A full-service CRO that delivers to your expectations
Medical, Safety, & Writing Services
Medical and Safety Monitoring
Advanced Clinical’s Medical and Safety Monitoring team manages the daily medical activities associated with the conduct of a study, including:
- Communicating with the Investigative Sites
- Project specific and therapeutic area training to Advanced Clinical team members
- Review of safety and I/E criteria
- Fielding medical related site questions
- Protocol deviation review and management
- Oversight of safety in the study and continual evaluation of safety data
- Medical oversight and evaluation of SAEs
- Review and development of narratives for SAEs
- Review of coding and safety data listings and tables
Our services include the flexibility to use customized case processing and reporting utilizing a vendor or Sponsor’s reporting system. Our risk management activities include trending and signal analysis and benefit/risk analysis.
Our team averages 10 years of industry experience and has vast knowledge of document types and regulatory guidelines. Advanced Clinical also has expertise in ARISg, AERS, ARGUS, and other safety databases.
Our medical writing team is well-versed in preparing protocols and CSRs as well as a variety of other reports and articles. Our Medical Writers work collaboratively with the other functional areas, including the Medical Monitor, to ensure accurate and detailed deliverables are prepared. Each version of the CSR will be processed through an internal QA to ensure high quality.
The Advanced Clinical Medical Services team is overseen by our Senior Director, Safety and Medical Monitoring. Our Senior Director worked in the industry for over 25 years and holds a medical license. He has worked as a research physician early in his career and has held multiple positions with CROs and Pharmaceutical companies managing and overseeing SAEs reporting and medical scientific affairs, and has supported over 75 clinical trials across a variety of indications.