ClinDatrix considers patient safety its highest priority when conducting clinical trials. We adhere to the strictest standards in our study conduct and provide critical expertise through the experienced MDs, led by Dr. Steve Balyakin MD and other qualified safety personnel in our Medical Safety department.
ClinDatrix Medical Monitors work in collaboration with the investigator sites as well as our internal Project Management, Clinical Monitoring and Data Management teams to provide patient safety oversight. ClinDatrix uses the Oracle Argus Safety System software to collect, monitor and manage safety data. This platform allows secure, real-time access to data and reporting tools for data through all phases of clinical research. We also offer the necessary tools and processes to address sponsors’ safety surveillance and pharmacovigilance needs.
Our Medical Monitors promote every aspect of patient safety through internal and external project teams. They can provide site education and training for a study team on medical/disease states, treatments, laboratory procedures, protocol compliance and potential study issues. Medical Monitors also assist our clients with medical data review and analysis, clinical study reports and regulatory submissions.
During clinical studies, the Medical Monitors oversee product safety, process SAE reports and generate SAE narratives.
Protocol Waiver and Compliance Assessment
The Medical Safety team monitors protocol deviations/violations. Exceptions, where appropriate, are secured through a written approval of the sponsor. Such exceptions, however, are extremely rare.
SAE Surveillance (24 hour/7 day coverage available)
The ClinDatrix SAE Reporting System uses multiple modes of communication, including telephone, FAX, e-mail and e-SAEF (electronic SAE forms completed in an electronic data capture system), to collect data regarding SAEs. Furthermore, medical consultation is available 24/7 to answer medical questions and to assist in review and evaluation of event collection and reporting.
The Medical Safety team can assist medical device sponsors with consultation services regarding investigational device exemptions (IDEs), pre-market approval of medical devices (PMAs), medical device reporting (MDR) of adverse events, medical device safety vigilance and incident reporting.
Laboratory Safety Review Including Laboratory Alerts
Our Medical Safety team is experienced in reviewing laboratory safety data and in generating lab alerts (if needed) to all investigators involved in the study. The Medical Safety team regularly monitors patient laboratory results and promptly informs the sponsor and/or investigators of any significant laboratory or clinical findings.
Our Senior Medical Officer is a certified MedDRA Coder. He provides MedDRA and WHO Drug coding in accordance with regulatory requirements.
Scientific Advisory Boards and Drug Safety Monitoring Boards
The Medical Safety team oversees the generation of medical data in the form of safety listings to be used at scientific advisory boards and data safety monitoring board (DSMB) meetings.
Working with the Data Management, Biostatistics and Clinical departments, the Medical Safety team prepares and writes Clinical Adjudication Committee (CAC)* procedure manuals, sets up and implements the data collection process for endpoint data, prepares patient reports for the CAC to be reviewed remotely and during face-to-face meetings, organizes and assists the CAC during face-to-face meetings, and tracks the endpoint adjudication status for each potential endpoint.
The Medical Safety team can assist a sponsor with the reconciliation of SAE with AE data and provide support to Regulatory Affairs. For sponsors without medical personnel, ClinDatrix can provide Chief Medical Officer services. In addition, Medical Safety can generate periodic safety reports, provide post-marketing pharmacovigilance and manage medical information and complaint reporting call centers (consumer complaint tracking and reporting) as well as provide literature review services and medical publication reviews. In addition, our Medical Safety team can be called on to assist in processing aggregate reports such as periodic safety update reports (PSURs), addendum PSURs, summary bridging reports and suspected unexpected serious adverse reaction (SUSAR) reports.
These committees also are referred to as a Clinical Event Committee or Clinical Endpoint Committee (CEC), Endpoint Validation Committee (EVC) and Clinical Adjudication Committee (CAC).