“Your team was very helpful and professional and I would gladly use your services again.”
Clinical Research Associate
Clinical Research AssociateTop 10 Pharma
About VCS > Virtual Safety Delivery
Virtual Safety Delivery
Safety Management Center
Secure... Trackable... Instantaneous...
Today, most Drug Safety and Pharmacovigilance managers are under pressure to improve their processes while reducing departmental costs. However, any delay in Serious Adverse Event (SAE) reporting can have severe repercussions both for patient safety and company reputation.
More than in the past, organizations are being required to automate the distribution of clinical safety reports and other clinical documentation to Investigators, central IRBs, ethics committees, stakeholders and regulatory authorities.
The 21 CFR Part 11 compliant Safety Management Center instantaneously distributes clinical safety reports, such as SUSARS and aggregate line listings, to investigators and other stakeholders. Our system follows regulatory guidelines for delivery & confirmation reporting, and reduces the costs associated with overnight shipping, tracking receipts or follow up phone calls to the sites.
The Challenge:
The procedure for reporting Serious Adverse Event (SAE) is based on multiple exchanges of information between sites and sponsors, possibly in global locations, in different time zones, and delivered in different languages.
Exchanging information within the international environment is complicated and requires significant labor and time. If not met, expedited delivery requirements for the sponsor to report the event to the study investigators can increase the risk to other study patients and result in sponsor liability.
The Solution:
VCS Safety Management Center
- Reduces the time frame for notification from days to minutes
- Reduces risk for both patients and sponsors
- Ensures compliance with FDA and ICH regulations
- Reduces delivery costs of safety reports
- Reduces heavy workload associated with tracking and follow-up
- Leverages best-of-breed tools and state-of-the-art technology