What is Digital Clinical?
I noticed this term used quite often in my conversations with customers, colleagues and industry analysts in the last couple of years. As is the case with many things in the past, the building blocks of “Digital Clinical” have been in the works for a long time now. At its core, in my opinion, it is all about various technology advances coming together to progress and enhance the clinical research. To name a few, the core technologies/developments include Mobility, Analytics, Social, Cloud Computing, Big Data, Semantic technologies. As mentioned while this is not a comprehensive list, it is a good start to understand how these are being leveraged to improve clinical research and the impact they are having on Heathcare & Life Sciences Industry, Patients and society at-large.
Areas of Focus:
The following are some of the focus areas across the R&D Value Chain being considered as Digital Clinical initiatives by various life sciences companies in the market space:
- Mobile Data Collection in clinical trials, patient reported outcomes and general quality of life data
- Data aggregation from Payer, Provider, Rx, Clinical and other Health Economic & Outcomes Research Data
- Ontology based repositories, Master data management, meta data repositories and text analytics
- Bio-Sensor and other wearable data capture, aggregation & analysis by leveraging cloud computing
- Mining of data from EHR/EMR, Social Media and other data sources
- Leverage OMOP, Sentinel and other such industry initiative outcomes to kick-start Real World Evidence/Real Life Evidence strategies
Business Use Cases being considered:
Some of the use cases being considered are:
- Site selection and Patient Recruitment
- Use wearable Bio-sensors in Clinical Trials
- Adverse Events in Social Media & Safety Surveillance
- Protocol Validation : Inclusion/Exclusion criteria assessment
I hope this gives a high level overview of what Digital Clinical means, some of the technologies influencing and enabling it and practical use cases being considered by the industry to leverage these technologies and provide better quality of life to patients.
It is amazing to see how fast things change, when right technology comes along, picks up the willfully reluctant “legacy” way of doing things and takes them on a ride of their life time. Not too long ago paper based clinical trials was the norm, and still is in some countries. Then came the electronic data capture systems and technology. While that is, people used eCRFs same way as they did paper CRFs. Slowly that started to change with data validation, edit checks etc.
With the cloud revolution came the thought of having clinical data capture/management systems on the cloud and be managed by a third party while pharma companies controlled the protocol and trial design as well as data transformation, analysis and submission management. Off late we are seeing companies being more open to store and share clinical trial data on the cloud. I think the days of ‘Clinical Platforms on The Cloud’ as the norm will soon be a reality. These platforms will not be limited to Clinical Trial Data but will host systems that provide end-to-end clinical research process support capabilities. Not only that, they will also stretch the boundaries further, by accommodating social media, mobile, big data & analytics capabilities.
Future of technology companies that are pioneers in enabling this transformation is going to be interesting and bright with ample opportunities to take the lead and leap to the next orbit.
I was putting together a presentation for a session on “Enterprise Collaboration and Content Management” earlier this week. As part of the exercise I was making a list of point solutions, in each phase of the Life Sciences value chain, that can be developed using SharePoint. This sources for this list are various articles and publications, customer requests, actual applications that I have seen or delivered to customers and last but not the least, from my own brain. I thought of sharing the list here so it could be useful for some of you and might trigger your imagination on leveraging your SharePoint investments.
My intention is neither to say SharePoint will be a sophisticated solution for all the business needs mentioned above nor that this list is exhaustive. I would like to argue that using SharePoint will definitely be an upgrade from age-old manual and/or paper based process which is still the norm in many organizations. For those who are skeptical about SharePoint being compliant with regulatory requirements like 21 CFR Part 11, I want you to know that it can be “Validated”. May be, that is a topic for another blog post in the future.
As always, your comments and feedback are welcome.
I have been in the IT Industry for over 13 years now. I started my career as a developer. At that time, all that I cared about was whether I remember the right syntax to ensure that all the programs I code, compile right and execute without crashing. After that it was time for me to build products and solutions that solve business problems, thus started my journey into verticals / LOBs.
While I understand the need for some functional knowledge for developers, testers and other members of an IT team that would eventually be responsible for successful development, testing and deployment of an IT solution for a specific functional requirement, I happened to think that the degree of knowledge required varies. In my career as a developer I have changed verticals at least 5 times in the span of 7 years. Even with in a vertical, as you can imagine, there would be multiple functional areas. So, for example if you are working as an IT consultant in Life Sciences industry, the functional areas covered would range from R&D to Manufacturing & Supply Chain to Sales & Marketing. So, even if you try to restrict or focus in a specific vertical, it would still be hard for IT staff to be able to know it all across multiple functional areas.
So, my point is, when it comes to the expectations of various stakeholders responsible for an IT project, ideally you would want all the members of your IT team understand the functional nuances extremely well. However, that would hardly be the case. Hence you should be prepared for some learning curve for these teams. In this world of multitasking, parallel processing and maximum reuse, while it is reasonable to expect an IT specialist to be also an expert in his or her chosen domain / vertical it would not e practical and just.
So, what should one expect?
In my opinion:
1) You need Subject Matter Expert(s) (SME), be it a Business Analyst or a Product Manager, you need at least one person in the team that would act as a bridge between the business and IT teams.
2) You would also need at least one technology person with very good functional/domain knowledge. This person could be a Technical Architect / Lead or another role. He/She should be able to translate the functional requirements to technical specifications.
3) There should be an “on-boarding” process for the rest of the team, that would ensure appropriate functional training as per the training requirements identified as part of project planning.
So, in essence, while the stakeholders would long for IT teams with absolute knowledge of the functional areas, that is hardly the case. As long as there is reasonable planning and effort to ensure the teams are equipped with enough knowledge to build, test and deliver an IT system that meets the requirements of the business, AS A TEAM, one should be content with employing the services of teams that are more technology focused and either have the functional knowledge or imparted the knowledge as part of “on-boarding”.
As always, feedback and comments are welcome.