GCP-Service International Ltd. & Co. KG. offers its services via two different service provider models depending the needs of the sponsor. Our Service Strategy offers a Full Service and a Functional Service Provider Model.
Full Service Model (FS Model)
Our team is capable to provide all services for the conduction of a clinical study under one roof. For companies that do not have the expertise and or manpower to conduct clinical studies on their own, GCP-Service can deliver full service support. The advantage is that the sponsor does not need to find any additional vendor, has less vendor qualification and vendor management costs and has one key point of contact. Short paths of internal communication and the close contact to the customer ensure effective and resource saving processes. Our full service is not limited to any region, medical indication or service types.
Functional Service Provider Model (FSP Model)
This model works well for organizations that mainly have their own capabilities but need support with particular project tasks like clinical monitoring in a specific region, Data Management Services, Biostatistics, EDC or Safety processes. GCP-Service provides all services also on demand. Our staff is used to work according to client SOPs within the FSP model.
Our services
Biostatistics
Biostatistics
We know that starting a trial can seem like an overwhelming task. As a Sponsor, you need to devise a precise plan that supports the objective of the trial, and ideally also aligns with the desired marketing claims....
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Clinical Data Management
Clinical Data Management
Great data matters! In-depth understanding of data in clinical trial execution is crucial. Using effective data governance as a starting point, combined with the right data infrastructure and ecosystem is simply a success story...
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Project Management
Project Management
Our international Project Management team at GCP-Service offers expert coordination of your study by offering oversight and transparency throughout the duration of the study....
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Sponsorship as a Service (SPaaS®)
Sponsorship as a Service (SPaaS®)
The new MDR requires small to midsize medical device companies to take over the ‘Sponsor responsibilities’ for their clinical trials...
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Trial Master File & Document Management
Trial Master File & Document Management
At GCP-Service we believe that TMF oversight, control, and inspection readiness are vital to the success of your clinical trial. ....
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Regulatory Affairs
Regulatory Affairs
The regulatory start-up process is the first critical path of a clinical trial. Even small delays can impact entire study timelines. At GCP-Service we believe it is most important that we ensure a timely start-up of your clinical trial....
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Product Vigilance Services
Product Vigilance Services
The safety of patients always come first, however the reporting of safety related events within clinical trials is crucial and can be tricky...
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Medical Devices and IVDs
Medical Devices and IVDs
The Medical Device and IVDs Task Force Groups are designed to help medical device manufactures with all aspects of the new Medical Device Regulation (MDR) and the new In Vitro Diagnostic Regulation (IVDR).
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Clinical Operations
Clinical Operations
Our clients develop highly innovative health products such as pharmaceuticals and medical devices and we support them actively. We offer a broad range of clinical operational services...
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Legal Representation
Legal Representation
Legal representation unlocks the EU to your clinical studies. This of course is a major step towards getting your study started and ensuring a smooth study conduct....
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Medical and Scientific Writing
Medical and Scientific Writing
Whether writing a publication, a study protocol, or a report – conveying a clear message is at the centre of it...
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