Medical Monitoring and Safety

PSC Clinical’s medical monitors provide expert assistance in all phases of a trial working closely with the sponsor and clinical site.  Our medical monitoring team, comprised of an expert group of licensed physicians, also specializes in conducted studies in Latin America and across the world.

Our experienced team of medical monitors aims to:

Protocol Development and Design

Guide and support the preparation, initiation, and execution of study protocols
Ensure compliance of study documentation with project plans, federal regulations, GCP, and good medical practice
Design medically accurate informed consent forms for participants
Advise on laboratory and clinical supplies requirements to Project Management, Clinical Operations, and other groups

Provide Trusted Medical Consultation

Review key documents, like protocols, case report forms (CRFs), clinical study reports, data analyses, and regulatory submissions
Continually assess the benefits and risks involved in continuation of the study.

Promote Safety

Analyze and report serious adverse events
Track safety of participants throughout the trial
Identify and evaluate safety signals, events, and trends

Training
Develop a training program according to your specific needs
Basic and advanced GLP and GCP training programs and workshops
Webinars