Phase III: Ensuring drug approval

Today's protocols, especially in Phase III, grow in complexity, due to regulatory and sponsor requirements. Key in setting up a Phase III study thus is to manage complexity by finding the right mix of country coverage, statistical/protocol design, as well as study and risk management, together with the study sponsor.

Phase III studies are often multi national and multi center trials based on results from the product’s earlier Phase I and II clinical trials. They are mostly required to register a drug with regulatory bodies in order to acquire marketing approval.

Our site netowrk, partners and specifically our role in the ONE Clinical Trial Alliance allows us to engage in these trials. Furthermore our regulaotry professionals are able to select optimal candidates for quick recruitment. To make sure your trial is adequately attuned to your drug approval strategy, we provide advice from experienced drug development specialists.

We offer a thorough selection of potential sites through feasibility, based on our preliminary assessment and by former experience. Our risk monitoring approach combines on-site, online and central monitoring, to control risks making sure monitoring resources are adequatly employed.

In Phase III we provide you with the following services

Sponsor Services

Quality Risk Management

Project Management

Regulatory Affairs

Monitoring

Data Management

Medical Writing & Medical Monitoring

Safety & Pharmacovigilance

Statistics

Technology (EDC, CTMS, Safety Database and Eudravigilance services)

Sponsor Services

The Sponsor is central to the execution of any clinical trial, as he is responsible for guaranteeing compliant trial execution according to ICH/GCP and other trial
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Quality Risk Management

One of the most important developments in clinical trial conduct during recent years is the advent of risk-based thinking, introducing a paradigm shift from controlling quality
read more ..

Project Management

Any project requires an adequate initiation, planning, controlling and finalization. Specifically clinical research, with its regulatory requirements concerning trial application
read more ..

Regulatory Affairs

Approval of relevant study documents by competent authorities and ethic committees is the key requirement for setting up a clinical trial. A concordant positive
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Monitoring

Monitoring of clinical trials is a quality assurance measure to ensure patient safety and data integrity. Typical monitoring activities are the "Source Data Verification" (SDV) and
read more ..

Data Management

Clinical Data Management is the crucial interface between acquisition and interpretation of essential data in clinical trials. Core to data management is the structured design
read more ..

Medical Writing & Medical Monitoring

Medical writers accomplish the challenge to cover the width of the medical disciplines in order to develop sophisticated scientific documents or delivering supporting clinical development
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Safety & Pharmacovigilance

Patient safety is a central aspect in any stage of clinical research and the primary measure required for this purpose is the adequate processing of any reported adverse event (AE)
read more ..

Statistics

The primary function of statistics is to handle uncertainty in a rigorous fashion to arrive at accurate inference and decision making. This is especially important in clinical research
read more ..

Technology (EDC, CTMS, Safety Database and Eudravigilance services)

The Sponsor is central to the execution of any clinical trial, as he is responsible for guaranteeing compliant trial execution according to ICH/GCP and other trial
read more ..

One of the most important developments in clinical trial conduct during recent years is the advent of risk-based thinking, introducing a paradigm shift from controlling quality
read more ..

Any project requires an adequate initiation, planning, controlling and finalization. Specifically clinical research, with its regulatory requirements concerning trial application
read more ..

Approval of relevant study documents by competent authorities and ethic committees is the key requirement for setting up a clinical trial. A concordant positive
read more ..

Monitoring of clinical trials is a quality assurance measure to ensure patient safety and data integrity. Typical monitoring activities are the "Source Data Verification" (SDV) and
read more ..

Clinical Data Management is the crucial interface between acquisition and interpretation of essential data in clinical trials. Core to data management is the structured design
read more ..

Patient safety is a central aspect in any stage of clinical research and the primary measure required for this purpose is the adequate processing of any reported adverse event (AE)
read more ..

The primary function of statistics is to handle uncertainty in a rigorous fashion to arrive at accurate inference and decision making. This is especially important in clinical research
read more ..

Learn more about

Phase II

Phase II studies are designed to gain information on the drugs effectiveness. In this context the design is as important as the sites chosen to execute the study. We thus attach great importance

Network

„Inspire and being inspired – our network of partners, sites and KOLs makes us ready to meet every challenge.“