Central Laboratory Services
Clinical Trial Services
Testing Services
Kit Creation
Biorepository
PBMC Isolation
High quality laboratory testing starts at sample collection.
Success of your trial depends on laboratory experts understanding of the full lifecycle of your samples, preanalytical through postanalytical/data integrity.
Select from 500+ inhouse assays or ask us to develop an assay just for your study. Make use of our industry-leading turnaround times to achieve your timeline goals. Turnaround times range from 24-hour esoteric assays or 48-hour gene sequencing assays to cost-effective batch analysis.
Why test with us:
- 500+ assays to choose from, with industry-leading turnaround time
- GLP or CLIA method validation in weeks, not months
- Kit solutions for frozen, refrigerated and room temperature samples
Our Approach to Quality
Therapeutic Areas
- Advanced Genetics
- Cardiology
- Coagulation Disorders
- Complement Disorders
- COVID-19
- Hematology
- Immunology
- Nephrology
- Medical Devices
- Oncology
- Ophthalmology
- Pharmacogenomics
- Platelet Disorders
- Rare Disease
- Visitless (Virtual) Trials
Our Regulatory Proficiencies
College of American Pathologists
Clinical Laboratory Improvement Amendment
Good Laboratory Practices
Good Clinical Practices
General Data Protection Regulation
In Vitro Diagnostic Regulation (EU)
Popular Assay Types
- Cell-based assays
- Chemiluminescent assays
- Chromogenic assays
- Coagulation assays
- ELISA
- Flow cytometry
- Latex Immunoassays
- PBMC Isolations
- Platelet aggregation
- Thrombin generation Assay
- Thromboelastography
- Western Blot
- Inversion Assays
- MLPA for CNV
- Next Generation Sequencing (NGS)
- RNA Seq
- RT-PCR
- Sanger Sequencing
- SNP Assays
- Whole Exome Sequencing
- Whole Genome Sequencing
- Digital PCR
- Long Read Sequencing
Machaon Kit Solutions
- Expedited kit solutions (frozen, room temperature and ambient samples)
- Lab manuals and collection processing guides
- Comprehensive supplies with manifests
- Remote kit inventory monitoring with automated replenishment
- Kit distribution management with expiration date tracking
- Long-term storage biorepository solutions (-80°C, -20°C, 2-8°C and ambient temperatures)
Your Ultimate R&D Partner
We develop blood marker, biochemical, genetics and cell biological assays
- Expertise measuring labile blood markers
- Expertise miniaturizing assays
- Customization of an assay
- Measure drugs of interest
- Measure analyte in sample matrix of interest
- PK/PD assays
- IC50 assays
- Functional verification of variants of unknown significance
Your Medical Device Trial Services Partner
- New analyzer market entry
- Comparison against a predicate device
- Point of Care (POC) device studies
- Accuracy sample sourcing
- Rare sample sourcing
- New Reagent evaluation
- Control lot creation and calibration
- ISI calibration
- Contrived sample creation
- Stability studies
Biorepository Services
- Electronic sample location mapping
- Temperature controlled storage
- 24X7 Temperature monitoring
- Generator power backups
- Long-term storage
- Easy sample retrieval
- Chain of custody documentation
- Manifest creation
- In transit temperature controlled
Our Business Process
Client
Inquiry
Study
Quote
Breakdown
Master Service
Agreement
Work Order
Service
Profile: Project Manager
Jacob Cota
Quote:
“Our workflows are designed to weave quality metrics throughout each study design, while delivering results on expedited timeframes.”
Jacob Cota
Blood, Sweat and Smears is a podcast hosted by Dr. Brad Lewis. This podcast focuses on bleeding, clotting and complement-mediated disorders, as well as related news and events shaping current approaches in clinical management and laboratory medicine. Dr. Lewis shares his insights and knowledge, built over his four decades as a benign hematologist.
Example of Our Deliverables
- Study Plan Agreements (SPA)
- Material Transfer Agreements (MTA)
- Data Transfer Agreements (DTA)
- Data Use Agreements
- IRB-approved Protocols
- Informed Consent Forms (ICF)
- GLP Method Validation Reports
- CAP/CLIA Method Validation Reports
- Roles and Responsibilities Logs
- Staff Training Reports
- QAU Audit Reports
- Case Report Forms (CRF)
- Trial Master Files (TMF)
- Electornic Trial Master Files (eTMF)
- GLP Bioanalytical Study Reports
- CAP/CLIA Bioanalytical Study Reports
- Biorepository Sample Storage Reports
- Study Close-out Reports
Genetic Data Reannotation as a Service
Can we help you reannotate genetic data with our real-time, updated databases and literature investigations?
Example of Our Disease Experience
- Atypical Hemolytic Uremic Syndrome (aHUS)
- Antiphospholipid Syndrome (APS)
- Coagulopathy defects
- Complement-mediated Disorders
- COVID-19
- Dysfibrinogenemia
- Hemophilia
- Heparin Allergy (HIT)
- Idiopathic Thrombocytopenia Purpura (ITP)
- Platelet Aggregation Defects
- Platelet Defects
- Storage Pool Defects
- Age-related Macular Degeneration
- Alport Syndrome
- Cancer
- C3 Glomerular Nephritis (C3G)
- Chronic Kidney Disease (CKD)
- Duchenne’s Muscular Dystrophy
- Focal segmental glomerulosclerosis (FSGS)
- Hemophagocytic Lymphohistiocytosis (HLH)
- Polycystic Kidney Disease (PKD)
- Thrombotic Microangiopathy (TMA)
- Thrombotic Thrombocytopenic Purpura (TTP)
- von Willebrand Disease
Our Work in the Scientific Literature:
Chertow, GM. Et al. Study Design and Baseline Characteristics of the CARDINAL Trial: A Phase 3 Study of Bardoxolone Methyl in Patients with Alport Syndrome.
Am J Nephrol 2021;52:180–189.
Godara, A. et al. Use of Eculizumab in Transplant-Associated Thrombotic Microangiopathy in a Patient With Polycystic Kidney Disease Immediately Post–Kidney Transplant: A Case Report Author links open overlay panel.
Kidney Medicine 2020;2(5):652-656.
Tao J. et al. A rare case of Alport syndrome, atypical hemolytic uremic syndrome and Pauci-immune crescentic glomerulonephritis.
BMC Nephrology. 2018;19:355.
Challenge Us.
Click here to see examples of our Innovative Trial Solutions that we have created for clients.
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