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