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Topics: Agile, Healthcare, Portfolio Management
Clinical Trial Management using Agile Methodologies

My role as Project Portfolio Manager for my organization is to lead a diverse team spanning multiple departments through the process of starting up clinical trials. We have 4 trials in the pipeline along with 6 others that are already in active management. While the work spans different trials, the timelines clearly overlap each other. This results in resource capacity and prioritization challenges.

I recently watched the webinar by Kelly Weyrauch on "Backlogs and Burndowns: An Alternative to Gantt Charts for Planning Product Development Projects" (

I became intrigued on the possibility to introduce this methodology in an environment that's waterfall heavy. I'm curious to know if others saw success in introducing agile concepts, tools, and processes in the clinical research environment. If so, how did you do it? What challenges did you face? What key lessons learned can you share?

Thanks in advance!
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I am using them right now with waterfall life cycle process. It works. The problem with Gantt Charts is that, except for some projects with sequential life cycle (take into account that people is confused and call waterfall to sequential. Waterfall has iterations) things does not happen in the way Gantt Chart shows. In my case, to maintain compliance with our governance requirements, I created the method we use in my actual work place implementing Burndowns with MS Project schedule. In the case of backlogs we use it from long time ago but this is about product features. Just to clarify: those are techniques not methdodologies. That is the reason because you can use Agile with any type of life cycle model and process. You can use techniques to apply Agile to your process. Agile is not a method, is not software related, is not a life cycle, did not start with the Manifesto. Just to add something more we use Agile to create software and non software products (for example we use Agile to create a new line of biscuits that is a success in the market).

I would be interested in that also, hopefully someone will reply to that question Amit.

Amit -

Specific agile practices such as prioritizing work in a backlog or organizing work into sprints could be applied to different types of projects but a challenge with getting the benefits of agile delivery approaches in the clinical research domain would be the progressive phase-based approach and heavy documentation required to meet regulatory requirements.

Would definitely like to learn about which practices can be applied "as is", which are not suited and which needed some adaptation...


The primary preconditions for Agile execution are as below:
1. Always available product owner;
2. Stable, mature, disciplined project team with focus on deliverables;
3. Cross-functional skills in team;
4. Team and product owner empowered to take decisions on outcome and plan;
5. Management support for Agile approach
6. Accepting cone of uncertainty

If these preconditions can be met, there is no reason why an Agile approach cannot work for your projects.

But the question needs to be asked whether the shift to Agile is really needed. Are we doing this because Agile is the new buzzword? Can we quantify the value received from Agile?

The time cost and quality cost of shifting a team over from waterfall to Agile is not usually compensated by the value received in the deliverables.

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