Develop project management competencies to speed up your clinical trials

The biggest barrier to shortening clinical trial data cycle times is not recruitment.   It is not having a fancy UI for self-service eCRF forms design.   It is not software.

It is not, to paraphrase Medidata, having the ability to Run Your Entire Study On A Unified, Intelligent Platform Built On Life Science’s Largest Database.

It is incompetence in managing a construction project.

That construction project is called designing a clinical trial and the information system for collecting and monitoring data.

For a long time, I thought that this was peculiarly an Israeli problem.

However, conversations with colleagues in the US and Europe suggest that late starts, feet-dragging and time-consuming  change requests may be the norm. Collecting too many variables in the data model is the norm. Complex, long forms that make life hard for the site coordinators is the norm,  Surfeits of edit checks and thousands of queries are the norm.

Most companies spend little  money on project management training and even less money on clinical project strategy development.  Most training is on process, regulatory compliance and standard operating procedures.

Rarely, do we see medical device companies spend money on competencies that will help employees construct clinical trial projects more effectively.

There are verbal commitments that are rarely action commitments.

Yet there is a direct linkage between clinical operations team knowledge and corporate revenue growth which is dependent upon delivering innovative drugs and devices to market.

One way management teams can maximise their investments in project training and clinical project strategy development (outsourced or in-sourced) is to link clinical operations team training to study management competency models that management can qualify and measure.

But the development of a clinical team competency model has strategic and operational barriers that must be managed to make it successful.

Clinical trial project management competency model example

Clinical team Competency Setup Considerations

1. Clinical people often think that building the ‘database’ is an art, not a science, and don’t like to be measured in what they perceive is a non-core skill.

2.  Your project  competency model must include both soft and hard skills training to make it effective.

3. Clinical trial management teams must focus on the competency requirements to make it work and it must be a hands-on approach.

4. You must be able to quantitatively measure the competencies (time to design forms, edit check design, monitoring signals, data cycle time, time spent in meetings, change requests).

5. Competency clinical trial management training programs must be continuous training and educational events, not a one-time event or else the program will fail.

6. The steps of your competency program must be very specific and delineated to make sure it can be delivered and measured.

7. Your clinical operations team must agree that the competencies you are measuring truly help them deliver the study faster (They don’t have to like doing it, just agree that there are required action steps to reduce data cycle times)

8. When implementing your project competencies audits, the certification should be both written and experientially measured to get an accurate reading of the clinical operations team member capabilities.

9. All project  competency certification candidates should have the ability to retest to confirm skills growth.

10. Project competency assessments should never be used solely as a management scorecard tool to make employment decisions about clinical operations team members.

To increase your company revenues and clinical project training success, build and deliver project competency models.

How to annoy your eClinical platform vendor

Every question is a cry to understand the world. There is no such thing as a dumb question.   Carl Sagan

In this guest post, my colleague Tigran Arzumanov asks questions about questions.  Tigran is an experienced and highly talented business developer for life science companies and he’s been around the block a few times.

What to do when a medical device company  asks the wrong questions?

I am sure we’ve all been there.

You meet the senior management of an innovative medtech company. They’re looking for a contract manufacturing partner or a regulatory consultant or an embedded software developer or a clinical research platform. You know you can deliver.  You’ve done dozens of projects like that.

They’re concerned about quality and on-time delivery.     You want to qualify them and make sure they are a good fit for your offering.

You came in on time, you are prepared. You know you can deliver to the client needs. The greeting is welcoming, genuine and heartfelt, the handshakes are firm. Smiles all around. You sit down and start talking. And, little by little, you start finding out what the client wants.

As you hear more and more, your sunny cheerful mood starts dripping away, little by little.

You realize that that the medtech company’s picture of the project and the conclusions that he’s made are drastically different from yours. That the client is likely to reject what you offer, because they want something you do not sell.

Yet, you’ve seen this a dozen times already and you know what the client wants to do won’t work.

What to do

There’s no point in trying to argue your point. Win an argument – lose a client – I learned that this quote by Peter Drucker is as true today as it was in the 80s.

In some cases, you will have to walk away and hope the medical device company realizes soon enough that they are on the wrong track – and once they do, they will remember who gave them a truthful answer.

Whether you close the prospect on that first meeting, or after a year of  conversation, the key is to get to no.   

Getting to no is a great starting point for you to understand the client needs.   Getting to no is also a great way for the client to understand that there are advanced technologies out there that can help him bring his connected medical device to market faster.

A former colleague had a favorite saying – ‘a good vendor answers a client’s question well, a great vendor tells a client what questions they should be asking”.

Carl Sagan was a physicist.  Physicists are curious people by nature. This saying is a great way to make the client curious.

In my experience, most people will ask ‘so, what questions do you think I should be asking?’ Then you are not pushing your vision and ideas, but keep on answering the questions. The client is still in control. And if this phrase has not triggered their curiosity, perhaps you are better off walking.

Another way to mildly give a version different from the one the client asks is to give an anecdote from your experience. Acknowledge what the client has said, and then say “actually, I had a client in a similar situation”. If the flow of the conversation allows it, make a pause so that the client asks how it turned out – and then deliver the story. Few people will resist the temptation to listen to a story about someone in a similar situation to them – and if they pass, perhaps you had no business being in a meeting with them in the first place.

Tigran Arzumanov is an experienced business development/sales consultant running BD as a service, a Contract Sales Organization for Healthcare IT and Clinical development.

 

 

 

 

 

 

 

 

 

Curious about how cloud technologies and AI can help you get your medtech product faster to market?

100X faster to deviation detection in medical device studies.

Automated Patient compliance deviation detection and response on the flaskdata.io platform for a connected medical device clinical trial is 100X faster than manual monitoring. Automated compliance monitoring analytics and real-time alerts let you focus your site monitoring visits on work with the PI and site coordinators to take total ownership and have the right training and tools to meet their patient recruitment and patient compliance goals.

Strong patient adherence in real life starts with strong people management

Hagit.jpg

Patient adherence in real-life starts in clinical trials determining the safety, side effects and efficacy of the intervention, whether a drug or a medical device.

Like any other industry – success in clinical trials is all about the people.

The hugely successful movie – “Hidden figures” tells the story of the gifted black women mathematicians who played key roles in the NASA space program in the Mercury and Apollo space programs. It is a moving, inspiring and (sometimes hilarious) story of how NASA, a dominantly white male organization came to accept diversity during American desegregation.

By comparison, the Israeli life science industry lives in a different time and place and women are in leadership roles at all levels  of Israeli life science companies.

In this 4 part series of articles, we will tell the story of the gifted Israeli women who are the   “Hidden figures” of the Israel biomed/biotech industry.

Women comprise about 65 percent of Israel’s biotechnology workforce, and about 13 percent of top management positions in companies listed on the Tel Aviv Biomed index. In order to find out what attracts Israeli women into this globally male dominated field, I talked to a number of well-respected women, tried to learn about their story, get acquainted with their mindsets and solve the “mystery” of Israeli women invading this field.

Part 1 of the series tells the story of Hagit Nof – former Country Manager of IQVia in Israel and  currently the COO & BD of nRollmed an Israeli startup that helps clinical trial sponsors speed up their study using online patient recruitment and optimization.

(IQVia is the world’s largest provider of biopharmaceutical development and commercial outsourcing services ).

Hagit has a great story of a dream come true for a person who was not afraid to make a risky decision at the right time and was able to build a career in the biopharmaceutical industry literally from scratch.

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Why you do not want to unify data in your medical device clinical trial

Unification of data from patient medical records, hospital reports and clinical trial protocols is a tempting yet extremely dangerous idea.

In this outstanding guest post, security and privacy expert, Veronika Valdova from Arete-Zoe explains why merging medical records, hospital reports, and clinical trial data is a very bad idea.

 Data breaches endanger your clinical trial success

Medical privacy and breaches of personal health information (PHI) has been a hot topic for several years. For the clinical trial industry, the main concerns are decline in recruitment resulting from lack of confidence in data handling and instances of breaches that affect data integrity that adversely affect NDA and MA applications in major markets, which precipitates administrative action taken by national regulators in response to local incidents.

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You can DIY a chair from IKEA. You cannot DIY your medical device clinical trial

Jenya is a co-founder and VP Clinical at Flaskdata.io. Jenya has a masters degree in biotechnology from the Hebrew University and is a doctoral candidate at Tel Aviv in medical science. She is GCP and CRA certified and leads FlaskData.io customer operations with super-human devotion to customer delivery. Jenya has 2 children – Adam and Adel.

DIY is overused

I think the word ‘DIY’-Do It Yourself is one of the most popular words that I hear lately and although I can’t put my finger on it, DIY stars in almost every field imaginable. It starts with planning our vacation on-line without going out to meet a travel agent, knitting warm scarves for the coming winter instead of buying one, decorating an event hall for a party by arranging thousands of flowers in amazing combinations that can be found on-line and furnishing our apartment with furniture that we carried from IKEA and of course built ourselves using their guide and all of it without professional help!

Don’t get me wrong, I have nothing against DIY; I admire people that can do things by themselves and I hope one day I will DIY stuff instead of buying ready-made things from the mall or calling for a decorator to arrange flowers for my special event.

But my question is, can anything be DIY? Or is DIY and online self-service just one more trend that will die out and we will go back to old traditions of using professionals?

I am a Duchenne researcher. As scientists, we believe in the principle of doing thing ourselves and constantly challenging ourselves with new experiments. We also believe in reaching out to the right people for advice and assistance. When we buy ready-made reagents, antibodies and solutions, it’s for only one reason: allow us keep focused on what we need to do, our research! This is my motto and I believe in it. Unfortunately, we can’t do everything by ourselves, but if we find the right people with the best solutions for our needs, we can reach our goals easier, better and faster.

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