Project Management designs and coordinates all study-related processes, stakeholders, timelines, and responsibilities, from the initial study concept through to the final report and publication. The team ensures that sponsor responsibilities and study activities are carefully planned and optimized with regard to resources, budget, contracts, timelines, and compliance with applicable regulatory requirements.

During the initial planning phase, Project Management:

• provides regulatory guidance and budget planning,
• supports feasibility assessments of study concepts,
• assists with funding applications, and
• supports the drafting and negotiation of contracts.

Comprehensive, quality-assured templates are available for the preparation of all required study documentation during trial set-up, submissions to ethics committees and regulatory authorities, and trial conduct. The Trial Management and Support Unit actively supports:

• the preparation of study documents, and
• regulatory applications, notifications, and approval processes.

During study conduct, Project Management serves as the central point of contact for trial sites, project partners, and clinical monitors. Its responsibilities include:

• addressing emerging issues and operational challenges,
• overseeing study progress, budgets, timelines, and performance metrics,
• coordinating all involved partners,
• managing reporting activities,
• coordinating study logistics, and
• conducting quality control activities and overseeing risk-based quality management (RBQM) and risk-based monitoring processes.

After completion of the clinical phase of a trial, Project Management:

• coordinates trial site close-out activities,
• prepares final study reports in collaboration with the Principal Investigator, Biostatistics, and Data Management teams, and
• ensures the compliant archiving of all trial documentation.

Biostatistics provides scientific support for the planning and design of clinical trials. The unit is responsible for statistical consultation, biometric evaluation, and the statistical analysis of clinical research data generated during the trial.

Its core functions include:

• designing clinical studies in close collaboration with internal and external partners,
• advising on study design, target populations, and endpoint definitions,
• developing statistical methodologies and calculating sample sizes,
• conducting interim and final statistical analyses, and
• reporting and interpreting statistical results.

During the study preparation phase, Biostatistics develops the statistical sections of the trial protocol, the randomization plan, and the statistical analysis plan. Throughout the study, the team performs interim analyses and prepares statistical reports. 

At study completion, Biostatistics is responsible for the final statistical analyses, preparation of study reports, and interpretation of results. The unit also provides substantial support for scientific publications arising from the trial.

Data Management ensures the integrity, availability, and validity of study data from initial collection through statistical analysis by applying organizational, methodological, conceptual, and technical measures. The team contributes to trial protocol development and study set-up and develops Case Report Forms (CRFs) using modern technologies to facilitate the collection of high-quality and reliable data.

During the study, key responsibilities include:

• monitoring the complete data flow, including centralized data monitoring in support of RBQM,
• developing and implementing trial-specific quality control measures for study data, and
• programming, processing, and evaluating study data for reports, presentations, study meetings, final study reports, and scientific publications.

Quality assurance, documentation, and validation are integral components of all relevant data management processes.

Risk-based Quality Management is a fundamental component of Good Clinical Practice (GCP) and therefore a central element of the work performed by the Trial Management and Support Unit. It encompasses a broad range of coordinated and standardized processes, as well as working documents, templates, and checklists.

The unit supports risk-based quality management in accordance with the current ICH-GCP guidelines throughout the entire duration of a clinical trial.

Study Nurses and Clinical Trial Assistants (CTAs) support both trial conduct and project management activities. While CTAs provide cross-functional organizational, administrative, and coordination support throughout the study process, Study Nurses are responsible for coordinating clinical care, ensuring participant safety, maintaining protocol adherence, supporting accurate data collection and documentation, and ensuring appropriate participant follow-up.

Medical Information Scientists support the conduct of clinical trials, particularly through the development and maintenance of database solutions for trial management. They support the IT infrastructure of the Trial Management and Support Unit and provide databases for trial management, data migration interfaces, and IT solutions for registry studies.

In close collaboration with the Data Management team, Medical Information Scientists ensure the continuous availability of efficient solutions for paperless electronic data capture and data processing. In addition, they play a key role in implementing and maintaining data protection measures.