Throughout the entire assay development process we encourage an open communication with your team. We share our findings and involve your people in the real-time project decisions. Good involvement means no waste of time, labor and money.
PHASE 0 Proposal
The goal is to set a clear view of the customer’s wishes and needs. Together we summarize the scope, set indicative timelines and an indicative budget for the total project.
PHASE 1 Definition
The terms of deliverables, timelines and budget are set in detail. We define the project, perform pre-feasibility experiments and prepare all required documents for the Feasibility and Optimization Phase.
PHASE 2 Feasibility & Optimization
Feasibility and optimization of the assay design is performed to meet the design requirements and to be compatible with manufacturing requirements.
PHASE 3 Verification
A design freeze is achieved by establishing all critical parameters, e.g. raw materials, composition of assay compounds and design of assay execution protocol.
During the verification phase two verification lots will be produced at R&D and benchmarked against the design requirements. Accelerated stability studies will be performed for indicative shelf life data.
PHASE 4 Technical Transfer
After a successful verification phase, the manufacturing documents and all processes used for the verification lot production will be transferred to the manufacturing site (either at Future Diagnostics or our customers site).
PHASE 5 Validation
Technical and clinical performance of the assay produced at manufacturing site of Future Diagnostics is validated. For validation, 3 kit lots will be produced by manufacturing under ISO13485 and released by QA. These kit lots will be labelled for Investigational Use Only (US) / Performance Evaluation Use Only (CE) and can be used for clinical and technical validation. The data generated in the validation phase can be used for filing of the assay at notified bodies.
PHASE 6 Closure
Transfer of all technical data and documentation, complete design history file and team evaluation to the customer.
We use several tools to make communication easy and frequent:
- dedicated teams and clear responsibilities
- frequent conference calls/ online meetings
- direct access to your data through secure ICT platforms
- clear documentation during the project cycle
To meet timelines and realize the best possible results we use modern project management techniques like LEAN. We know it is important is to stay flexible and agile in diagnostic innovations. Early involvement of Future Diagnostics within assay development projects means that we are able to consult and save you from possible bottlenecks. Please feel free to contact us and discuss potential opportunities.