Clinical Development Simplified, what does this actually mean?
21 September 2017
Having spent the last 17 years developing and enhancing our proprietary EDC tool, nowEDC™, we have seen the good, the great and the less than acceptable of clinical software and its deployment. Our vision has always been to deliver something exceptional to our end users –whether that be simplicity or complexity, we always strive to fulfil the need.
Since Datatrial began, our expectations of data capture and technology have changed significantly. Where data capture was basic data entry in 2005, it now includes:
- workflow management
- derivation of information
- integrated query management
- inclusion of eSource
- ePRO and so on.
In addition to this, we have created a technology for every discernible problem but unfortunately, these solutions are often poorly integrated and can become frustrating for the end user.
The average small to mid-size CRO interfaces with numerous solutions per project:
- Risk based quality management
- Labs, Safety
Alongside the business or operational solutions they need (timesheets, payments, expenses). This is then magnified if each customer chooses a different group of solutions. For a site, this situation is worse; for a high activity site, there could be 11 different systems live at any one time. If the CRO or site is already working with a solution provider at an enterprise level, the situation is improved. However, as a sponsor company, who wants to use the best technology for their specific requirements, an enterprise solution from one vendor may not solve this problem.
The Apple Effect
Today most people have a smartphone and a user account they routinely use to log in to multiple applications. Although the life sciences industry may not be ready to adopt a “sign in with Google” approach just yet, the users interfacing with our technology are very used to this. Coupled with the ease of use we are presented with (Apple have no doubt driven this), our expectations of technology are shifting, despite our highly regulated environment.
We are also influenced by our personal experiences when we choose technology;
- Is it compliant?
- Is it easy to use and understand?
- Can I buy it easily?
- Do I have transparency of price and some control over when this price changes?
Datatrial operate in life sciences, and more specifically in clinical research, but we are delivering to people who use software at work and at home. Our model has to become that of the best Software as a Service (SaaS) providers regardless of sector.
Can I access help easily and what does that help look like? Knowledge and support go hand in hand but more and more people want to be able to work things out for themselves. The self-service model for individual users is one worth exploring.
With all of this in mind and with many years of experience in data capture, we have seen and heard about the successes and the failures when technology is involved. We have pushed hard to ensure our customers have access to their data without having to pay more (extracts, reporting, and profiles) but we were still always deploying a new EDC URL per study, meaning a new password every time.
There are many solutions out there now offering single sign-on, which removes this issue immediately. That is where we started with our new technology vision. However, single sign-on is only a small (important) part of the challenge we have created for ourselves.
Clinical research is a collaborative practice;
...all have a vested interest in being part of research to improve outcomes for others.
This is a community of people coming together for a common reason. Granted the coming together has to be compliantly managed but nonetheless, communication and collaboration are a key part of the success of research. Once we had acknowledged that, our vision expanded and we created Nucleus.
With the emergence of Office 365 and the easy access to some powerful tools, like Sharepoint, the option is there to choose the enterprise solution for a relatively low cost. However, to ensure compliance, there is a degree of validation and often-complex configuration required.
Nucleus is ready to go as soon your organisation is created within the ecosystem and is core validated to industry expectations such as 21 CFR Part 11.
Every sponsor or CRO we speak to have a different set of challenges to overcome. Where your company is technology focused and of a certain size, enterprise solutions for managing vendors, payments, trials and applications may already be in situ. The economies of scale play into the hands of those companies with many users and buying power. However, many, many companies deliver scientific discovery and benefit to patients without that size and power but may have to make do with less than perfect systems with poor or no integration.
Nucleus is, in its simplest form, a collaboration platform.
Application (technology solutions) management is key and we have gone beyond our own technology now (EDC).
It is already set-up to allow you to send information from Nucleus/nowEDC to your chosen third party tool via a simple set-up interface. Your chosen CTMS sitting next to (or integrated with) your chosen EDC system and PV system at the project and program level. That is the start – nowEDC is an option too if that is your preference; the wizard driven build tool will be with you in Q2 2018. But what about Risk Based Quality Management or your central laboratory? Your chosen technology solutions in one place.
Nucleus provides integration opportunity via single sign-on and beyond to applications that do not originate within Datatrial.
Added to this we have compliant messaging – site users having access to CRAs; CRAs accessing their Data Managers and so on. Documents can be uploaded, shared and reviewed within the platform. CROs can manage their many customers; sponsors can manage their many vendors.
There is lots of discussion about patient centricity in clinical research and quite rightly. At the smallest level, thanking patients for their contribution and sharing outcomes with them when they take part in research should be the norm and not the exception. Taking this further, why not include patients in your clinical trial ecosystem. They can be protected (as expected by HIPAA and EU regulations) but can have access to and be part of the clinical research community that would not exist without them. Food for thought?
Who are you?
Nucleus should also be accessible to you regardless of whether you work as a free-lancer, a CRO or sponsor company. However, the more people connected within it, the more powerful it will become. As with all technology, the most important people are the users; we have aspired to build software that is easy to use and solves real problems.
So, what is Nucleus?
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Nucleus is the heart of collaboration. Nucleus is software agnostic; Nucleus is about community, Nucleus has been developed with decades of experience building software in the life sciences arena. Nucleus is clinical development, simplified.