Services - GCP-Service

GCP-Service offers two service models depending on the needs of the sponsor:

Best for organizations lacking:

Both models enhance your clinical trial. Our flexibility allows us to provide our expertise where needed and we can work according to clients SOPs or with our own SOPs.

Our Services

Biostatistics

Starting a trial can be overwhelming for sponsors. They must devise a precise plan that supports the trial's objective and aligns with desired marketing claims.

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Clinical Data Management

Data matters! Understanding data in clinical trial execution is crucial. Effective data governance, infrastructure, and ecosystem lead to success.

Further information

Project Management

Our international Project Management team at GCP-Service provides expert study coordination with oversight and transparency.

Further information

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.

Further information

Regulatory Affairs

The regulatory start-up process is critical for clinical trials. Delays can impact study timelines. We prioritize ensuring a timely start-up for your trial.

Further information

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.

Further information

Medical Devices and IVDs

The Task Force Groups assist medical device manufacturers with the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Further information

Medical and Scientific Writing

Whether writing a publication, a study protocol, or a report – conveying a clear message is at the centre of it.

Further information

Clinical Operations

We actively support clients developing innovative health products, including pharmaceuticals and medical devices.

Further information

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.

Further information

Legal Representation

Legal representation facilitates EU clinical studies, a major step for smooth study conduct.

Further information

Biostatistics

Starting a trial can be overwhelming for sponsors. They must devise a precise plan that supports the trial's objective and aligns with desired marketing claims.

Further information

Clinical Data Management

Data matters! Understanding data in clinical trial execution is crucial. Effective data governance, infrastructure, and ecosystem lead to success.

Further information

Project Management

Our international Project Management team at GCP-Service provides expert study coordination with oversight and transparency.

Further information

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.

Further information

Regulatory Affairs

The regulatory start-up process is critical for clinical trials. Delays can impact study timelines. We prioritize ensuring a timely start-up for your trial.

Further information

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.

Further information

Medical Devices and IVDs

The Task Force Groups assist medical device manufacturers with the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Further information

Medical and Scientific Writing

Whether writing a publication, a study protocol, or a report – conveying a clear message is at the centre of it.

Further information

Clinical Operations

We actively support clients developing innovative health products, including pharmaceuticals and medical devices.

Further information

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.

Further information

Legal Representation

Legal representation facilitates EU clinical studies, a major step for smooth study conduct.

Further information