Clinical trials are vital components of research to help humanity. It’s how we get vaccines and life-saving medicine that helps many of us navigate life.
But managing these trials and the processes that come with them is no easy task.
With so many moving parts and a need for risk management, it is no wonder clinical trial managers often find themselves dealing with difficult situations.
In this article, we’ll go over the challenges that documenting a successful clinical trial process faces, and how they can be easily simplified with the right platform.
Challenges of Managing a Successful Clinical Trial Process
Managing a successful clinical trial process is difficult. Not only are there very real humans being put through this process, but there are also great risks to them and to the organisations behind the trials.
Having advised and worked with clients in this area iin the last few years, we’ve been able to determine some key challenges faced.
Need for documentation
Documentation is vital for any part of a clinical trial to be successful. Whether it is for preparing for the trial, during the trial, or after the trial, it is imperative that every part of it is documented correctly and accurately. Documenting it all is necessary to ensure patents go through later on, or scientific findings can be corroborated and presented for future study.
All relevant trial documentation has to be easy to find and understand at various stages of the overall process for it to be accessible and useful to everyone involved.
Often trials do not have a centralized documentation system. This makes information difficult to find and slows everything down, as it is essential to ensure the clinical trial process is followed to the letter.
Clinical trials do not shy away from using technology. After all, what’s being tried will have been made with top-of-the-line tech.
The problem can be with how the trial is documented in the first place. Not having a platform that is fit for purpose can mean that your organisation is let down by administration and bureaucracy after spending millions on incredible research or technology in the first place.
Teams may be trying to manage using spreadsheets or other document-gathering applications based on what they have always known. But this doesn’t always solve the problems.
Lack of standardised notation
The problem with mapping your own process management system is that not everyone will understand it. It is often not standardised, making it difficult for newcomers or others to read and interpret it.
Clinical trial managers building their own systems and notations for their processes with the technology they have is great so long as that manager is retained. When the trial is scaled or the manager leaves, it’s back to square one. Or, if someone new arrives or the team grows, the way they interpret certain parts of the process can be different, meaning the process is no longer clear and there is no standard, uniform way of getting things done.
This is the last thing you want to happen with something as sensitive as a clinical trial.
As a result of this lack of standardisation and easily accessible information, your organisation is wasting time
Clinical trial managers are constantly retracing steps employees or others have taken to understand what happened at a certain point that diverged from the norm.
The process that you have carefully mapped and monitored suddenly becomes useless as interpretations vary and the data becomes stale. In an area of industry where risk management and clarity are so vital, this is not something you can afford. The importance of having your best practice processes documented is essential.
Therefore not only is this wasted time, it is also wasted money.
Lack of accountability and clarity
A large part of the reason for this is that there is also a lack of accountability and transparency with accountability.
Clinical trials are a big deal, and you can never prepare for all eventualities. For compliance and risk management purposes, and also for the day-to-day actions during the trial, it is absolutely necessary to know who is responsible for what.
If you do not know this, the entire process can easily grind to a halt waiting for sign-off, leading to lost time, or an action never taking place because no one is willing to take responsibility for it.
Lack of clarity when it comes to accountability is one of the easiest ways to ensure your process does not move forward.
The process is not followed correctly
All of the above points essentially lead to this: the established process is not followed correctly during the clinical trial.
Often because it is not clear what that process is.
Mistakes happen constantly, steps are missed or dismissed from some parts without prior consultation, and there is a lack of compliance and responsibility slowing everything down.
And when the process is not followed during a sensitive situation such as a clinical trial, it is very easy for the entire thing to be questioned or invalidated and the data not viable.
This means lost time and money for all involved parties, and a need to set up everything again. Only to be faced with the same challenges.
Simplifying the Clinical Trial Management Process
Clinical trial processes and their management should not be complicated.
With the right tools and platform, they are not.
We’re obviously biased, but only because we know we are already making a difference in clinical trials process management, and we’re ready to continue making an impact in this field.
Skore accounts for all of the challenges outlined above and solves them.
Our platform is created to simplify everything by first taking users back to the basics of their process. The first step is to map out how your current process is working. Really take the time to dive in and discover how things are running currently by involving everyone in the team in a process workshop. Doing so enables users to identify bottlenecks: places where things are missing or slowed down and can be improved upon.
While users often find these places during workshops, Skore as a tool will also point these trouble areas out once you input in all additional data. The more information and the more reflective your process maps are of the actual situation, the better for Skore to work its magic.
The entire purpose of our platform is to have all of your processes mapped and documented in one single collaborative place, accessible to your entire team. The existence of process libraries ensures the centralization of all of the relevant information needed to run a clinical trial. Users can re-visit as many times as necessary to make sure they’re following the right steps. They simply have to search for the relevant process on Skore and take a look.
And, because we use Universal Process Notation (UPN), it means that the way of reading the maps is standardised and easily understood. No more confusion or need for a specific individual to be present in order to move on to the next step.
Additionally, our process maps allow users to attach any relevant data without overstuffing the steps. You can add relevant forms or trial or patient information wherever it is needed. This makes the process maps easy to follow and understand for any team member.
If there’s a sub-processes for another step required, Skore also helps visualise it without encumbering the overall map. Instead, you can dive deeper into that particular step to find the sub-process needed by simply clicking on it.
All processes become easy to follow and understand, as the map clearly outlines what should be done next. Each step also has an area for the specific role in charge, ensuring accountability is clear. It clarifies who is in charge of what and when they have to do it, so questions can be brought to the correct individuals.
No more stalling or grinding to a halt when requiring compliance sign-off as it is passed around like a hot potato. It becomes transparent and clear who has to do it, which also helps identify when and why the process might slow down.
With Skore, clinical trial process managers have found themselves gaining back tons of time. Their management processes have become streamlined and a lot more efficient. Clarity becomes the norm and they no longer have to rely on a spreadsheet created by a manager at a different location that is difficult to understand.
Having all the processes existing under one roof and with one simple notation makes everything run smoother, and makes it possible to scale clinical trials even further.
Being in charge of clinical trial management processes is difficult enough as it is.
Skore helps take away any overcomplications that may affect how the trial runs, instead offering clarity and support every step of the way.
The team will be connected and there will be no doubt when it comes to responsibilities.
Are you a clinical trial manager looking to become more efficient?
Get in touch and our team will be happy to guide you!