palleos healthcare is a full-service Clinical Research Organization (CRO). We offer a full suite of services for executing Phase I-IV clinical trials, Non-Interventional Studies (NIS), registry-based studies and medical device studies (incl. IVD). From initial planning to study closure, we offer comprehensive expertise across all facets of clinical research ensuring precision and tailored solutions for every stakeholder involved
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- and 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 (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 ..
We support our clients in clinical trials from phase I-IV
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
