Work package 1: Scientific Management & Joint Data Analysis
Description of the work package
This work package aims at managing all scientific aspects of the LENA project and jointly analysing all data generated by the work packages. In contrast to work package 15, whose focus is overall project management, work package 1 will focus its efforts specifically on the scientific content of the LENA project. In order to promote timely finalization of all deliverables, a permanently moderating scientific contact portal between all project partners will be provided. Work package 1 will therefore be able to promptly address hurdles likely to affect deliverable generation and will help to ensure the progress of the project. In this respect, work package 1 is organized as a central scientific unit that prospectively helps to keep all LENA timelines on target. Furthermore, work package 1 will jointly analyse all data generated in the other individual work packages to integrate them into a whole picture, thus making sure that the overall impact of the LENA project is achieved.
Work package 1 personnel has specific expertise in management of paediatric trials involving cardiovascular drugs, data generation, blood sample analysis, and modelling and simulation. Therefore, this work package is in a position to prospectively foresee and address issues concerning the generation of deliverables of clinical trial work packages to ensure timely finalization.
We are focusing on the following aspects:
- Performing scientific project management: Scientific review of all scientific and clinical documents, coordination of concept protocols and protocols of paediatric studies, coordination PBPK/PD analysis with clinical studies, scientific alignment between paediatric studies, coordination of laboratory activities linked to the LENA project (including quality assurance and interaction with data management and statistics for scientific and clinical analysis), and scientific support of PIP and PUMA.
- Supporting the project partner Ethicare GmbH with regard to clinical sponsor function: Production of the clinical batches of enalapril for all four clinical studies in the LENA project under GMP guidelines will be supervised by project partner UDUS and project partner Ethicare in close collaboration with each other.
- Interactions with the Data and Safety Monitoring Board (DSMB) and the Ethical & Scientific Advisory Board (ESAB).
- Joint analysis of all data generated in the individual work packages.