Services: Clinical Research Organization
We tailor our full service CRO capabilities to accommodate budget and timeline requirements for small feasibility studies, usability studies, clinical performance or marketing studies, and multicenter pivotal studies to support PMAs. We have experience conducting clinical trials with international companies, with clinical sites in the US, Canada, Brazil, Mexico and the EU. We have also managed Post Market Clinical Followup (PMCF) studies to support CE marking. Our services also include study design, statistical analysis plan creation, and data analysis and reporting.
Clinical Research Organization Services offered by M Squared Associates includes:
- Protocol Development
- Biostatistics
- Statistical Analysis Plan
- Data Analysis and Reporting
- IRB Submissions
- Clinical Trial Agreement and Site Budget Negotiations
- Essential Document Creation
- Trial Master File Management
- Clinical Study Management and Monitoring
- Investigational Site Qualification and Site Initiation
- Investigator and Investigational Site Staff Training
- Quality audits
- Site and Sponsor Support, FDA Bioresearch Monitoring Audits
- Subject and Study Site Payment Management
- DSMB or Medical oversight