Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 43

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 43
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 with the applicable protocols as well as applicable legal and regulatory requirements and scientific standards, or report the 

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results obtained in a timely and accurate manner. We need to have mechanisms in place to adequately manage, oversee and control our clinical trials, including selection of CROs, auditing activities, focus on set-up (during which deliverables, timelines and roles and responsibilities are defined), and oversight during the conduct of clinical trials. We, our CROs, as well as the clinical sites and investigators are required to comply with current Good Clinical Practices (GCPs) and GDPs, which are regulations and guidelines enforced by the FDA, the competent authorities of the member states of the European Economic Area, or EEA, and comparable regulatory authorities for all of our products in clinical development. Regulatory authorities enforce these requirements through periodic inspections of trial sponsors, investigators and clinical sites. Upon inspection by a given regulatory authority, such regulatory authority may determine that any of our clinical trials do not comply with GCP and GDP regulations. If we, any of our CROs or any of the clinical sites or investigators fail to comply with applicable GCPs GDPs or other applicable requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, EMA or comparable regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. 
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In addition to GCPs, our clinical trials must be conducted with products produced under current Good Manufacturing Practice (cGMP) regulations. Failure to comply with applicable protocols and regulations in the conduct of the clinical trials for our product candidates may require us to repeat clinical trials, which would delay the regulatory approval process. 
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If any of our relationships with these CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on similar terms. In addition, switching or adding additional CROs involves additional cost and requires management time and focus. If CROs do not carry out their contractual duties or obligations successfully or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure (including by clinical sites or investigators) to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates and our costs could increase substantially. 
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If the third-party data and results we rely upon