MCRA is a customer-centric, full service CRO generating evidence through our specialized investigator network. Our CRO team has the expertise and experience in planning and executing medical device clinical trials across the United States and Europe. Our team has a proven track record with single-center, first-in-human, feasibility, multi-center, pivotal, and post-market trials that ensure patient protection and regulatory compliance through clinical monitoring, auditing, training, project management, and safety monitoring.
Contact an IVD Device CRO Expert
IVD Device Experience
Our CRO enables medical and IVD device companies of all sizes to successfully execute clinical studies by streamlining the clinical trial process through an integrated approach that guides clients through the medical device lifecycle. Key areas of IVD experience include:
- Anemia in vitro diagnostics
- Antimicrobial resistance marker genetic in vitro diagnostics
- Antimicrobial susceptibility (AST) in vitro diagnostics
- Autoimmune disorder in vitro diagnostics
- Bacterial infection in vitro diagnostics
- Blood clotting disorder in vitro diagnostics
- Breath in vitro diagnostics
- Cancer in vitro diagnostics
- Cancer monitoring in vitro diagnostics
- Cancer Predisposition Risk Assessment in vitro diagnostics
- Cardiovascular disease in vitro diagnostics
- Chemistry analyte in vitro diagnostics
- Companion Diagnostic (CDx) in vitro diagnostics
- Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection in vitro diagnostics
- Diabetes in vitro diagnostics
- Digital Pathology in vitro diagnostics
- Drugs of abuse in vitro diagnostics
- Fever-causing infection in vitro diagnostics
- Food and other allergy in vitro diagnostics
- Fungal infection in vitro diagnostics
- Gastrointestinal bleeding in vitro diagnostics
- Gastrointestinal pathogens in vitro diagnostics
- Gene expression profiling in vitro diagnostics
- Gene expression profiling test system in vitro diagnostics
- Genetic health risk (GHR) in vitro diagnostics
- Heavy metal in vitro diagnostics
- Immune deficiency in vitro diagnostics
- Immunoglobulin light chain amyloidosis in vitro diagnostics
- Immunohistochemistry (IHC) in vitro diagnostics
- In vitro diagnostic instrumentation
- In vitro diagnostics supported by over the counter (OTC), point of care (POC), or CLIA waiver studies
- Infectious disease in vitro diagnostics
- Latent viral infection in vitro diagnostics
- Liquid biopsy in vitro diagnostics
- Medical Countermeasure in vitro diagnostics
- Minimal Residual Disease (MRD)/tumor burden in vitro diagnostics
- Neural tube defects in vitro diagnostics
- Next generation sequencing based tumor mutation profiling in vitro diagnostics
- Organ damage/disfunction in vitro diagnostics
- Pharmacogenetic/Pharmacogenomic in vitro diagnostics
- Postnatal chromosomal copy number variation detection in vitro diagnostics
- Primary hemostatic function in vitro diagnostics
- Respiratory pathogens in vitro diagnostics
- Semen analysis in vitro diagnostics
- Sepsis and septic shock prognosis in vitro diagnostics
- Sexually transmitted disease in vitro diagnostics
- Specimen collection devices
- Therapeutic Drug Monitoring (TDM) in vitro diagnostics
- Traumatic brain injury (TBI) in vitro diagnostics
- Viral infection in vitro diagnostics
- Women’s health in vitro diagnostics
CRO Services
MCRA’s CRO team has accessibility to first-class facilities/equipment and dedicated consultants to support advanced IVD devices’ expedited route to market.
Our comprehensive CRO services include:
- 510(k) Clinical Studies
- IDE Clinical Studies
- IND Clinical Studies
- PMA Clinical Studies
- De Novo Clinical Studies
- Retrospective Clinical Studies
- Clinical Database Selection
- Clinical Research Compliance
- Clinical Study Closeout
- Clinical Study Logistics
- Clinical Study Planning and Clinical Protocol Development
- Clinical Site Budget Development
- Clinical Trial Agreement Template Development
- Clinical Trial Agreement (CTA) Negotiation
- Clinical Trial Reimbursement Services
- Clinical Trial Vendor Management
- Data Management (DM) and Biostatistics (BS)
- Database Development and User Acceptance Testing (UAT)
- Data Safety Monitoring Board (DSMB)
- Clinical Events Committee (CEC) Meeting Services
- Electronic Case Report Forms (eCRF)
- FDA Audit Preparation
- Investigator Identification
- Investigator’s Meetings (IM) and Study Kick-off Meetings
- Investigator & Study Coordinator Training
- IRB Oversight and Management
- Local & Central IRB Informed Consent Form (ICF) Template Development
- Medical and Scientific Writing
- Remote Site Management
- Remote Source Data Verification (SDV)
- Safety Management
- Site and Sponsor Audit Preparedness
- Site Selection and Qualification
- Site Administrative Payment Management
- Statistical Analysis Plan (SAP) Development
- Statistical Programming
- Study Start-up
- Trial Master File (TMF) Set up, Maintenance, and Archival