What is your best way of 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 information on the science, the product, and the development plan. In many cases, the CROs don’t have enough knowledge to explain the science. We do use CROs, but for the most part, we are also in contact with sites.
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. In addition, we fully outsource the set-up of the investigator meeting to a dedicated event partner.
How do you select your vendors?
First, I assess the study requirements, whether it’s a small-scale study involving 1-2 countries with a few clinical sites or a more extensive global study. When the study allows it, I’m open to collaborating with small, specialized CROs. I have three preferred global CROs that I typically use for all my studies, as CROs with niche expertise are particularly valuable to us.
I prioritize having a 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 ensure you get the best value for your money.
We choose the right vendor, tailored to the specific requirements of the study. In our experience, it’s very important to have trustful local contacts. While we can outsource experts to the local sites, we prefer working with individuals who know the culture and speak the local language.
What is your vision of setting up a clinical budget?
I have validated templates from previous projects, including budget templates from small, niche CROs and the Top 5 global CROs. We set up bidding events with both small and large CROs to explore and compare their budget differences. Each CRO has its own unique approach to budgeting, which involves piecing together the puzzle and learning from it. Ultimately, every vendor incurs similar types of costs throughout the study.
The trick is to gather as much information as possible. I research at the micro level to identify the biggest cost drivers, such as project management and site visits. Negotiate the vendors’ hourly rates; costs can always be reduced by decreasing the number of resources. To ensure a transparent quote without unexpected costs during or after the study, establish an annual increase. It can also be helpful to organize the project budget in a timeline format, considering every activity or service, and which party is involved with each charge. This approach provides a clearer overview of individual services and who is responsible for them.
How can one build the right culture in a clinical department?
This is all about selecting the right people. The members of your clinical apartment have to be entrepreneurial, hands-on, and motivated. I prefer to work with people from previous companies or people who have been referred by people I trust. Additionally, avoid making your department’s operations overly complex with rigid procedures. Excessive protocols and lengthy discussions often lead to study delays. Sometimes we find that a CRO hides behind procedures, which makes them less flexible.
Make sure there is a balanced mix of personalities based on the DiSC model. This team should value the equal contributions of structured Blue thinkers, collaborative Green minds, decisive Red individuals, and out-of-the-box Yellow personalities. Read more about this here.
What is your advice on managing a study?
Collaborate with experienced professionals and understand that you remain responsible, even if your tasks are outsourced. Stay on top of your studies and challenge your CROs at all times. Ask why they do the things they do and measure them. Make sure you quickly respond to questions from your vendors to avoid delays and expect the same level of commitment to lead times from them. Make sure you receive the necessary overviews you need to oversee and manage. If a study is running behind, don’t be afraid to make swift changes with team members from the CRO team.
What is important in data capturing?
We always use Electronic Data Capture (EDC), even in the case of a small study, as it saves our company time significantly.
Invest in high-quality technology and avoid opting for lower-cost EDC solutions. Make this decision in collaboration with a clinical data expert and ensure the data is as accessible as possible. When choosing the right system for your type of study, always consider the site perspective. Ensure that the reporting system is safe and 100% clear. Don’t forget to keep the data management consistent. The best way to achieve this is to have a standard data collection tool across all your studies.
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