Executing clinical trials with a novel touch

Palleos is a full-service clinical research organization (CRO) providing services for Phase I-IV clinical trials ranging from planning to closure of the clinical study and offering profound expertise in Project Management, Regulatory Affairs, Monitoring, Data Management, Medical Writing & Medical Monitoring, Safety & Pharmacovigilance and Statistics, always keeping in mind the individual needs of every client.

We provide 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
read more ..

Project Management

Any project requires an adequate initiation, planning, controlling and finalization. Specifically clinical research, with its regulatory requirements concerning trial application
read more ..

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
read more ..

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 ..

Clinical Innovation Platform

The clinical innovation platform in cooperation with phaon scientific: Independent research with indsutry partnering for trial development, execution and publication.

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Phaon Scientific

develops innovative and robust trials by applying modern statistical tools

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Palleos

tackles increasing complexity and regulatory hurdles through focus on essential in trial operations

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Phaon Scientific

ensures efficient knowledge distribution to establish innovations throughout the medical community

We conceptualize and conduct clinical studies for digital health applications (DIGAs)

 

palleos healthcare provides services from consulting on scientific advice meetings, trial design and trial execution, covering the complete DiGA process for medical devices.

 

Many new medical products with applications (apps) are currently being developed. Through the promotion of digital health apps (DiGA), an “app on prescription” – i.e. reimbursement by the health insurance funds – is made possible in accordance with the “Digital Health Care Act” – (DVG).

The BfArM usually requires clinical studies to prove the positive health care effect, whereby the studies must fullfil very high quality standard in accordance with medical device regulations.

The BfArM procedure to enter the “DiGA” library is designed as a “fast track” process over 3 months. In the review process, data protection, user-friendliness and the positive care effect of the DiGA are evaluated on the basis of clinical data and/or clinical studies. Extensive and valid clinical data must be submitted so that a positive supply effect can be proven. In case no sufficient data points can be provided, the manufacturer may also be provisionally listed in the DiGA directory thus being eligible for reimbursement. Such can be achieved by conducting a randomised study within a trial period of up to a maximum of two years, which has to be accepted by the BfArM for eligibility. As soon as a DiGA is listed in the directory, it is eligible for reimbursement, so that the DiGA can already be billed via the health insurance funds.

DiGA Fast Track Process Overview

Sponsor Service

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

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

Project Management

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

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

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

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

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

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)

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

Biosimilar

As the importance of Biosimilar in today’s market rapidly increases, we offer our in-depth expertise for conducting clinical trials in this area. The production of highly complex Biosimilar