With the holidays just around the corner, now is the time when all the boys and girls out there start to make lists of what gifts and goodies they’d like to see under the tree. While the people who are reading this blog are likely too old for fire trucks and dolls, nothing beats the feeling of getting exactly what you want on Christmas morning.
With that feeling in mind, we decided to make a wish list for the good folks of the clinical research world. We thought long and hard about it, and we put together a pre-written wish list of the key characteristics you’ll need in your eTMF that will have you excitedly screaming “Thank You Santa!”
1. The Savings of a Cloud-Based Tool
With any technological solution to a problem, there is a need to invest in IT and the people resources to maintain that infrastructure. However, unlike most emerging technologies, cloud-based solutions bring with them a wealth of cost savings, localizing IT resources remotely and leveraging the power of the internet to access them.
A cloud-based eTMF on average costs about 35% of the cost that is required to maintain a comparable on-premise eTMF; when taking into consideration the cost of hardware, IT staff, and utilities required. By lowering operating expenses, this means you have more funds to allocate to studies, people, and your organization in general. Think of this as your ‘’Batteries Included’’ gift.
2. An eTMF Based on the TMF Reference Model
Due to the total amount of data being input and accessed on a regular basis, the TMF needs to be well organized from day one in a recognized model. Thanks to TMF Reference Model group, there’s no longer any guess-work required as to how it should be done.
An eTMF pre-configured around the TMF reference model means that day one is about artifact capture and study delivery, instead of a protracted set-up process. No one wants to wait until April to play with their toys and why should you?
3. Out-of-the-Box 21 CFR Part 11 Compliance
Remember the phrase “No Assembly Required”? There’s a great feeling in knowing that you’ve chosen a solution that requires no additional proving. An eTMF that is 21 CFR Part 11 compliant for both electronic records and electronic signatures will ensure that the FDA and other regulatory bodies will be just as happy with your choice.
Wet ink signatures have long been the standard to prove that a document was reviewed. Electronic signatures go beyond this, proving time, date, and true verification of a complete review in a fraction of the time.
4. Proper Filing Conventions Lead to Traceable Documents
Building a proper TMF structure is just one part of a well-oiled TMF machine. By integrating predefined naming, metadata, versioning, and filing conventions, the data trail is easily navigable and understandable.
This might not feel like it’s necessarily a gift for you, but it always feels nice to give to others. If inspectors feel that they can track the progress and evolution of a document’s compilation through a proper audit trail, they can feel confident in the process you have followed to get files to their current state. A comfortable inspector is a gift that will pay back dividends in the long run.
5. Intelligent Search and Filtering Functionality
A Trial Master File holds a huge amount of data and documentation that needs to be managed and maintained by a variety of stakeholders throughout the clinical process. As organized as any system might be, there will always be situations where your team will need to jump in, locate a document, review, and move on quickly.
By offering comprehensive search functionality, jumping to the exact file you need is as simple as knowing the site, the author, the file number, or just a keyword. Similarly, the ability to filter documents based on the completeness state gives oversight into where documents are in the approval process, and what might be lagging behind.
6. Familiar User Interface
In many cases, learning the nuances of a new interface isn’t a gift, it’s more like a lump of coal you really didn’t want. There’s a time investment in mastering tasks such as importing documents and developing complete processes and workflows.
However, building technologies on top of common interfaces, that the user is comfortable with, eliminates a huge chunk of the learning curve and makes on-boarding much easier. This can be as simple as using some common sense, regularly-used iconography to the integration of a platform such as Microsoft’s SharePoint that replicates the feel and functionality of the Microsoft Office suite.
7. User Configurable Workflows
Not every department and company follow the same processes. There are clinical, regulatory, and quality teams, all with their own quirks and processes driven by unique needs and requirements.
Providing the flexibility to customize process workflows allows your team to dynamically drive the document lifecycle to the beat of your own internal drum with centrally managed tasks, significantly speeding up the creation, review and filing of TMF content. This is like getting that shiny new electric train set on Christmas day and building your own route around the living room.
8. Flexible File Contribution Options
If a tool is difficult to use when you set it up, it’s like someone forgot the batteries. Importing documents into an eTMF is crucial to the TMF process and if it’s tough to do, it’s just as heartbreaking as missing the AAAs.
A file import engine that includes a variety of options including a classic upload dialogue, drag and drop import, a clinical inbox allowing emailing documents directly into the TMF, and simultaneous bulk upload and indexing offers users of all levels and requirements the tools they need to get documents into the eTMF as soon as possible.
9. Powerful Business Intelligence Dashboard
Wouldn’t it be nice to just log-on and see exactly how your TMF is progressing, at any time? Want to know if there are tasks outstanding, and who might be responsible for them?
The metadata integrated into files when importing then can be leveraged to offer your business insight into how the system is being used, who is producing, the quality of the work being provided, and how close certain processes are to completion. The best part of this gift: no more manual excel based trackers with multiple versions being shared on a weekly basis.
10. Integrated Authoring & Collaboration Tools
With Microsoft Office integrations, users of eTMF Connect can create documents from templates directly from the workspace. After saving, they are instantly filed, versioned, and ready to be reviewed and edited by colleagues, and even collaborated on in real time.
Surrounded by friends… not a bad way to start a new year.
Bonus Stocking Stuffer: Cross System-Integrations
No holiday season is complete without an unexpected surprise. And while it might not be surprising that our eTMF Connect offers the ten features noted above, did you know that Montrium Connect is also on the nice list because of how well it plays with others?
While full interoperability and compatibility between all systems is still while away (cue TMF Reference Model Exchange Mechanism), it would still be nice to have the ability to share information between your eTMF and CTMS or Regulatory EDMS in order to streamline processes and pass key data to different partner departments and organizations.
Even better still are systems with a broader integration feature set including API hooks. This is where things get interesting and will mean an even greater ability to integrate disparate systems with each other including eTMF, the above-mentioned EDMS systems, and potentially even leading CTMS, IRB or EDC systems.