Phase I: Establishing reliable safety signals

In Phase I trials, where information about the compound’s effects in humans is limited, we step in with services designed to ensure strict and timely measures, safeguarding patients’ rights and well-being. The decisions made during Phase I can significantly influence later phases and the drug's market positioning. Trust us to navigate the crucial early stages with precision and care.

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We specialize in full Phase I clinical trial services, offering innovative study concepts and ensuring meticulous long-term supervision.

With our regulatory expertise, we navigate the complex landscape of legal and ICH-GCP guidelines, guaranteeing a successful and timely study setup. From essential document preparation to site identification and regulatory submissions, we prioritize patient safety and regulatory compliance.

Our vigilant monitors, trained in various methods including risk-based monitoring, mitigate inherent safety risks in Phase I trials.

The Pharmacovigilance & Materiovigilance department plays a crucial role — they ensure swift information transfer and monitoring through bodies like the Data and Safety Monitoring Board (DSMB) and Safety Review Committee (SRC) and aim for the determination of the Maximum Tolerated Dose (MTD).

Our commitment ensures the trial progresses on time and within budget, yielding accurate safety signals.

In Phase I 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

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

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Phase III

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

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Phase IV

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

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About us

 

„Recognizing the next opportunity when it matters the most.“

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