Services

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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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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