Our Services and Methodology
Our team of Drug Safety Associates (DSAs) provides clinical safety and pharmacovigilance support for biopharmaceuticals throughout the product life cycle. Our team has experience in all clinical phases including pre and post-marketing safety surveillance, observational studies, and registries. We’ll help you navigate the early steps and set a course for success.
Our clinical safety services include serious adverse event report (SAE) processing, narrative writing, coding, safety database and clinical database reconciliation, analysis of previously reported similar adverse events; and generation of Investigational New Drug (IND) safety reports, Investigator Alert Notification Letters, and annual IND update reports (safety section). Our post-marketing safety surveillance services include adverse event report case management (receipt, tracking, data entry, assessment, coding, and follow-up); electronic submission of individual case safety reports to regulatory authorities; literature review for reports of adverse events; aggregate reporting; and signal detection.
Our medical monitors are health care professionals with extensive experience in clinical research. They oversee the safe conduct of clinical studies, which includes developing medical monitoring plans; training study coordinators and investigators on adverse event and serious adverse event reporting; responding to site inquiries regarding the protocol, patient eligibility, and discontinuation issues; and reviewing reported adverse events and serious adverse events, laboratory results, and concomitant medications to identify any safety signals, trends, or concerns. Our medical monitors also participate in safety review board meetings and advise sites, sponsors, and the clinical trial team on trial-related medical questions or problems.
Our medical communications team provides flexible and scalable support in a wide variety of therapeutic areas during the prelaunch, launch, growth, and mature phases of the product life cycle. Our medical information specialists respond to inquiries from health care professionals and consumers, develop standard response letters to frequently asked questions and customized responses to specific questions, receive and triage adverse event and product complaint reports, and support medical science liaisons and sales representatives.
Work with us. Contact us to learn how we can find the right solutions for all of your clinical research needs.