CLINICAL AFFAIRS 

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

  • Clinical protocols

  • 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