Consortium for trial sites

Study Journey

The lifecycle of a clinical trial

Four specialised partners, one continuous process. From the first enquiry to audit-proof archiving, we support trial sites through every phase of a clinical trial – compliant, documented, from a single source.

The four partners Explore the journey

5: phases
4: partners
8: ongoing services

Sequence

Five phases, one continuous process

Every clinical trial passes through the same stations – and they all converge at the trial site. We cover all of them, with clear responsibilities at each handover.

01
Preparation

Feasibility assessment, costing and contracting – the decisions that shape the timeline and quality of the entire trial.
- Enquiry
- Feasibility
- Budget/contract
02
Approval

Submission to competent authorities and the ethics committee, compilation of study documents and site initiation.
- Authority
- Ethics committee
- Initiation
03
Recruitment

Identifying eligible patients, obtaining informed consent in line with GCP and enrolling them into the trial.
- Screening
- Informed consent
- Randomisation
04
Conduct

The longest phase at the trial site: treatment per protocol, investigational product handling, monitoring, pharmacovigilance and ongoing documentation.
- Treatment
- IMP handling
- Monitoring
- Safety
- Documentation
- Document maintenance
05
Close-out

Close-out visit, audit-proof archiving for the statutory retention periods and documented destruction.
- Close-out
- Archiving
- Destruction

Continuous

Ongoing services across all phases

These services do not run sequentially – they run in parallel to every phase of the study journey, taking load off the trial site for the entire duration.

Quality management
Regulatory affairs
Training
Digital study documentation
Data management
Quality assurance
Compliance
QTSP

A strong network

for the successful conduct of your trials.

Four companies for the digital transformation of trial sites across the entire data lifecycle.

D·M·I GROUP

Data-sovereign healthcare.

For more than 60 years, DMI GROUP has supported hospitals in handling health information securely. With its companies DMI, Health-Comm, Gefyra and timeproof, it combines expertise along the entire value chain of health data – from legally compliant preservation through interoperable networking to use in care, management and innovation.
With XQT (Exchange Qualified Trust), DMI GROUP makes this combined strength visible. The service promise helps hospitals build data sovereignty and reliably meet regulatory, economic and technological requirements.
QM-Beratung Schairer

Quality management and SOPs for clinical research.

Building working quality management systems for GCP-relevant processes – with licensed SOP templates, process analyses and independent audits, at short notice ahead of announced inspections if required.
IFKS

Clinical training for medical and non-medical investigators.

The Institut für Fortbildung Klinische Studien trains investigators, study nurses and pharmacy staff – GCP courses under AMG, MDR and IVDR, aligned with the German Medical Association’s requirements and complemented by webinars on SOPs, data protection and eISF.
studio.201

Custom software for research and study management.

studio.201 develops web-based process software for clinical research: ISF+ for document management at trial sites and studioMED+, a clinical study information system for data, documents, appointments and people – in use at hospitals across Germany.