Important Tips for a Successful CTMS and eTMF Implementation
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Important Tips for a Successful CTMS and eTMF Implementation

Implementation of an advanced CTMS, eTMF and eClinical platform can bring huge benefits to a business. The FDA has adopted digital submission requirements and the Sponsors and CRO’s we work with have all seen the benefits of “going digital”, or they wouldn’t have contracted with SureClinical for their CTMS, eTMF or eClinical Platform. They are well aware of the time, cost and quality issues of relying on paper processes and spreadsheets. However, in my role working directly with customers to maximize the value of their eClinical implementation, I’ve found many of them leave money on the table in the form of process efficiencies when moving to a digital platform.  In helping many companies make that transition over the years, I’ve developed a playbook to help maximize the value of an eClinical implementation. 

Understanding what you've just bought, aka System Capabilities

Many go into an implementation sure that they know the system will bring them a myriad of benefits and process efficiencies, but most of your users will be unsure of what that really looks like in the system. It’s important to take the time during the periods between decision and project kick-off to make sure the project team and users understand exactly what the system is for, as well as the internal challenges it is being implemented to solve.

It is important to understand the full capabilities of the platform you are adopting. While you may have made a purchasing decision based on an ROI to solve a specific problem, there is often a wide range of functionality that can be overlooked that can bring even faster ROI to your enterprise. In our case, one of the best examples we have at SureClinical is the use of our FDA and EC-compliant SureEsign capabilities.  Clinical and Quality may have pushed for the solution as it meets very specific Clinical Operations compliance needs, but once IT determined the benefits to the company as a whole by adopting digital signing for all contracts and agreements, benefits multiply. 

In short, understanding the full capabilities of what you are buying can see huge improvements downstream.  Your vendor account manager and support team are there to make sure you maximize the value of your implementation.  Use them! 

Internal Alignment

Preparation, Preparation, Preparation. We all know it’s important, but what does it actually look like in practice? 

After you understand what the capabilities of the system are, ask yourself who else needs to know. Work out a clear communication, training and rollout plan and make sure the person leading the implementation is a great communicator. It’s amazing how many projects suffer due to poor communication.  That is a solvable problem if there ever was one. To communicate well, you need to know…

Who is going to be involved?

A common stumbling block with system implementations is to have part of the project team familiar with the system, but bring in users later down the line who come with no understanding of the system, and only a basic grasp of the overall project itself. It is important to take the time to really think about who your users are going to be and how, when, and in what context they will be using the system. There will always be obvious power users, but make sure you’ve thought hard about everybody you would like to be involved from the start. If you’re a CRO, do you want Sponsors to have access? How about certain site personnel? Once you have everyone up to speed, decisions are made much faster and with much more long term benefit when the right people are involved from the start.

A digital handshake

The ROI magic happens at the intersection of people, processes and technology

What Challenges are you Solving?

It is important to nail down the key challenges you are solving with the implementation. Is it adding Electronic Signature capabilities? Is it eliminating the manual workload within your TMF process? Managing complex project timelines with CTMS? Are you looking to change the lives of your monitors by giving them powerful automation and a tablet to complete all their tasks at site?

With all these questions, it’s important to realise the best goal is a combination of your processes with the system. What are the system’s real strengths? What essentials do you need in your processes? When you build the 2 together you get the most powerful outcome for your business. 

For example, if your system has supreme flexibility on mobile devices, why not design a new monitoring visit process around being able to capture data at the site?

Update your Processes and Technology Together

Probably the best advice I can provide is to look long and hard at your internal processes before starting your implementation.  Some may be mandatory due to internal and/or regulatory requirements, while some were likely developed due to the constraints of a legacy and/or paper system you were working with.  Before optimizing for a process that has run its course, it’s worth taking a look at all the capabilities of your new system and determining if you need to update some processes as well to take full advantage of the benefits of your new system.  

For example, one of our customers told us that they used to manage documents and signatures through email before implementing SureClinical.  Once they started testing out SureEsign and SurePortal where all they have to do is send an invitation link to prospective sites to complete their tasks and document submission, they realized the huge time, cost and mail server backlog benefits, and made a process change to mandate using the portal for all study startup document submissions. Warning:  this will likely not come as a surprise, but not everyone loves change. Your own change management professionals can manage naysayers, but it’s been my experience that if you can articulate the benefits and make the change as easy as possible through communication and training, you’re 90% of the way there.

Letter tiles that spell the word Chance

Take a Practical, Hands-on Approach

It’s important during the implementation to make sure you and your key users are in the system and have regular access to assess any changes, before the testing, training and validation go ahead. 

One of the benefits of a Cloud-Based system is the enormously reduced validation burden, having the IQ and OQ done by the vendor, coupled with only configuration level changes makes testing and validation so much easier. 

With your key users experts in the system already, any tweaks to scripts and training are that much easier to make. Coupled with the combined nature of system and process improvements together, the final picture is much clearer, due to the work you have done in the steps above.

Conclusion

In my experience, the most successful implementations are those that have started thinking about the final picture early. Those customers are prepared, they have a good idea of what they want to gain, and are open to talking through those ideas and change their approach if there are better ways suggested by the vendor.

Everyone has a return on investment (ROI) goal.  After all, you likely wouldn’t have decided to implement an eClinical solution if you didn’t expect a good ROI.  By identifying your key users, mapping their critical processes to key functionalities, and in parallel to leverage the full power of what you have bought. 

Finally with strong internal alignment, to paraphrase, happy users, happy life!

 

 

Simon Taylor

About the Author

Simon Taylor began his career in pharma at Gilead, managing day-to-day Trial Master File (TMF) operations and site management activities, seeing multiple drugs from Clinical Trial Application (CTA) through New Drug Application (NDA) approval. Since then, he has turned his attention to clinical technology and leads SureClinical’s customer-facing product offerings.

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