Clinical Services
Clinical trial biopsy management
Bioassays - Biomarkers
Consulting
- Site preparation
- Site assessment
- Biopsy tool and supply kits
- Biopsy processing manual
- Site personnel training
- Training video
- Training quiz
- Live-streamed or on-site biopsy processing training
- Site monitoring; shipment
- Management of site personnel
- Real-time observations; live-streamed or on-site
- Shipping management (initiation, tracking/monitoring, QC, storage)
- Follow-up letters and reports
- Aliquoting, in-house bioassays, shipping to additional vendors
- Off-the-shelf, pre-validated bioassay
- Dystrophin immunoblot (FDA audited)
- Proteins
- Immunoblot
- Immunostaining
- Mass spectrometry
- Luminex, ELISAs
- LIPS (Luciferase Immuno-Precipitation System)
- Frozen aliquots, storage, shipping
- QA/QC, reporting
- RNA
- Isolations
- RT-PCR (gels)
- qRT-PCR
- RNAseq (nextgen)
- Aliquots, storage, shipping
- QA/QC, reporting
- Histology
- Bioassay development
- Bioassay validation
- Biomarker context of use; fit for purpose
- Integration of biomarkers in the clinical protocol
- Regulatory consulting
- FDA (orphan designation, surrogate biomarkers, clinical outcomes, trial design)
- EMA (CHMP, PDCO PIP) (orphan designation, clinical outcomes, trial design)
- Clinical trial design, conduct
Frozen Tissue Banking
- Inventory management
- Freezer monitoring
- Back-up generator
- Repeat accessioning
- Follow on bioassays
- Aliquot send-outs