Operations
MedAvante is structured to provide our customers (i.e., Sponsors and Investigative Sites) with prompt, courteous and high quality service. Our goal of flawless execution has helped drive a process oriented culture. MedAvante has developed and continues to refine a comprehensive set of Standard Operating Procedures, project plans and templates that ensure we deliver a service of consistently high quality.
Our knowledgeable staff has deep clinical trial experience stemming from years with CROs, Pharmaceutical and Biotech companies, Research Centers and Hospitals. We appreciate the challenges that our customers face and seamlessly integrate our services to accommodate each study's unique needs.
Our focus on linking people, processes and tools has permitted MedAvante to deliver a suite of services that provide our customers with informative study outcomes. Whether we are training a site rater in the Ukraine on the SIGH-D, reviewing a recording of a Russian site rater administering the SIGH-D, or a MedAvante rater is administering the SIGH-D to a study subject in the United States, MedAvante's standardized processes and procedures ensure consistency and reliability. Our corporate operations provide:
- Patent Pending Rater Resource Allocation Systems
- Proprietary Data Collection System
- Proprietary Quality Control Assessment Tool
- Proprietary Convention Logs
- eLearning Platform
- Quality Assurance Plans
- Quality Control Plans
- Scale Specific Training & Calibration Plans
- Project Specific Documentation:
o Remote Assessment Plans
o Remote Assessment Manuals
o Investigative Site Rater Training Plans
o Work Instructions
o Rater Manuals
o Trainer Manuals
o Weekly Status Reports
Every MedAvante service has the operational structure to guarantee flawless execution.
Operational Structure
MedAvante’s centralized structure offers advanced telecommunication and automated workflow programs. Automated file management and workflow rules ensure that MedAvante’s central raters are internally monitored to the highest quality control standards and are truly blinded to patient history and study design to eliminate any rater bias. MedAvante’s expert raters are continuously calibrated to ensure the highest inter-rater reliability (above .90) throughout a study.
MedAvante recently implemented real-time electronic data capture of source documents and assessment data. MedAvante’s expert raters use a proprietary application running on tablet PC’s which streamlines data capture and storage, and prevents transcription errors. This proprietary application provides electronic exports of assessment data to the Sponsor.
Study Experience
45,000+ Number of scales administered remotely by MedAvante Clinicians
15,000+ Number of remote sessions completed by MedAvante Clinicians
300 Number of unique Investigative Sites that have participated in CR study
• 150 of those Sites have worked with MedAvante 2 – 9 times
25 Number of countries where MedAvante has delivered services
Operational Overview: Keep it Simple
| 1. | Site Set-Up | MedAvante sets up Sponsor selected Investigative Sites with VTC equipment (if applicable). |
| 2. | Schedule Assessment | Site calls MedAvante’s toll free number to schedule an assessment and site receives fax and/or email confirmation. |
| 3. | Conduct Assessment | Subject arrives at site for visit and MedAvante conducts assessment. |
| 4. | Send Results | MedAvante faxes assessment results and safety data to the site and provides electronic export of study data to the Sponsor. |