Q&A: Leveraging technology to automate patient, site and trial logistics fulfillment

Q: What does it mean to automate something?

Automation is the process of using technology to do tasks without the involvement of a human. This can involve utilizing software to perform administrative tasks like data entry or analysis, and using machines to carry out transfers of data. Automation can boost productivity, decrease mistakes, and free up human workers to spend their time on more difficult tasks.

Q: What are some of the administrative tasks involved in running a clinical trial?

Running a clinical trial entails a range of administrative responsibilities, such as:

1. Protocol development: drafting a thorough strategy that specifies the goals, layout, and methods of the study.
2. Budgeting and invoicing: core financial aspects of the trial, including budgeting, forecasting, invoicing, and supplier payments.
3. Site management: site selection, contracting, grant payments, ongoing support
4. Patient management: recruitment, retention services (scheduling, communications, travel, reimbursements, stipends)
5. Ethics review: an institutional review board (IRB) or ethics committee must review and approve the trial to ensure it’s being conducted in an ethical and lawful manner.
6. Monitoring: keeping tabs on the trial’s development and ensuring that the protocol is followed.
7. Data management: the process of gathering, storing, and managing trial-related data.
8. Monitoring: track trial conduct to ensure outcomes are on target and safety issues are reported
9. Closeout: archiving trial records and delivering final reports to the appropriate authorities.

These are only a handful of the numerous duties that could be involved in managing a clinical research. The type, scope, and complexity of the trial will determine the precise administrative responsibilities.

Q: What are the areas of “automation” that Block Clinical is focused on?

Block Clinical’s focus is on delivering services that are Site and Patient centric; these are services that reduce burdens, and improve their overall experience of clinical trial participation. Right now, we’re just working on the plumbing, the infrastructure that can scale with a clinical trial industry that is becoming more and more complex. More suppliers. More data. Decentralized this, hybrid that. There is more need than ever for well integrated systems, processes, and policies that standardize how research sites, patients, and suppliers are supported by a trial Sponsor.

Our business was initially focused on patient support – travel, stipends and reimbursements, and providing a single point of contact throughout their journey. We’re automating workflows such as travel bookings, payments to suppliers, and payments to patients and caregivers. We’ll continue to integrate suppliers that support patients, whether that’s at their homes, or at the research site and facilitate data and transfers of value in real-time.

Now, we’re working hard on the financial workflows of clinical trials. This includes budgeting and contracting, invoice approvals and payments, real-time reporting, and spend and accrual forecasting.

With these two basic layers of integrated suppliers, and financial connectivity we can ensure everyone is getting paid quickly (immediately in some cases) and accurately, which empowers all parties to deliver their highest quality product. In turn, we can share this data with Sponsors so they can best manage cash flow to ensure timely payments. This is the beginning of a well oiled machine.

By using technology to automate service and financial workflows, clinical trial operations will become more accurate and efficient while spending less money and requiring less manual labor.

Q: What does the future of “automation” look like for Block Clinical?

1. A large network of integrated suppliers: this includes research sites, travel companies, home health, and everything in between. If a patient or research Site needs it, we’ll make sure they receive “it” in the most efficient way possible while protecting PII, sharing only what is needed by each unique supplier, while automating the invoice, approval, and payment processes.
2. More “activity” data: for us this could be patient status, visit, or survey data that tells us “what” happened. Did a patient enroll, was a visit scheduled or completed? We read data out of other systems (EDC, ePRO, CTMS) and apply automation. Communicate to a supplier to do something? Check. Monitor delivery of the service and report back to Sponsor that the service was delivered? Check. Overlay supplier contracts and automate the invoice and payments process? Check.
3. Forecasting: what will be spent in the coming weeks, months, and through the end of the study based on real time activity, contracts, and spend data? Check mate.