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 a DEntal CRO Expert
Dental Experience
Our CRO enables medical and dental 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:
- Additive Manufactured Dental devices (e.g., customized Implants, Crowns, Plates, Dentures, Restorations etc.)
- Bone Grafts
- Bone Substitutes
- Dental Abutments
- Dental Amalgams
- Dental Cements
- Dental Combination Products
- Dental Imaging Equipment
- Dental Implants
- Dental Membranes
- Dental Plates
- Intraosseous Fixations
- Lasers
- Mandibular Condyle Prostheses
- Maxillofacial Reconstruction Implants
- Orthodontic Appliances
- OTC Denture Cushions
- Total Temporomandibular Joint Prostheses
- Transmandibular Implants
CRO Services
MCRA’s CRO team has accessibility to first-class facilities/equipment and dedicated consultants to support advanced dental 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