Phase IV: Gaining post approval insight

Phase IV clinical trials are conducted after the drug was approved by regulatory authorities and address the drug's indication with further interventions such as new drug combinations or use of certain technical devices. Consequently these trials may require large numbers of study sites to cover the extensive recruitment numbers. Our large site networks enable a quick identification of potential study sites to engage in such trials providing access to patients under physician driven treatment.

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Since Phase IV clinical trials aim at assessing certain aspects of the current drug use (e.g. confirming the benefit-risk analysis, new combinations, use of technology for manaing drug intake, mandated by authorities), it is key to define a protocol and study, which is well manageable for sites and patients. Our established processes coordinated by an experienced Project Management team ensure a streamlined study execution to evaluate the efficacy and safety in the long run and to detect any rare or long-term adverse effects over a much larger patient population than it was possible during Phase I-III clinical trials.

 

Phase IV trials are generally designed to test the drug in “real world” setting of the daily clinical practice while including a novel intervention or certain aspects for observation. Thus protocols with “wide” treatment schemes are often required. By means of our proprietary digital systems such as our Electronic Data Capture (EDC) system, data can be controlled for timeliness, accuracy, and completeness. Our risk monitoring, combining on-site, online and central monitoring enables us to guarantee safety and smooth running of each trial. Last but not least we constantly provide comprehensive knowledge and experience by all of our departments to cover the different demands during Phase IV trials.

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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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)
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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 (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 ..

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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