7 questions to ask yourself before you choose to set up your own Clinical Data Management department.
The arguments to set-up your own Clinical Data Management department are various. You want to learn something new. You can do Clinical Data Management yourself because you could allocate resources for it. Conducting Clinical Data Management in-house could get you more in control of your clinical study (data). Clinical Data Management done in-house could cost you less. You could perform Clinical Data Management better yourself. You want to spend your Clinical Data Management budget internally. You see a chance to make (more) money. You see a chance to (better) serve your Customers. You want to complete the gap in your clinical service(s). Etc.
Before you make this decision you could ask yourself 7 questions:
For what type of studies should I want to conduct clinical data management myself? For all the studies I have? For the first clinical trials in the market application process? For phase III/IV clinical trials? For clinical studies conducted post registry?
Does a Clinical Data Management group fit in; does it add value to my company’s core business? Is dedication to Clinical Data Management performance part of my daily business targets?
Do I have enough studies, enough workload for Clinical Data Management to return investments? Is the cost-benefit ratio in my advantage?
Can I allocate enough resources, e.g. time, capacity, knowledge and money to the Clinical Data Management department to get clinical data quality from it?
Is this the right moment? Right now; should I invest in setting up a new department in my company? Is my company ready for this next step; an own Clinical Data Management group?
What are the benefits for my organization when we can conduct Clinical Data Management ourselves? What will it bring us?
What are the requirements for this Clinical Data Management department regarding the type of studies and the amount of studies. What are our user requirements for a Clinical Data Management system(s)? What is the capacity we need to handle that Clinical Data Management system and what knowledge is necessary?
The number one question in my experience; is a Clinical Data Management department a logical fit within your company’s core dedication? Logical like ‘clinical research to get your products accepted for marketing’ or ‘providing clinical research services’. Because dedicated Clinical Data Management can return investments.
© 2010 ProCDM, Maritza Witteveen
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