Rare Disease CRO
Why work with a Rare Disease CRO that is also a lab?
Our Rare Disease CRO team leverages Machaon Diagnostics’ laboratory, clinical and strategic expertise to help you unmask what are generally difficult-to-diagnose diseases. Custom-built and study-specific solutions enable us to quickly and efficiently manage a wide variety of clinical trial types.
We are happy to work with other, multi-national CROs to enhance your trial outcomes. Led by scientists and clinicians, our approach martials the latest understanding from the scientific literature, clinical practice, technology and data.
Our goal is to maximize clinical sensitivity, clinical specificity and speed.
Rare Disease defined:
a condition that affects less than 200,000 people in the US
-Orphan Drug Act, 1983
We invite you to leverage our clinical relationships with hospital systems, premiere academic medical centers, physicians and other labs, dating back to our founding in 2003.
Our Regulatory Proficiencies
College of American Pathologists
Clinical Laboratory Improvement Amendment
Good Laboratory Practices
Good Clinical Practices
General Data Protection Regulation
Yamini Bynagari, Ph.D.
Vice President of Clinical Research and Lead Scientist, Cell and Biochemical Assay Development
It starts with an Industry Leading Team
Dr. Yamini Bynagari is Vice President of Clinical Research at Machaon Diagnostics. Dr. Bynagari is an internationally recognized expert in the field of thrombosis and hemostasis. She manages the contract research organization (CRO) assay development experimental design effort at Machaon Diagnostics. Her expertise includes thrombin generation, platelet activation signal transduction and coagulation protein biochemistry. Dr. Bynagari was a joint postdoctoral scholar at Pfizer Center for Therapeutic Innovation and UCSF where she worked with Dr. Shaun Coughlin in the Cardiovascular Research Institute. Dr. Bynagari has published her research in Blood, the Journal of Biological Chemistry and the Journal for Thrombosis and Haemostasis in addition to other high-impact scientific journals. She is a peer-reviewer of Thrombosis Research, Journal of Receptors and Signal Transduction.
|BS||Ana University (India)|
|PhD||Temple University (Philadelphia)|
|Post-doctoral Scholar||Pfizer CTI|
Yamini Bynagari, PhD
8 out of 10 Largest Pharmaceutical Companies Choose Machaon
CRO and Testing United Under One Umbrella
The largest pharmaceutical companies rely on Machaon specialized laboratory expertise and clinical trial services.
- Often the Fastest TAT in the Industry
- Expansive Specialized Tests
- Lab Testing and CRO Services United Under One Umbrella
- Customer First Approach
Who Else is Choosing Machaon?
- 9 out of 10 top medical centers in the US
- 8 out of 10 largest global CROs
Our Business Process
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
Example of Our Disease Experience
- Atypical Hemolytic Uremic Syndrome (aHUS)
- Antiphospholipid Syndrome (APS)
- Coagulopathy defects
- Complement-mediated Disorders
- Heparin Allergy (HIT)
- Idiopathic Thrombocytopenia Purpura (ITP)
- Platelet Aggregation Defects
- Platelet Defects
- Storage Pool Defects
- Age-related Macular Degeneration
- Alport Syndrome
- 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
Examples of 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.
Click here to see examples of our Innovative Trial Solutions that we have created for clients.
Need our expertise?
-only 3% of pharmaceutical drugs make it to market. Click here to send us an inquiry.