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.

palleos focusses on an integrated service approach in order to streamline every stage of a clinical trial from set-up to closure and perform our projects more efficiently. Yet, we also offer tailored service solutions. The internal Quality Management (QM) ensures constant quality assurance. Individualized contact offers you quick and solution-orientated assistance in your project.

As a service, we also take on the sponsor role in clinical trials. In line with the ICH-GCP guidelines this encompasses the responsibility for initiation, management and financing of a clinical study. In order to meet these requirements we utilize a quality risk management approach aligned with regulatory demands. Being in charge of sponsorship we provide continuous study oversight and guarantee a smooth conduct of each trial.

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

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

Network

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