Clinical Research Consultants provide expert planning, management, and preparation of clinical studies. The team is experienced in clinical trial design, study management, monitoring, and statistical analysis for both pre-market and post-market studies. We supplement our expertise by working alongside expert medical and statistical consultants whenever the need arises. We work hard to be both efficient and cost-effective for our clients.
Preparing Study Materials
Case Report Forms
IRB submission materials and informed consent documents
Study handbooks and Investigator Agreements.
Managing and Monitoring Trials
Identify and evaluate potential sites/investigators
Provide liaison with IRBs and FDA
Conduct investigator meetings/train site personnel
Monitor/audit sites to verify protocol compliance
Providing Data Management and Statistical Analysis
Database and data entry screen design
Data Quality Control, coding, entry, and verification
Statistical analyses and clinical report preparation