Phase III: Ensuring Drug Approval

In Phase III, where protocols surge in complexity, skilled management is crucial.
We set-up each Phase III study precisely, balancing country coverage, statistical/protocol design, and robust study and risk management. Our approach aligns seamlessly with both regulatory and sponsor requirements, ensuring a path to successful drug approval.

clinical-trials-phase 3

In the expansive landscape of Phase III, often spanning multiple nations and sites, our approach builds on the success of prior Phase I and II trials.

As a vital link in our site and partner network, we seamlessly engage in multinational endeavors.

Leveraging our extensive site network and feasibility assessments, we offer a thorough site selection process, selecting optimal candidates for swift recruitment.

We apply a continuous risk monitoring approach, integrating on-site, remote, and central monitoring to ensure resource efficiency and robust risk control.

In Phase III 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

Network

 

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

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