Phase IV: Gaining post approval insight

Phase IV is the stage where approved drugs reveal even more potential. These trials explore new combinations or innovative device use, often requiring numerous study sites for extensive recruitment.
Our large site network enables us to swiftly identify ideal sites, granting study access for patients undergoing physician-driven treatments.
Let's uncover the possibilities post-approval!

clinicaltrials-phase 4

In Phase IV, our focus extends beyond approval, delving into real-world drug use scenarios. The larger patient populations enable detailed evaluations of efficacy and safety, capturing rare or long-term signals.

Critical to success, our experienced Project Management team ensures streamlined execution with protocols designed for manageability and effectiveness. Embracing a ‚real-world‘ perspective, we implement broad treatment schedules and proprietary digital systems like our Electronic Data Capture (EDC) system for precise data control.

Our comprehensive risk monitoring, integrating on-site, remote, and central approaches, guarantees safety and seamless trial operations.

With expertise spanning across departments, we confidently meet the diverse demands of Phase IV trials.

Let’s uncover insights in the everyday clinical landscape together!

In Phase IV we provide you with the following 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
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Project Management

Any project requires an adequate initiation, planning, controlling and finalization. Specifically clinical research, with its regulatory requirements concerning trial application
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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
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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
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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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Pharmaco- & Materiovigilance

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)
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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
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Technology (eTMF, EDC, CTMS, ePRO, Safety Data-base, EudraVigilance, and more)

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 ..

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
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

Services

 

“Risk is inherent to any project and many take risks in their trials. We control risk.”

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