Phase II: Verifying your drug's efficacy

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 to find a design that fits that requirement and choose the sites which are experienced in the respective study indication. We elaborate explicit study designs including several safety steps as Phase II clinical trials are more complex and institutions like central laboratories have to be used for a standardized assessment over all study sites.

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Key to a great Phase II study is gathering a fast and reliable signal for the drug’s effectivenes while keeping track of safety signals. We set a high value on our monitoring activities since Phase II studies also pay attention to any short-term side effects and safety risks associated with the dosing of the investigational drug in order to optimize the dosing. For timely effectiness we offer a structured and streamlined Project Management to coordinate all steps and processes related to your clinical trial, which includes a structured risk management approach. Long-term experience won in cooperation over years with investigators will help our Regulatory Affairs team to select suitable sites. Our training and quality control grants an efficient study execution, beginning with site selection and followed by site initiation and constant monitoring.

 

Through our ongoing risk-based approach we assure compliance with ICH/GCP as well as local laws. We offer clear and concise protocols and presentation of study results which are penned by our medical writers. They are equipped with excellent written language skills and will ensure consistency with the different styles of the addressees. Our statisticians are concerned with validated statistical programming and development of analysis databases with complete audit trail and metadata according to CDISC standards, if required. In the end of Phase II clinical trials, they prepare the analysis of results for the clinical study report and support medical researchers in preparing their publications and scientific presentations in close collaoration with the sponsor.

In Phase II 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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