Consortium for clinical trials
Study Journey
The lifecycle of a clinical trial
Four specialised partners, one continuous process. From the first enquiry to audit-proof archiving, we support clinical trials across every phase – compliant, documented, from a single source.
- 5
- phases
- 4
- partners
- 7
- ongoing services
Sequence
Five phases, one continuous process
Every clinical trial passes through the same stations. 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.
- 02
Approval
Submission to competent authorities and the ethics committee, compilation of study documents and site initiation.
- 03
Recruitment
Identifying eligible patients, obtaining informed consent in line with GCP and enrolling them into the trial.
- 04
Conduct
The longest phase: treatment per protocol, investigational product handling, monitoring, pharmacovigilance and ongoing documentation.
- 05
Close-out
Close-out visit, audit-proof archiving for the statutory retention periods and documented destruction.
Stakeholders
Who hands over when
The trial chain from sponsor to close-out – the CRO coordinates between the site and the data flow.
- Sponsor
- Trial site
- Patient
- Data
- Close-out
coordinates site, patient data and feedback to the sponsor
Continuous
Ongoing services across all phases
These services do not run sequentially – they run in parallel to every phase of the study journey.
- Quality management
- Regulatory affairs
- Training
- Digital study documentation
- Data management
- Quality assurance
- Compliance
Consortium
The four partners
Four independent companies with clearly delineated competencies – together they cover the complete study journey.
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D·M·I GROUP
Your partner for clinical research and development.
D·M·I supports pharma, biotech and medtech companies in planning and conducting clinical trials – worldwide and to the highest quality standards.
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Good Clinical Practice
Your specialists for GCP and research services.
Good Clinical Practice provides hands-on training, audits and consulting for GCP compliance and regulatory requirements.
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IFKS
Knowledge that advances. People who make a difference.
IFKS imparts medical knowledge and fosters exchange – for better care tomorrow.
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studio.201
Digital solutions for research and study management.
studio.201 develops tailor-made software solutions for clinical trials – secure, flexible and future-proof.
Contact
Planning a clinical trial?
Get in touch – we will clarify feasibility, timeline and responsibilities in an initial conversation.
Prefer to email us directly? info@studyjourney.201.de