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Automation in Regulatory Affairs : 5 essential criteria for process selection

In the last month at least 3 clients (top 10 Pharma) that I spoke to brought up Automation in the context of Regulatory Affairs. While it is very common for everyone to get excited about some of the popular technology trends and jump on the bandwagon to adopt these within a business context, many such initiatives fail to find traction and success unless they are carefully managed with a strategy and plan.

Regulatory Affairs function is not immune to this temptation. However, the excitement is typically tampered by the implications of things not working out resulting in regulatory compliance issues and product approvals. However, many activities within Regulatory Operations are repetitive in nature and are very conducive to being considered for automation. In my opinion, the criteria that should be considered while assessing a business process for automation are:

  1. Process Type: Nature of the Business Process in terms of Strategic vs. Tactical
  2. Frequency: How frequently is the process invoked to deliver business value
  3. Manual Tasks: How many tasks within a process are manual in nature and are leading to process inefficiencies and errors
  4. Benefit: How much hard/soft benefit can be delivered by automating the tasks
  5. Performance: Can the steps be measured easily to assess the performance

Assessment & Prioritization:

To create a strategic plan for automation, each process in Regulatory Affairs ranging from Regulatory Strategy to Life Cycle Maintenance can be assessed based on these criteria. RA-Automation-Criteria

Prioritization of the processes and/or tasks within a process can be done by arriving at a balanced scorecard for automation. The weightages provided in the chart can be used as reference but can always be tailored based on any given organizations’ needs and inputs. The criteria can also be leveraged at the enterprise level to assess other functional areas like Clinical and Safety, in order to prioritize at the department level to assign and approve budgets. The key is a structured way of identifying opportunities, assessing them for automation ability and prioritizing based on balanced scorecard. RA-Balanced-Scorecard

The above score card does not cover all the processes of the Regulatory Affairs processes. However, it is used to illustrate how to create a balanced score card to prioritize the processes for automation.

While organizations are considering moving to a Regulatory Information Management platform of the future, they can still consider automation as a way to compliment process improvements achieved. In fact, I strongly recommend creating an ‘Automation’ workstream as part of the RIM initiative so that all the work done to harmonize the processes and transform the processes in preparation for new platform adoption can be harnessed to assess and prioritize the processes for automation with minimal impact to ongoing work.

In a subsequent post, I will look at the processes within Regulatory Affairs that can be prioritized over others, based on my experience. I will also look at potential use cases within each process.

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Patient Participation in Clinical Trials Infographic

Another “Eye Opener” of an infographic from Lily COI team. The data presented seems to indicate that 10% of the patients do not participate in the clinical trials. If only they saw the infographic published by this team in Decemeber that the patients on Placebo will also receieve the standard treatment, could they be swayed to join the trial? Interesting question, Isn’t it?

Lilly Clinical Open Innovation

In December, we published our first infographic. Our goal was to start a discussion around the question: “How often do patients receive placebos in cancer clinical trials?” After digging into the data from cancer trials registered on ClinicalTrials.gov, we found less than a 1 percent chance of a patient receiving a placebo alone on a cancer study. The majority of placebo-based trials adminster the placebo along with standard of care treatments. 

We received some great constructive feedback on the graphic from the patient advocacy and clinical research communities through our blog and Twitter. We appreciate those who asked clarifying questions and gave us suggestions for future infographics. Armed with their input, we went to work on our second infographic.

ppct-R1.1

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Placebos in Cancer Clinical Research: An Infographic

While Placebos have been in use in Clinical Trials for a long time, I always wondered about the fate of patients who would receive a Placebo rather than the actual drug. This Inforgraphic by Lilly COI team provided an insight into Cancer Clinical Research and the use of Placebos. Thought I’d share it. Personally, I feel we ought to leverage newer technology like Human Genomes and perform more targeted research to not only reduce the cost of clinical research but more importantly reduce the impact of a critically ill patient receiving a Placebo instead of teh actual treatment.

Lilly Clinical Open Innovation

Back in September, we spent some time looking into the overall use of infographics in the clinical research space for a blog post titled, “Using Infographics to Increase Understanding of Clinical Trials.” What we learned is that there is  a real opportunity to create more infographics that present information about clinical trials in a way that’s clear, concise and visually-appealing, and that helps answer some of patients’ most frequently asked questions.

So, we decided to take a stab at putting together an infographic of our own. The question we set out to answer: “How often do patients receive placebos in cancer clinical trials?”

lilly, placebo, clinical trials, cancer, infographic, medical research

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2013 in review

The WordPress.com stats helper monkeys prepared a 2013 annual report for this blog.

Here’s an excerpt:

A New York City subway train holds 1,200 people. This blog was viewed about 4,300 times in 2013. If it were a NYC subway train, it would take about 4 trips to carry that many people.

Click here to see the complete report.

I wish…I wish…

I have had enough blabbering from the NY Jets and I wish the Pats cut them to size this weekend. I agree they have a good defense but they talk too much and their offense stinks. I liked what I saw in Patriots against Bengals last week. Both their defense and offense did very well against a 2009 playoff team that is predicted to reach playoffs this year too.

So, hopefully I don’t have to hear about the Revis Island, No. 1 defense, Super Bowl so on and so forth from the Jets again next week.

Let’s go Pats!!!

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