Ensuring subject/patient safety and compliance with the requirements of a clinical trial protocol are paramount to the success of a study meeting its intended objectives. Therefore, it is critical to have experienced clinical and medical oversight throughout the design, execution and reporting throughout all phases of a clinical program.
Our experienced Medical Monitors are available to provide strategic drug development guidance, as well as to review key study documents and safety information and act as the lead medical resource to support the investigators and sites involved in the study.
Veristat has a network of Medical Doctors (MDs) that are available to provide 24/7/365 medical oversight of ongoing trials across a wide range of therapeutic areas. Our medical monitors offer the following clinical trial oversight, strategic consulting and safety support including:
- Designing the full clinical development plan inclusive of Protocol/Program Design & Execution, Indication selection, incorporating “Quick to POC” and commercial considerations
- Providing medical review and input into key study documents, such as protocols, case report forms, clinical study reports, data analyses, and regulatory submissions
- Acting as the main point of contact for Principal Investigators (PIs) and sites to assess patient eligibility and ongoing protocol/management issues
- Reviewing all Serious Adverse Events (SAEs) and safety information
- Recommending Key Opinion Leader (KOL) and Advisory Panel Networks
- Providing representation at regulatory meetings
