponsors and CROs in real time.
To reap these benefits, research sites, sponsors, and CROs need to think carefully about the data-sharing technology they choose, how they train their teams to engage in data sharing, and how they keep data sharing secure and compliant. Organizations looking to embark on data sharing can use the following roadmap to guide their technology implementation.
1. Choose the right data-sharing software
Many research sites focus on features when choosing data-sharing software. Though features are important, you also want to choose software from a vendor who will have a strong working relationship with you during and after the implementation process.
The software you choose will have an impact on your workflows and potentially even on your staffing. There is too much riding on your decision to leave a successful implementation to chance.
When you’re meeting with a prospective vendor, ask them:
- What their average implementation timeline is for data-sharing software
- Whether they provide user training
- If they can help you develop your Standard Operating Procedures (SOPs)
- Whether their SOPs are documented and compliant with your change control procedures
- If they offer a self-help library of training videos and informational articles
- If they provide customer support and allow customers to submit help tickets or request a new feature
- Whether they have disaster recovery and business continuity procedures
In addition to meeting all these requirements, your vendor should offer you both flexibility and standardization. Every site, sponsor, and CRO deserves data-sharing software with a structure, workflows, and user roles customized for them.
However, you also want your structure, workflows, and roles to be consistent throughout your organization. Software that combines flexibility and standardization lets you practice data sharing without confusion about where documents are stored or which team members can see which documents.
2. Ask about integrations
A single software program—even a single great software program—can’t perform all of the functions you need for data sharing. You may have to collect data from a variety of sources, like wearable devices, patient apps, doctors’ offices, and the research site.
You may also need to store data from patients’ electronic health records and data about the investigators conducting the research. Then, you need to be able to securely share all of that data with sponsors, CROs, and other research sites.
This is why interoperability is critical. Data-sharing software that’s part of a closed system only works with software from the same vendor. If that vendor doesn’t make a piece of software you’re looking for or you don’t like how one of their programs works, you’re out of luck.
Software with an open Application Programming Interface (API), by contrast, can integrate with any other software that has an open API, no matter which vendor it comes from. Ask your vendor if they have an open API and if they’re willing to help you set up integrations with other programs so you can share data between them.
3. Build an operational change management strategy
When you transition to sharing data with other sites and sponsors in real time, you need an operational change management strategy. An OCM strategy consists of three parts:
- Clear processes (that mitigate risk and encourage change)
- Defined milestones (key performance indicators)
- Measurable results (templates, forms, checklists, quality measurements)
These processes, specific milestones, and methods of evaluating your results should be written down and shared across all the members of your team who will practice data-sharing.
Talk to your team about how following the change management program will add value to your company. Your vendor should provide case studies to help you prove this. If your team sees evidence that new software will help them share data with sponsors quickly so they can have more time with patients, they’re more likely to buy into the change management plan.
4. Train your team members on data-sharing
Before you train your entire organization, you’ll want to train a small group of “Project Champions,” people who know the new data-sharing software well and can help other team members use it. The Project Champions could come from Regulatory, Quality Assurance, IT, Compliance, or any other departments that might manage data. They’ll receive in-depth training on roles and permissions, workflows, and document management.
Look for a software vendor who’s willing to lead hands-on, live training for your Project Champions team. Ideally, the vendor or your Project Champions could also provide live training for other team members. Since live training isn’t always possible, however, your vendor should offer recorded videos, comprehension quizzes, virtual walkthroughs, or written training documentation too.
5. Ensure you have support after implementation
Your data-sharing roadmap shouldn’t end at implementation. You’ll always have new members joining your team, and you may have questions about advanced workflows or integrations years after you begin using your software. Ask your vendor how they can help you navigate your data-sharing software beyond the first few weeks.
In addition to self-guided training options, they might offer help desks, customer service teams, product release presentations, or open office hours. They should also let your team submit requests for new features to make sharing documents and data easier.
6. Share data securely and ethically
Data-sharing helps more healthcare organizations get involved in clinical research. But because clinical trials are so highly regulated, many research sites worry about whether they can use data-sharing software while complying with international and federal regulations.
The good news? You can find data-sharing software that complies with ICH GCP, FDA 21 CFR Part 11, GDPR, HIPAA, and other relevant requirements. Make sure you ask for documentation from the software vendor about how they follow these standards.
A compliant vendor will help you create your change management strategy and update your SOPs to reflect your switch to electronic records. An SOP consultation should be part of any data-sharing software implementation.
Finally, you should make sure any participant who will have their data shared understands what is happening and has consented to it. Update your informed consent documents to show that data may be shared electronically through secure software, and explain to your patients what that means. Although sharing data is wonderful for clinical research, data sharing should always be rooted in compliance and ethics.
Create Your Own Roadmap to Real-Time Data Sharing
With a software vendor who wants to serve as a partner, thorough training, and an eye toward compliance, clinical research organizations can embrace new technology for data sharing.
About the author: Marc Leighton is Florence Healthcare’s VP of Product, joining the team with a rich background in global healthcare and delivering innovative solutions to customers. Before coming to Florence, Marc served as a Strategy Partner for Cleveland Clinic, acted as Global Product Director for GE Healthcare, and held various leadership positions in a Revenue Cycle consulting and operations capacity.