Defined study responsibilities
Establishing the study contribution, endpoints and responsibilities across BerlinAnalytix and the participating GLP network.
A clear scope for conduct, evaluation and reporting.
All services
GLP regulatory
04 / GLP Regulatory Studies
GLP regulatory
studies.
Generating preclinical evidence for regulatory submissions through GLP study conduct, quality assurance and traceable reporting.
Submission studies with full GLP documentation and oversight.
The study scope
Evidence with a
reviewable record.
Connecting the commissioned preclinical investigation with the documented conduct, quality assurance and reporting required for its GLP scope.
Documented conduct and oversight
Maintaining the applicable GLP requirements through the study, including traceability, quality assurance and the reporting of the commissioned work.
Evidence that can be followed from the study record to the report.
GLP defines study conduct and documentation. The study model, endpoints and evidence requirements are established for the intended submission.
What the evidence reveals
From the specimen
to the study report.
Investigating the tissue endpoints relevant to the submission while retaining the records needed to understand how the evidence was produced.
Study-defined tissue endpoints
Assessing the tissue response, integration and other implant-specific endpoints commissioned within the study.
Product relevance · Providing the agreed histopathological contribution to the submission evidence.
Traceable preparation and evaluation
Connecting specimen identity, processing, sections and analytical evaluation within the documented study workflow.
Product relevance · Making the origin and handling of the evidence reviewable.
Documented findings and reporting
Reporting methods, observations and study-relevant results within the agreed responsibilities and quality-assurance framework.
Product relevance · Supporting review of the findings in their study context.
The regulatory contribution is scoped for the specific study. Earlier non-GLP work remains identified by its original study status.
Optional technical detail
How the evidence
is produced.
Preserving the relevant tissue and material features within a documented, study-specific preparation and evaluation workflow.
Explore processing & analysisProcessing and specimen traceability
Selecting undecalcified or soft-tissue processing around the commissioned endpoints and maintaining the link between specimen identity, preparation and the sections evaluated.
Defined staining and evaluation
Applying the study-defined staining and evaluation methods to the relevant endpoints. Recording the methods and interpretation required to understand the resulting histopathological and quantitative evidence.
GLP network and reporting responsibilities
Defining the responsibilities of BerlinAnalytix and the participating GLP network within the commissioned study. The scope establishes how study conduct, quality assurance, reporting and records fit together.
Your next investigation
What must your
submission establish?
Bring the device, intended submission and preclinical question. The study scope connects the required evidence with the responsibilities for generating and reporting it.
Discuss a GLP studyA useful starting point
- Medical device or biomaterial and intended submission
- Preclinical endpoints and existing evidence
- Required study contribution and partner responsibilities