| The DCRI Safety Surveillance group represent
decades of experience in clinical research and safety reporting.
They join clinical and pharmacological expertise with extensive
knowledge of regulatory requirements and processes to provide
our clients with unparalleled speed, efficiency, and thoroughness
in reporting adverse events (AEs).
The Safety Surveillance group provides full service safety
reporting services, including serious AE data receipt and
cleaning, database creation and maintenance, coding, narrative
writing, investigator notification, medical monitor review,
and reporting to regulatory agencies.
Safety Surveillance is involved in all stages of a research
project, providing expert input in the design of key trial
documents and processes. This ground-floor approach means
that AE collection and reporting issues and procedures have
been addressed thoroughly and incorporated into the trial
design and implementation.
Throughout the life of a trial, Safety Surveillance can create
tailored tools and resources to address any safety issues
that arise, from briefing site personnel on reporting requirements
to the design and maintenance of customized databases. These
tested, successful methods translate into fast, accurate,
and thorough AE reporting and reliable regulatory compliance.
DCRI Safety Surveillance medical monitors are practicing
physicians working in academic, clinical, and research roles.
They combine clinical experience with regulatory and research
expertise for a comprehensive and relevant safety data review,
evaluation, and consultation.
Leader: Lynda Szczech,
MD
Contact: Cindy Gordon,
RN |
