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 orthopedic device clinical trials across the United States and Europe. Our team has an excellent 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 Orthopedic CRO Expert
Orthopedic Experience
Our CRO enables orthopedic and musculoskeletal 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 experience include:
• Allografts and demineralized bone matrix products
• Ambulation
• Arthroscopy/Soft Tissue Repair
• Autografts
• Bone cement
• Bone fixation and fracture repair devices
• Bone Morphogenic Proteins (BMP)
• Bone substitutes
• Cartilage repair systems
• Cartilage resurfacing devices and products
• Growth Factors
• Hyaluronic acid
• Large and small joint replacement devices
• Ligament repair
• Limb lengthening
• Long-bone defect repair
• Orthotics and prosthetics
• Osteomyelitis and peri-prosthetic infections
• Osteoporosis
• Pain relief
• Platelet concentration
• Resorbable fixation devices
• Scaffold devices
• Small bone implants
• Soft tissue and tendon grafts
• Spinal fusion (pedicle screw systems, vertebral body replacements, total disc replacements, cervical and lumbar cages, annulus repair devices, etc.)
• Sports medicine
• Stem cells
• Surgical glues
• Surgical sealants
• Synthetic cartilage
• Trauma
• Xenografts
CRO Services
MCRA’s CRO team has proven expertise, accessibility to first-class facilities/equipment and dedicated staff to support advanced orthopedic and musculoskeletal 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