Ensure Drug Safety & Regulatory Compliance
Patient and trial subject safety sits at the heart of every life sciences firm’s mission. The Daelight team has helped some of the world’s most innovative pharmaceutical, biotech and medical device companies ensure both product safety and compliance.
Results-Focused Pharmacovigilance Consulting
At Daelight, we believe that properly functioning, compliant IT systems are critical to the efficacy of pre- and post-marketing drug safety efforts. With the right solutions and workflows in place, PV teams are at their most efficient and effective. Without them, the consequences to the business and human life can be dire.
Our team has extensive experience helping life sciences firms large and small select, implement, integrate, migrate, audit and tune pharmacovigilance platforms. We combine realistic, sustainable technology strategies with highly adept execution to deliver real-world results, swift ROI and lasting business impact. Our clients’ success is our success.
Our Drug Safety Software Expertise
Daelight’s consultants have hands-on experience in all leading PV and quality management software systems, including Pega and all editions of Oracle Argus:
- Cloud Standard
- Cloud Enterprise
- On-Premise Standard
- On-Premise Enterprise
Whatever the technology stack, our pharmacovigilance consultants bring unique expertise and methodologies to help firms:
- Select and implement the right PV system for their needs
- Develop and streamline adverse event reporting intake, workflows and case management
- Support highly scalable, end-to-end safety processes
- Ensure compliance with all relevant regulations and guidelines, including Title 21 CFR Part 11 and FAERS
- Audit cloud-based or on-premise systems for compliance and best practices
- Integrate PV solutions with complementary systems, like Registration Management and CTMS platforms
Case Study: How a pharmacovigilance health assessment helped a mid-size pharma and medical device company with Argus.