2 March 2016

The Importance of the Data Does Not Change – Interview with KCR’s Head of BMX

“The Importance of the Data Does Not Change” – Interview with Joette Keen, KCR’s Head of Biometrics and Clinical Trial Data Execution Systems (BMX)

Berlin – 02 March 2016 – Joette Keen talks about her transition to CRO, after spending years in pharma, and how does she see data management role in the ever-changing clinical trials world.

You have spent many years in one of the biggest pharma companies. What encouraged you to move to the Contract Research Organization (CRO) industry?

Joette Keen (JK): Sometimes an opportunity in life appears when you least expect it!  I had a lengthy and fulfilling career and planned to retire, but then I had a chance to join a CRO. I had so much experience in the clinical trial business, and it just felt wrong to not continue to use what I’ve learned over the years to help further evolve and shape the way we work in this important industry.

I thought it would be very interesting to see the work from a different angle – not on the sponsor side, but from the CRO side. As a sponsor, we always asked CROs to bring the “best and novel” ideas to the table based on innovative thinking, as well as what they have learned from working across many sponsors and trials. I was really curious to see what knowledge was out there and how it was being harvested by CROs and used to improve how we do clinical trial business.

How do you see the role of Data Management in today’s clinical research world with ever-shifting requirements of clinical trials?

JK: Anyone who knows me, will agree I always speak about the importance of “the data”. Requirements may shift – but the importance of the data doesn’t change! Without quality data, it doesn’t matter how good everything else has been done. 

So I see the role of Data Management in two dimensions. First, use the electronic data to examine performance by sites: where are the problems, what and how do we work with our field personnel to address those quickly and effectively?  Be sure you have mechanisms in place to take full advantage of the data in our systems. This ties in nicely to the concept of risk based monitoring as well. Secondly, strive for lean processes and the most resource efficient ways to ensure the quality of the final data product. In this highly regulated industry we are always talking about time and cost while adhering to high regulatory standards. There is so much competitive pressure on Pharma to be first to market, while there is also pressure to manage the cost of the new drugs being delivered. 

Data Management in the CRO industry plays an important role as a partner in being able to consider the two dimensions – study performance and data delivery in order to help sponsor’s achieve their goals.

How important is the software you choose for providing high quality and time accurate results?

JK: There are several great products for EDC on the market.  Of course the ability to easily and intuitively design the system and edit checks is important to meet the demand for fast study startups. From there the next important aspect is to have traceable validation to your requirements that can be proven according to your test plan. Once a trial is in production, data review personnel need to be able to quickly identify work – new data, changed data, responses to queries raised about data. As patients are enrolled, they are typically randomized to a particular treatment regimen; however, how this is accomplished can greatly vary.

During the study conduct, most trials collect data that require some type of “encoding” in order to meaningfully combine like information for analysis.  Depending on the type, size and other factors there can also be various types of data that comes from external sources, generally referred to as “vendor data”, and can include things like laboratory results, specialized measures like ECGs, etc. which have to be merged with the EDC collected data. 

As the data is reviewed it is important to have the ability to close out completed data and lock a visit, a patient, a site or a data base; this is the last fundamental capability of the software. Most EDC software, including that selected for use by KCR, accounts for some if not all of the capabilities described. So what differentiates one from another in my view is how well integrated these other capabilities are with the base EDC product and is there flexibility in how the tool manages these integrations. Another differentiator is cost.

Can you describe the tool used by KCR?

The product selected by KCR, Clincase developed by Quadratek, has all the features to manage the work efficiently, including having seamlessly integrated the encoding tool, laboratory uploads as well as the IWRS randomization and the drug inventory and management process features. The full EDC solution is offered at an attractive cost, so it is affordable for the smaller and mid-sized companies who work with us, while meeting the needs of any size sponsor. I think these factors about the tool allow KCR to do an outstanding quality job, meeting all of clients’ needs, while keeping trial costs manageable.

What aspects of your current role would you see as the most demanding?

JK: When asked this type of question, the first inclination is to think about work.  But in truth, the most demanding aspect is to balance leadership in getting the work done while finding the important time to be a coach and mentor to my team. One of the real passions I have about working is to “give back” from my life long experience and draw upon my interest in human psychology. I work to create an environment where people can be courageous, candid, empowered and engaged because when we operate in that spirit everyone’s ideas are considered and we all grow and learn.  Fostering that behavior, both within my team and across teams with whom my team interacts, is something I find extremely important as a “culture” for BMX and KCR. 

What would be your team challenge for 2016? What are your nearest plans for development?

JK: My biggest challenge is to continue to grow BMX and raise awareness about the excellent services the team here at KCR can deliver. We can operate as a full service team alongside our ClinOps colleagues, or offer either or both Data Management and Biostatistic services to a client as stand-alone services.  Since KCR was so well established as a Clinical Operations CRO, having sponsors understand more about our team and what we offer is very important to the vision within KCR and our leadership team. 

To that end, we are continuing to engage in sharing some of the interesting knowledge and experience my team offers. Not just in doing the work, but in how deeply they understand the direction of this Clinical Trial business and their forward thinking and passionate desires to excel. We continue to seek talented individuals to join our team and welcome ideas we gain from our exposures to others in the industry. 

The BMX team at KCR works remotely from different European locations, however, we definitely take advantage of our overlapping time for meetings and discussions. Being US-based I see that we all are influenced by our culture’s behavioral norms. As a benefit we can draw upon our own individual yet diverse insight, which allows us to think about how sponsors in different regions approach business and therefore prepare messaging and consider responses according to those sponsor’s expectations. 

On the technical side, we continue to adopt new and efficient approaches to business needs. For example, we have an internally developed CTMS system that we continue to evolve.  My team also has championed and introduced the use of an electronic trial master file last year, and we continue to evolve the governance around both of these systems to ensure we maximize the value for the organization and our clients.

About KCR
KCR is a Contract Research Organization (CRO) providing strategic clinical development solutions for the pharmaceutical, biotechnology and medical device industries in Europe, Israel and the U.S. More than 300 professionals support clients with full-service capabilities across our three main service areas: Trial Execution (TE), Functional Service Provision (FS) and Late Phase (LP). Focusing on knowledge, quality and innovation, KCR delivers high value solutions customized to clients' needs. Headquartered in Berlin, Germany, KCR operates across 19 countries in Europe as well as the U.S. For more information, visit www.kcrcro.com.

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