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 spine 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.
Spine 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:
• 3D printed devices
• Annulus repair
• Atlanto-cervico-thoracic fixation systems
• Bone void fillers
• Cervical interbody cages
• Combination devices
• Disc nucleus replacement
• Dura/vertebrae anti-adhesion
• Hydrocephalic shunt devices
• Instrument navigation systems
• Laminoplasty plates
• Lumbar interbody cages
• Pain relief
• Pedicle screw systems
• Reconstruction of intervertebral disc
• SI-joint screws
• Spinal fusion
• Spine surgery
• Total disc replacement
• Vertebral augmentation
• Vertebral body replacements
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