With the help of eRegulatory and eISF solutions provider Complion, the University of Kansas (KU) Cancer Center is looking to create a shared investigator platform (SIP) that provides a single standard method enabling the institution to work across the myriad sponsors it collaborates with on studies. Rick Arlow, CEO and founder of Complion, spoke with Outsourcing-Pharma about the technology, and how the integrated technology stands to help streamline the research process.
OSP: Could you tell us a bit about Complion—who you are, what you do, key capabilities and products, and what sets you apart?
RA: I founded Complion in 2013; at the time, I was pursuing my M.D. and Ph.D. in an NIH-funded medical scientist training program at Case Western Reserve University (Cleveland). When I experienced the numerous burdens caused by collecting regulatory documentation in physical paper binders, I developed a software platform that would replace the paper documents generated during clinical trials and instead leverage electronic filing. Thus, the Complion eRegulatory solution was developed.
Complion is the first and largest provider of eRegulatory software for clinical research sites. We address the burdens of regulatory document management helping clinical research sites own and upgrade their regulatory practices while enabling better monitoring and oversight by sponsors and CROs.
The platform helps establish consistent, predictable regulatory practices that are easy to understand, scale and track – even with changing staff or with staff that may be working remotely. Complion’s document and workflow management platform stores, organizes, and routes all regulatory documentation that may be involved in a clinical trial allowing for seamless, paperless processes.
Going beyond simply digitizing documentation, actual control of materials is made possible with the platform. Documentation is stored only once and is then electronically associated with any clinical study requiring that documentation. The result: Better organization and no duplication of material.
With easy-to-use tools to file, control, share, and centrally access regulatory documents, the need to manually move copies into separate folders is eliminated. Standard naming conventions for document types and preconfigured binder templates help create consistency across all sites and trials. This consistency helps reduce errors, consolidate processes, and control risk, improving the quality of work.
Information makes technology smarter to facilitate:
- Trackability – Every activity – views, signatures, modification, is tracked
- Automation – taking work out of staff’s hands – understanding automatically where information needs to be filed and who needs to have access to it
- Insight – the system provides understanding to you and tells you, without spreadsheets or manual tracking, the work that has been done and the work that still needs to be done.
How does Complion offer this?
- The system becomes the assistant. As documents are added, you tell the system about them. What are they? Who or what are they about? As you create a new study binder, you tell the system about the study. Once the system has that information, it automatically understands what new documents belong in what binders. No filing needed. No mistakes made. No dragging, dropping, or moving of documents. The system does all that for you.
- No need for copies. Because of this unique approach, you add a document once. Then, as it is associated with different binders, that same, one document appears anywhere you need it. One document. All staff are accessing the same document. Update it once. Add it once. No more version confusion.
- You can find what you need. Through years of gained expertise and our work with hundreds of sites, we have determined what information is important to add when managing documents and binders. This creates a consistent structure in how documents are stored in the system, and how they can be found within binders. Because of this structure, you can simply search by keywords, and the relevant documents immediately will be accessible.
- Security through information. As the identifying information is stored with the documents, the system automatically understands who should access what, through granular permissions, our team helps to set up during implementation. This means everyone has access to exactly what they need, and nothing more.
OSP: How did you come to collaborate with the KU Cancer Center on this—have their investigators used your services/tech in the past?
RA: The center has been working with Complion since June 2018 as their preferred eRegulatory platform. It has over 600 users in the Complion platform for more than 500 studies and storing 45,000 documents.
OSP: Could you share a little bit more detail about your eRegulatory solution, and how it will benefit the center (and improve upon what they had in place)?
RA: The KU Cancer Center is quite excited for SIP as it provides a single standard way to work across multiple, as well as their largest, sponsors. They were looking forward to the SIP integration, specifically for faster feasibility, and to also eliminate objections from specific sponsors and become more appealing to others.
KUCC wanted to partner with Complion to develop this integration that could be scalable across all their study trials and SIP sponsors. In their words, the integration will enable them to be live on SIP (thus achieving the forestated benefits) as it will greatly reduce, perhaps eliminate, the additional redundant work to file and prepare for monitoring visits.
They are also anticipating a further reduction in staff time associated with monitors as they will already have the information that they need. The best part in all of this is that KUCC won't have to do anything differently.
There is no need to remember a different way to file in a different system or have to manually identify what documents need to be sent prior to a monitor visit. Specifically, as documents are filed following their current standard process, the right and complete documents will be directly available within SIP in real-time with additional standard keywords (e.g. metadata) and naming conventions. In fact, in doing so, KUCC has identified a standard process that they can re-use to share across other systems.
OSP: Your announcement hints at future collaboration and/or expansion of the use of Complion tech at the center—could you provide any additional information on that?
RA: Due to various policies in place with our clients, Complion is unable to provide further details about ongoing discussions impacting future technology development. As with all Complion clients, we serve as a partner to KUCC, identifying any opportunities throughout the collaboration lifecycle to further expand processes, systems, and technology to assist with:
- Boosting regulatory and clinical staff productivity
- Accelerating study startup
- Eliminating patient safety and study conduct risks
- Increasing quality of study trials
- Containing costs
- Enhancing oversight.
OSP: Do you have anything to add?
RA: Specifically as it relates to the SIP integration: All of our site customers can utilize this integration if appropriate for their business use case, and as for our sponsor and CRO customers, they can utilize the integration with all sites on their trials.
There are numerous efficiencies that can be realized by using a Shared Investigator Platform when you're collaborating on Studies across sites/institutions. Complion's SIP integration is seamless for customers because it’s integrated into the overall document filing process.
Our customers don't have to go to a different area of the app or follow a different workflow to send documents to SIP. It's closely integrated with the document filing workflow they’re already accustomed to. We’ve also implemented tight controls over who at the institution has the permission to send documents to SIP. For regulatory managers, this helps to ensure the right documents are going to that shared platform.
Some other benefits: It reduces the operational challenges of clinical trials by bringing sites and sponsors together in one secure, common solution. It also offers a single point of access to resources needed to successfully execute multiple studies with multiple sponsors.
Sponsors who elect to use the SIP to run studies agree to share the same site information and leverage the same processes to eliminate many of the redundant tasks associated with conducting studies. A single sign-on provides access to sponsors’ site feasibility, study start up, training, and certain key safety communications and activities.
Additionally, single sign-on via SIP enables connection to many other technology platforms that sponsors use to conduct their trials --such as EDC, CTMS, eTMF, and payment systems. This eliminates the management of numerous username and password combinations and logging in and out of multiple technology platforms every day.
For investigators and site staff, there is less time required to log in and out of systems; fewer duplicate CVs and 1572s sent to sponsor after sponsor; less time completing duplicate training courses. This all equates to more opportunities for new studies and most importantly, more time for patients.
Maintaining data in just one place ensures the most up-to-date information is always available to clinical trial sponsors that are overseeing their clinical trials through SIP.
At Complion, we believe in the unique power of information. It is information, rather than the document that contains it, that is the critically important element of regulatory work for clinical research. At the end of the day, the documents that sites manage are critically important because of the information they hold. Always having the right information in the right place, at the right time, is at the foundation of providing the highest quality of service to sponsors.
Beyond document management, the Complion solution provides information management, supporting a level of quality, effectiveness, and ease of management that folders and binders alone simply cannot provide.
Sites tell us that they need better efficiency, and digitized work so that they can access things, and better support cross-coverage as needed.
To Complion that means better understanding, sharing, and accessing of information; better understanding of the work that already has been done and the work that needs to be done next, without the need for tracking in spreadsheets. It also means complete confidence, and proof of high-quality work at every audit, every monitor review, for every sponsor.
Complion provides unsurpassed monitoring benefits, which has garnered overwhelming industry support and has been accessed by more Sponsors and CROs than other eRegulatory platforms. Trusted by leading cancer centers, medical centers, hospitals, health systems, multi-specialty practices, and dedicated research sites, the platform helps clinical research sites meet the needs of the FDA, auditors, and sponsors.