Imarc
Avania is a leading, full-service contract research organization focused on managing clinical studies for medical devices, IVDs, biologics, and device-drug combination products globally. They support products from initial human trials to post-market phases, offering strategic consulting, data analytics, safety, compliance, clinical operations, and market access solutions to advance medical technology from concept to commercialization. They also provide specialized services in regulatory and medical writing, clinical evaluation, site selection, and data visualization to support the entire lifecycle of medical device development and approval, ensuring compliance with evolving regulations such as MDR and MDR-specific requirements for medical apps.
Industries
Nr. of Employees
medium (51-250)
Imarc
Strongsville, Ohio, United States, North America
Services
Regulatory and clinical strategy, gap analyses, product development planning, and preparation of regulatory interactions to advance medical technologies from concept to commercialization.
Statistical consulting, data analysis, safety reporting and medical device reporting support, and data strategy for regulatory submissions and reimbursement dossiers.
Full-service clinical operations including site feasibility, initiation, monitoring (on-site and remote), data collection oversight, and centralized imaging core lab services.
Payer strategy, CMS/Medicare IDE coverage support, reimbursement submissions, and assistance with national prostheses lists and reimbursement item selection processes.
Preparation and management of regulatory dossiers and interactions for FDA and EU Notified Body submissions, including pre-submission planning and response management.
Independent evaluation of EDC platforms, build and configuration, integration of ePRO/eConsent, and compliant data workflow design.
Regulatory and clinical strategy, gap analyses, product development planning, and preparation of regulatory interactions to advance medical technologies from concept to commercialization.
Statistical consulting, data analysis, safety reporting and medical device reporting support, and data strategy for regulatory submissions and reimbursement dossiers.
Full-service clinical operations including site feasibility, initiation, monitoring (on-site and remote), data collection oversight, and centralized imaging core lab services.
Payer strategy, CMS/Medicare IDE coverage support, reimbursement submissions, and assistance with national prostheses lists and reimbursement item selection processes.
Preparation and management of regulatory dossiers and interactions for FDA and EU Notified Body submissions, including pre-submission planning and response management.
Independent evaluation of EDC platforms, build and configuration, integration of ePRO/eConsent, and compliant data workflow design.
Expertise Areas
- Clinical trial management
- Early feasibility studies (EFS) and first-in-human trials
- Adaptive trial design and statistical planning
- Biostatistics and data analytics
Key Technologies
- Electronic data capture (EDC) systems and integrations
- ePRO and eConsent integration
- Cloud-based clinical data analytics
- Adaptive trial statistical methods and interim analysis
News & Updates
A detailed event on strategies for market access and reimbursement in the MedTech industry.
White paper discussing FDA's new regulations for laboratory developed tests.
White paper on the role of imaging core labs in medical device research.
White paper on clinical trials in oncology using core labs.
A detailed event on strategies for market access and reimbursement in the MedTech industry.
White paper discussing FDA's new regulations for laboratory developed tests.
White paper on the role of imaging core labs in medical device research.
White paper on clinical trials in oncology using core labs.