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Risk Management in Clinical Trials

Geetanjali Bhat
 
Author: Geetanjali Bhat, PMP

The success of a process or a project depends on how well it is planned, organized, implemented and managed. Project managers in clinical study operations take on many challenges including multiple stakeholders, budget control and stringent quality and regulatory requirements. This event’s key note speaker Ms Gessami Sanchez Olle who brings along her tremendous knowledge and experience gave us a very interesting session of Clinical Trials in Project Management.

ClinicalTrials1

Clinical trials are highly complex enterprises that demand professional management at every stage and level. Utilization of the project management methodologies along with the conventional techniques would increase the chances of execution of clinical trials in a cost and resource effective, and time-efficient manner.

Although my background is not in pharma and I do not have much knowledge on clinical trials, I was glad to attend this event because I could gain great insights on how risk management can be applied to clinical trials.

The night began with a definition of “clinical trial” as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. We then went through the process of discovery to commercialization of clinical trials.  

Phase I to Phase IV is a complex journey of a clinical trial. The journey to Phase IV involves the internal and external stakeholders.

Project management becomes more complex due to known risks (known-unknown) and unknown risks (unknown-unknown/unforeseeable risks). In the pharma industry there are added uncertainties from the process of scientific research.

ClinicalTrials2

The PMBOK defines risk management as the identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks.

The application of risk management in a clinical trial is implemented through the process of risk management from the identification of a risk to its monitoring.

Risk management has immense impact on the success of a project, along with risk-based monitoring methodologies (RBM) that can be applied in a clinical trial that include centralized off-site and adaptive on-site. RBM is a clinical trial-monitoring technique that fulfills regulatory requirements but moves away from 100% source data verification (SDV) of patient data.

At the end of the session, we learned how Phase Study I, Phase Study III and Phase Study IV were conducted for a clinical trial along with the challenges that are faced therein.

along with other applications can go a hand in hand to

project management in clinical research

along with other applications can go a hand in hand to

I would like to summarize that project management along with other applications go hand in hand to enhance the process of clinical trials. Risk management can be applied well in the processes mentioned in the PMBOK for clinical trials to achieve most of its success factors.

Newsletter Editorial June/July 2019

 

 

 

Adi Muslic 100x100

 

 

 

 

Author: Adi Muslic, PMP

 
 
Summer is here!
 

Last week was an extremely hot week and I hope you did not need to be outside for a long time. However, if you indeed had to do your work outside I would be happy to hear from you how did you manage to work in such hard conditions. Actually I am not sure how many of PMI membres in Switzerland actually work in sectors where working outside is a standard working environment. Would be nice to hear their stories.

 
Lat week I was working in Geneva's city center. Besides many people that were dressed very light there were those who were fully dressed up, so a full suit and a tie. Yes, they were people working in the private banks and there are many of them in Geneva. A traditional banker's uniform. Every day we are hearing a lot about digital transformation; the standard banking model is more and more challenged by fin-tech and online banks. It made me wonder whether there was the time to change the dress code in the banks.
 
There was time when taxi drivers were wearing suits and ties. Today, anyone hardly cares whether the taxi driver has a suit or not. But what I think we all care about is whether the car is clean or not. This is why I appreciate the digital model where you can easily leave a note or a comment. In the standard taxi car model I am not even sure what is the way to report someone who provides a bad service.
And there is also a world of private limousines with a very strict dress code, not to mention state of the car. 
 
Going back to the banking world, does the dress code and business model make standard banks look like taxis and private banks like private limousines. Using this comparison it is clear that there is a place for fully digital banks. Whether all 3 business models will all survive or not, we will need to wait and see.
 
This reminds me of another sector where the dress code is important. The car sales. Looking forward to see how this sector will change with digital transformation. Have you been already engaged in such transformation? Please share, this is the right place.
 
Wish you a beautiful and not so hot summer,
Adi

Event article: PM Master Class: SCRUM Master & Agile Training

Author/Interviewer: Elena Milusheva, PMPElena Milusheva

 

Scrum and Agile - from theory to practice

Agile might not be the end of the journey, as the new global PMI CEO Sunil 

Prashara has stated, yet not every company reaps the full benefits of agile. Many haven’t even jumped on the agile bandwagon yet. The 2-day PMI Master Class organized by the Swiss chapter in May in Zurich showcased how different industries leverage agile and scrum.  

As we have learned from our trainer - the first PMI-ACP certification holder in Switzerland Silvana Wasitowa - failing (fast) is encouraged, multitasking is not optimal and line managers step back giving space to self-organized teams. And it is not about the daily stand-up meetings, it is not about the frequent delivery. It is all about the agile mindset. 

In order to obtain insights from the field, I am approaching 3 PMI Swiss Chapter members of the leadership team who are also PMI-ACP certification holders with the following questions:

How different is Agile from the traditional Project Management? 

Larisa Aragon: Agile can easily be integrated in a highly flexible Project Management Methodology. I have experienced and being trained in the Hermes 5.1 Project Management Methodology developed by the Swiss government. Agile is another important tool and skillsets (incl mindset)  to approach the rolling planning in a different way. 

Loic Hascher: The whole philosophy behind Agile is the implementation of short iteration cycle. Instead of trying to deliver the full scope in once through a planning stage, followed by an implementation stage and finally a closing phase, Agile cuts the overall scope to deliver it small piece after small piece. 

David Fowler: There is no such thing as “traditional” Project Management. Projects are, by definition, unique. There are many ways to approach the management of a project and many techniques and frameworks available to support the project manager. Agile should be an integral part of that project management toolkit, which can be utilised when and where appropriate.

How do you practice Agile mindset?

Larisa Aragon: I like to think about the role of the project manager as a sports (agile) coach, empowering the players to take the best decisions according to their knowledge and experience, trust their abilities, ask the right questions and have fun together.

Loic Hascher: For me, being Agile means being open to change. We use to be trained to control changes. That changes can kill your project and that they need to be planned, assessed, evaluated, etc… But we also know that changes are inevitable in the fast paced world we are living in. Agile is all about welcoming changes and integrating them as part of the project while still being able to deliver value to the end customer.

David Fowler: Keep an open mind. Reflect on how you are delivering your project and if you are using the right approach to achieve the end goal:  smarter, more flexible project management, embracing change and delivering business benefits earlier to your customer.

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Depending on where you stand in your career, you might want to deep dive into the topic by acquiring some of the following certifications. Please do not hesitate to share your experience with scrum, agile and with the certifications below via This email address is being protected from spambots. You need JavaScript enabled to view it. 

Webinar "Meet the Swiss Volunteering Community"

 

Diana Lagalante PMI CH 2019jpeg

Author: Diana Lagalante

The PMI Swiss team launched the first "Meet the Swiss PMI community webinar" on May 16th to engage in an interactive way with all members through a Q&A session and to instruct on the many benefits of being a member at PMI.
Stay tuned, we are preparing for the next LIVE webinar on Social Media Engagement with the SM&Marketing Team.

Editorial April 2019 Newsletter

Carlos Martinez Arteaga 100x100

Author: Carlos Martinez Arteaga, PMP

Dear members and newsletter subscribers,

"A man who dares to waste one hour of time has not discovered the value of life" - Charles Darwin.

I turned 41 not long ago, and it was not until about now that I have started to think how precious time is. I have always liked being on time, taking time to do things correctly, and taking time to do nothing, but now it is all different, time has become very important for me, and I am very conscious about it.

In the end I suppose all sayings are really there because they contain a truth, for this case at this stage of my life "Time is Gold".

I have mentioned also in the past that I am the father of 3 kids aged all below 7, and for those who are in the same boat and can relate, then you know how time can fly away without having done anything. As a father of 3, I try being more efficient so that everything takes less time to get done, this requires concentration and being constantly on.

For me time, from not even thinking about it at all has become a weighting scale, where I value what is worth doing and when, this has helped me to prioritize and to avoid rework, as I am only engaged in that which is important at that point of time and that I know is ready to be done.

Being conscious of time, and knowing that it is now or never, has helped me to take a step forward and make decisions in a way that I can take control on my path. For example in the past I might have thought that I could attend an event next time, now I evaluate if it is worth going at all, and if it is and there is nothing else burning, I do it.

It sometime comes to my head a movie in which time becomes a currency and the rich are those who have the most and the poor are those who struggle to now if they will be able to see the sunrise, in a way I now see it like that.

At work, I am sure you have been in the position where there is always someone who robs our time. It is important to create relationships at work, thinking if they are genuine or not, and how we can get the most out of that relationship, in the case of relationships that we know are none existent and that any effort in it, I think that not without being polite, that the time spent on these should be minimized.

Then when in a team, we should identify who is robing the team’s time, these people should be immediately shut them down, assigning them an specific task which they have to complete, therefore keeping them busy, and avoiding that they lose the focus and the team’s focus.

Going back to our personal life, invest time with those which matter and genuinely care for you, doing what you and they most like, no matter what, always find time for things that make you feel happy to be alive.

Time is the coin that you will pay with, and that I am sure they will treasure when they realize that there is no more valuable currency than time.

"You may delay, but time will not" - Benjamin Franklin.

Take it easy,

Carlos