Addressing Compliance Requirements at Tohoku University Hospital

Case Study: Tohoku University

When the Clinical Research Data Center at Tohoku University Hospital needed a more efficient and effective way to manage clinical and quality documents, they chose Agatha.

Located in Sendai, Japan, Tohoku University Hospital is a general hospital that belongs to a national university corporation. It has a 190-year history, the longest among university hospitals in Japan. Designated as a Clinical Research Core Hospital, it plays a major role in conducting global standard clinical research in accordance with the Medical Care Law.

The Clinical Research Data Center assists in managing data and documents for clinical research projects at the hospital. They offer consulting services related to quality control and statistics to ensure the reliability of the clinical results, as well as support for investigators in creating protocols, CRFs, entering and assigning subjects, progress management, data management, monitoring, statistical analysis, creating reports and other tasks.

For the Center, managing documents manually for many research projects imposed a great workload. Individual projects had their own document management schemes and folder structures and tamper prevention and version control were not ensured systematically. The result was high costs, slow processes, and compliance risks.

Addressing Requirements with Agatha Applications

When the Center set out to look for a solution, the goals were to streamline operations, enhance compliance, reduce wasted time, and enable collaboration with external study stakeholders.

After a review of options, they chose Agatha and implemented Agatha’s applications for managing SOPs, quality processes, and clinical research documents.

Implementing Agatha applications addressed all their requirements and allowed the Clinical Research Data Center to achieve ISO9001 certification. The applications embed best practices and required procedures, a big improvement over trying to ensure consistency by imposing rules on staffers to do so manually.

Also, because they support many investigators and research projects, a unified approach using Agatha means the Center can be more efficient, provide more services to more projects, and help accelerate each study.

A Q&A with the Prof. Takuhiro Yamaguchi, Director of the Clinical Research Data Center, and Junya Kimura, Medical Information Expert

How did you manage these processes and documents before?

Previously, we managed documents and files on Windows file servers in the data center. This posed a great burden on us, as we had to enforce rigorous rules for filenames and storage, and what’s more, we had to keep the original paper documents for some of them. So, we decided to deploy a system that has version control and anti-tampering features to enhance our document management scheme.

And how do you use Agatha applications?

We use Agatha in two areas. One is our QMS documents and SOPs, and the other is research project documents.

We used to keep paper documents as the originals for QMS documents and SOPs, and we would save electronic files chronologically, our naming rule being ‘file server + document name + date.’ With Agatha, the staffers create documents, upload them to Agatha, and the director approves them on the system. Agatha doesn’t allow us to edit wrong versions or intentionally tamper with documents, because all transactions are logged in the system. So now, we can secure the reliability of documents automatically, rather than manually as before. We use an electronic signature for documents.

How are things different now?

Now, staffers can view the latest versions of QMS documents and SOPs on Agatha. We’re currently shifting from paper to digital for clinical study documents. We conduct projects that are already underway as before and start new projects on Agatha. We are now able to manage documents of all projects systematically by a standardized scheme, as it applies to all projects, using the same folder structure across them. Before each project, or each staffer had their own storage locations and folder structures, but now we have a standard management framework. So, it’s now easier when a new staffer is assigned to a project, as everyone knows where documents should be.

Currently, our staffers upload documents sent by researchers onto Agatha to manage them there. But we’re also planning to implement new processes so that investigators can upload, review and approve documents themselves.

What benefits did you get when you started using Agatha?

The great thing was we were able to share documents from anywhere, without a hitch, when the Tokyo Office of Tohoku University was launched in July. We believe it would have been impossible to share documents with the Tokyo Office without Agatha, and this could have created the bottleneck.

Also, now we have ISO 9001 certification, and our staffers are far more self-aware about document management now. Having a DMS made some things effortless and automatic, while it made us do some things consciously. This made us think about document version control, storage, and ID and password management, and other security matters.

For example, the official document approval procedure requires drafting, review, and electronic signature for approval. We’re now fully aware of the meaning of approval and signature.

By having Agatha, we also became able to systematically manage documents by making use of the system’s features such as version control, anti-tampering, and approval logs. But it goes beyond that. It was a great gain for us that the entire staff came to understand the benefits and risks of document management and systems from using Agatha… so the impact was not just through processes, but also in the awareness of the importance of those processes by the team members.

Download the Tohoku University Customer Story for your reference.

Buying Enterprise Software? Don’t Ask for a Sandbox

a Sandbox is for kids, not enterprise software

I try not to count them, but I think I have been in the enterprise software business for about 35 years. And if it is more, please keep it to yourself. One thing I know is that we are all too old for a sandbox.

The buying and selling of software for businesses has changed little over the years. Trade shows and site visits create leads, salespeople call, demos are scheduled, and proposals are written. Sometimes customers ask for a period in which they can try the software out, like a test drive on a new Honda Accord. And as they say, “not that there’s anything wrong with that.”
I am all for trying before buying. Just don’t ask me for a sandbox.

The term sandbox evolved in our industry to mean an instance of the software that the prospective user can have access to and “play in” with dummy data. Here is my issue: No one should play with enterprise software without appropriate orientation, some training and a set of realistic scenarios. I am sorry, but this is not Candy Crush, this is business software for specific processes.

I am on a crusade for how we in the enterprise business applications market buy and sell software. I want EVERY PROSPECTIVE BUYER to use the software first. As a SaaS solution, we can create a new instance and provide credentials in minutes. HOWEVER… our pilots, for which we do not charge, include three full orientation, training, and Q&A sessions. We make parameter changes to the environment to mimic the customer’s needs. And we have an expert available 24/7 to jump in and help the users during the pilot period.

Excuse my English, but this ain’t no stinking sandbox. I don’t want users to play with the software; I want them to experience it in real-life scenarios. And I want to use the pilot period to collect information on any parameter changes that will be needed to transition into production use.

This way, a pilot project provides the benefit of accelerating the actual project. It provides momentum and a head start, so after the decision, it is not a matter of starting over. The PILOT is just the first phase of the PROJECT!

To me, this is how the current generation of modern business applications should be bought and sold. And the reason may surprise you. As a vendor, if my software is not a great fit, I actually do not want you to license it. This is SaaS software, with an annual subscription, and if it isn’t right for you, you will get frustrated, require a lot of support and chances are you will not renew your subscription.

No. I am looking for serious buyers willing to invest the time to exercise the application thoroughly. For those buyers, the sky’s the limit. No cost for the pilot, a choreographed experience with training, check-ins and unlimited support — a one-on-one session every day of the pilot if you want!

So there will be no sandboxes. Sandboxes are for children. If I have it my way, in the future we will all be buying and selling enterprise business applications as adults, with comprehensive pilot projects as the basis for the decision. Even if it takes until I have been in this industry for ANOTHER 35 years 🙂

Ready to learn more about Agatha’s approach to software trials for eTMF, SOP and more? Sign up here.

When it Comes to eTMF, it is All About Usability

Usability in trial management software

In choosing a title for this blog, I REALLY wanted to call it, “It’s Usability, Stupid.” But I recently had my two young nephews here, and they told me that “stupid” is a bad word and I should not say it… so there you go.

James Carville coined the phrase “it’s the Economy, Stupid” in 1992 to guide Bill Clinton’s presidential race. The blunt phrase aptly captured that there is one thing that trumps all in presidential elections.

And so it is with implementing and adopting eTMF solutions. Vendors focus on features because that is one way that customers compare systems. It is kind of like new features on a car where the latest version of lane tracking becomes a differentiator – vendors are eager to add a new feature that another vendor does not have.

But here is the thing: Features do not matter if users are not using the software. A new feature used by one user provides little value if a sizable percentage of users are not using the system at all. It is the 80-20 rule in action. In every software system, 80 percent of the users are using 20 percent of the features and capabilities — or are avoiding the system altogether because it is a pain in the posterior (another nod to my nephews).

With software, great design and usability is the single most important factor in determining return on investment (ROI), because fast and effective adoption drives value. So, in every way, “It’s usability, stupid.”

What does that mean in practical terms? It means that when choosing an eTMF solution, trying it first is an essential step in the selection process. Insist on a period when you can work with the tool, using it every day for a few weeks to create new artifacts, route items for approval and do quality checks. Include the CRAs and get them excited about the application. Choose a system that is easy to get started with and easy to adapt to your needs. Avoid the products that require months of work to implement.

Then you need to focus on evangelism during the rollout. Identify the leaders who are adopting the new solution quickly and recognize them enthusiastically and publicly. Identify the laggards and reach out to them quietly and privately to identify the obstacles they are encountering. This is a critical time for investment in activities that will encourage use and prevent frustration.

Of course, the starting point has to be an eTMF system with a great design and user experience baked in — that goes without saying. But it also goes without saying that some solutions available sport a real retro feel… a cool thing in a car but with software — not so much. 🙂

At Agatha we make sure that every application we build is easy to use so you can focus on your work, not using the application. Want to learn more? Sign up for a trial and we can get you set up.

The Lines are Blurring Between Clinical Trial Management Software Categories

clinical trial software

I find myself back in the world of life sciences software after an absence of several years, and as with any return to a place of one’s memory, my reentry has sharpened my vision, revealing patterns I may have missed if I never left.

One thing I see is how clinical trial software has evolved with separate and distinct solutions for different aspects of managing clinical trials. There is Electronic Data Capture (EDC) for collecting trial data, Electronic Clinical Trial Management Systems (eCTMS) for planning and managing the trial, and electronic Trial Master Files (eTMF) solutions for managing trial documentation. And there many other solutions for enrollment, managing payments, and handling the actual medications.

But here is the question that jumps out at me:

Why have we evolved these distinct categories of trial management software?

Building Clinical Trial Software – The Old Way

Sometimes, the separations make perfect sense to me. When different users have different needs and work through different processes, good design says the applications they use should probably be separate.

But sometimes the dividing lines are based on differences in technology, not the needs of users. Specifically, there have evolved distinct and separate categories of software not based on the needs and roles of specific groups of users, but on the different types of information that you need to manage in a study.

Here is what I mean. EDC software is all about data: the information at the heart of the EDC solution is highly-structured data… that is, quantitative data, structured for analysis.

Conversely, the focus of eTMF solutions is on documents, not structured data, and there is a separate category of solutions for that area using document management technologies.   Additional solutions in the CTMS category focus on managing the schedules and processes of a trial.

Notice the way things evolved? One category for data, one for documents and one for the schedule and processes.

The lines of demarcation are not necessarily where they should be, and I think we are starting to see a “refactoring” of functions as different solutions evolve and reflect the needs of specific users in specific roles.

Building Clinical Trial Software for Users – The Right Way

We do not need to separate functions and activities because the type of information is different. We need applications that combine structured data and unstructured data, database rows and columns with metadata and workflow processes in easy-to-use interfaces designed around a user’s roles and tasks.

Returning to the world of life sciences software with my sharpened vision, I am happy that this shift is happening. As I look at current eTMF solutions like Agatha’s, I see an application that combines the management of documents with a forms-based model that collects and stores structured information, and then adds workflow capabilities to define processes. In one system, a user can create and manage the documents that define the TMF but also manage the processes relating to the documents and collect and store structured data through forms-based entry.

Today, instead of a limiting factor, the technology available to us enables this ability to mix information types in an application. That’s because even though the regulatory authorities still require specific documents in specific formats, we can work with structured data to facilitate processes and reuse and then generate the documents from that data when we need them.

The ability to work in this way, with structured data, documents and other types of data, means that we can design better applications. And when I say better, I mean applications that reflect exactly the processes and activities of a specific set of users.

As this trend accelerates, I think we will see software solutions that increasingly group functions based on roles and tasks. These applications will be easier to use, resulting in users adopting them more quickly, which is essential given the economics of clinical trials.

And the best part is that we are just at the start of this shift. I realize we are at the dawn of a new generation of solutions that are more aligned with user roles, incorporate advanced AI technologies and adopt the best user interfaces.  It is an exciting time, and for me, it is good to be back 🙂

Interested in learning more about Agatha’s solutions? Drop me a quick email and we can chat.