A Sneak peek into the mind of a clinical study expert
Building quality relations is highly important for Clinichain. To do so, we need to come to collective and open-minded core values with our employees, but also with the partners and clients we help out with global clinical equipment rentals. Next, to providing clinical equipment service for global studies, it is highly important to stay on top of developments in the clinical trials field. And to do that, we’ve interviewed a global study director of a fast-growing biotech company.
What is your best way for building relationships with sites?
From my point of view, it is impossible to fully outsource relationship management. From my experience, sites appreciate visits by sponsors at their institutes to get more detailed info on the science, the product and the development plan. In many cases, the CRO’s don’t have enough knowledge to explain the science. We do use CRO’s, but for a big part we are in contact with sites ourselves as well. We visit sites during the study at least once. Our company does invest a lot in investigator meetings and advisory meetings to make sure we are on the same page with the sites and the vendors. We do fully outsource the set-up of the investigator meeting to a dedicated event partner.
How do you select your vendors?
First, I determine the requirements of the study (small study with 1-2 countries and a couple of clinical sites, versus a global study). I am open to collaborate with small niche CRO’s in when the study allows this. I have three preferred (global) CRO’s I like to use for all my studies; A CRO with a niche expertise is for us the most interesting. I prefer to have a good experience and close relationship with account management and executives. This assures that my studies are taken seriously and get internal support when required. In any case, with every type of vendor we set up a bidding event to assure you get the best value for your money.
We choose the right vendor, tailored to the specific requirements of the study. It’s very important to have trustful local contacts. We can always outsource experts to the local sites, but prefer local people who know the culture and speak the local language.
What is your vision of setting up a clinical budget?
I have templates from the past that have been validated. These budget templates are from small niche CRO’s and from Top 5 global CRO’s.
We set up a bidding event with a small and large CRO and explore the difference. Every CRO has its own ways of budgeting, making the puzzle and learning from that. In the end, every vendor has the same type of budget cost during their study. Try to gather as much info as possible. I do research on micro-level to explore what the biggest cost drivers are, such as project management and site visits. Negotiate about the hourly rate of the vendors. You can always lower the costs by decreasing a number of resources. To make sure you offer a transparent quote, without unexpected costs during or after the study, set an annual increase. It can be helpful to organize the project budget in a timeline format, considering every single activity or service, which party Is involved related to which charges. In this case, you have a better overview per single service and who is responsible for it.
How can one build the right culture in a clinical department?
This is all about selecting the right people. People need to be entrepreneurial, hands-on, motivated. I prefer to work with people from previous companies or people who have been referred by people I trust. Also, don’t try to make your operations in your department too complex with rigid operational procedures. Too many procedures and discussions often result in study delays. Sometimes we experience that a CRO hides behind procedures, which makes them less flexible. Make sure there is a good mix of people: structured blue people and out of the box thinking yellow personalities. Of course, don’t miss out on the red and green personalities. Read more about this: https://discprofile.com/what-is-disc/overview/
What is your advice on managing a study?
Work with experienced people and understand that you are responsible, even if you’ve outsourced. Be on top of your study and challenge your CRO’s at all time. Ask why they do the things they do and measure them. Make sure you quickly respond to questions by your vendors to avoid delays and expect the same from them (commit on lead times). Make sure you get the overviews you need to oversee and manage. Don’t be afraid to make changes and make changes quickly with team members from the CRO side when a study is running behind.
What is important in data capturing?
Always use EDC, even in case of a small study. This saves our company lots of time. Invest in high-quality technology and don’t go for the lower cost EDC solutions. Decide this together with a clinical data expert and ensure that data is as accessible as possible. Always think about the site perspective when choosing the right system for your type of study. Make sure the reporting system is safe and 100% clear. Don’t forget to make the data management consistent. The best way to achieve this is to have a standard data collection tool that you use for all your studies.
Do you want to learn more about how we deal with these aspects of clinical equipment rentals like ECG, centrifuges, and freezers for global studies? Or are you looking for tablets or mobile phones solutions for your clinical applications? Get in touch!