Jenya wrote a piece about the challenges of clinical trials operations change management for regulatory people who have to work with medical technology developers and I just had to write my own intro.

Frankly, its easier to talk about change for other people than for yourself. A lot easier.  I have written here, here and here about the gaps between the stakeholders in medical device clinical trials – security, IT, engineering, product marketing ,regulatory affairs and medical device security to name a few.

Overlook change management at your own risk

Change management is a topic usually overlooked when medtech companies implement cloud EDC, and introduce medical IoT for collecting data from patients directly and use electronic source documents for their connected device/mobile medical app or device clinical trial.

In this post, Jenya talks about how to manage change during the transition from traditional medical device clinical trial data management to cloud technologies, remote monitoring, medical IoT and electronic source data.

So enjoy.

Danny

Vintage process vs. Innovative technology

There is a divide between the hi-tech mindset of medtech developers who live in a world of devops, agile development, medical IoT and APIs and their regulatory / clinical operations colleagues / CRO  who are living in a heavily regulated world of processes relying largely on paper, SDV and manual monitoring of data with site visits.

If you want to bridge this divide, you need to manage change for the people you work with.

Paper and manual processing was state of the art in the 80s.

There are great technologies for ePRO, medical IoT and eSource in medical device clinical trials but they cannot be implemented without proper change management.

We note that most of the EDC vendors pride themselves on designing systems for self-service forms design that will make an ECRF look like a paper CRF.

This might have made sense 10 years ago, but that is not the way an online user experience is designed – by making an online experience look like paper forms.   You use Facebook and LinkedIn – you know better.

In essence, this approach perpetuates a paper-based mindset and makes change management for adopting new novel information technologies more difficult.

Let’s challenge this first assumption – Why should digital flow be the same as paper flow?

Source documents – the holy grail – are still mostly paper

The vast majority of Cloud EDC implementations involve sites entering data on paper and then transcribing it into an online Web application instead of capturing the data directly into an online form because they need to reference a source document – in most cases a paper source document.

This is not a given and it is certainly not the way a connected medical device vendor wants to do business – collected electronic source data directly from patients via medical IoT.

In fact, airline reservations agents have been working directly online since the late 70s using the famous IBM Sabre and IPARS systems.

So – there is no real technology barrier to electronic source. Perhaps the first barrier is mostly mental.

A trend (which is growing slowly and hopefully surely) is to adopt eSD – electronic source data capture Using a ultrabook, tablet or smart phone – the idea is to capture the data at source in the hospital (or at home) directly in a digital format.

Using eSD – electronic source documents in your next trial is both an opportunity and a challenge. While most patient records are electronic, and sites have reliable Internet connection, many sponsors have yet to implement eSource to EDC integrations. Why is this the case ?

The 5 eSource implementation hurdles

1. Data collected – should not trigger an FDA audit. Use of home-grown on-line forms systems is a particular concern, especially when the forms application is developed by a programmer who does not have previous experience with regulatory systems and compliance requirements.

2. Adopting a new way of doing things – using tablets (for example) to collect source data electronically should speed up data entry time, improve site compliance and improve data quality but if the interface to the EDC is not well-built and validated – it may actually be a curse in the guise of a blessing.

3. Use of electronic source documents will require user training, IT support (which you didn’t need for a cloud-based Web application) and modifications of SOPs for data entry and discrepancy management.

For the CRO – eSD is a double-edged sword with potential loss of revenue for CROs because of reduced SDV if eSource is used

4. Lack of clarity over who retains control of storing the clinical data. Is it the eSD system and its interfaces to EDC or is it the data management team?

5. While eSource may be a challenge for the sponsor and their CRO, in fact for sites and site coordinators,eSource is preferable for 3 very important reasons:

eSource eliminates paper-to-EDC transcription and all the ensuing time and issues involved with holding a piece of paper and doing data entry into a web form

eSource features faster, friendlier and easier-to-use user interfaces including great features like capturing pictures, voice annotations and hand-written notes using tablets can be productivity tools for hard-working medical staff.

eSource eliminates the costly physical storage requirements of paper source

A 5 step plan to manage change from paper to digital

1. Step 1 – Change your mindset from paper to digital. You have a late-model smart phone. You can have a late-model EDC system too.

2. Step 2 – Do not develop the software yourself. The technology development, support and regulatory challenges of validating and supporting home-grown software is unreasonable. Talk and listen to vendors.

3. Step 3 – Get clarity on your objectives for the technology. Hone in on the data quality and monitoring metrics you are looking for. Define the online alerts and monitoring dashboards that you’d like to see in your study and talk to vendors – ask them tough question about how you will get the alerts and dashboards without a major software development project.

4. Step 4 – Clarify one-stop ownership of the database with your cloud EDC vendor

5. Step 5 – Do a risk analysis and consider 21 CFR Part 11 issues up front. Your decision to validate your software systems, and the extent of the validation should take into account the impact the systems have on your ability to meet predicate rule requirements.Base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity. For instance, validation would not be important for a word processor used only to generate SOPs.

In conclusion

EDC systems are a commodity today whether you use Medidata or ClinCapture or Oracle.

Electronic source data capture and using medical IoT to capture data directly from patients is an important step in paper reduction and data quality improvement.

Use of modern technologies is a recommendation by the FDA and there is no tangible reason (beyond entrenched mindsets) to be deterred from adopting new application technology that can eliminate paper storage, improve data and above all make the job for sites much faster and easier.
Manage the change management process with a justified and documented risk assessment

Contact us for a free phone consultation on adopting eSD and medical IoT into your next trials, risk assessments and change management across the paper-digital divide.