The safety and efficacy of new drugs are closely monitored by regulatory agencies. Staying current with the safety and pharmacovigilance (PV) requirements, standards and safety issues is challenging, but failing to do so can introduce unnecessary compliance risks and failed submissions – ultimately wasting time, money and resources. Robust processes and monitoring are required to enable immediate action should a safety issue arise during drug development or after launch.
Clarivate’s expert consultants deliver the customized solutions you need to be confident in your PV strategy and compliance activities. Make informed decisions and improve operational efficiencies with help from our team, who applies a unique combination of data, analytics, insights and workflow tools to deliver solutions based on your specific requirements.
Get tailored solutions to support your organization’s workflows, integrate with existing systems, and deliver current, full-coverage, global safety-related regulatory information from many sources, including Cortellis Regulatory Intelligence.
Spend less time compiling information and free up resources for more strategic activities using customized and interactive PV/vigilance dashboards that include the latest intelligence on drug safety and regulatory compliance requirements. Set up customized alerts and never miss an update!
Easily understand and track updates to guidance documents, agency safety communication publications, inspections and enforcements, product safety alerts, and required safety-related actions with Regulatory Spotlight e-newsletters.
Identify current PV system gaps and apply our expert recommendations to improve compliance activities and optimize processes through safety and PV regulatory impact assessments, gap analyses, Good Vigilance Practice (GVP) audits and SOP reviews. Our team can also help you with SOP development, PV system master file (PSMF), safety data exchange agreements (SDEA) and corrective and preventive action (CAPA) management.
Have confidence in your regulatory submissions through our safety and adverse event data management services, including case management, literature monitoring, signal detection, identification of trends and analysis of similar events, data reconciliation, safety report writing and Data Safety Monitoring Board (DSMB) submissions.
Expand the scope of your vigilance team with our network of experienced, regional and national Qualified Person for PV (QPPV), Responsible Persons for PV (RPPV), Local Contact Persons for PV (LCPPV), and Responsible Person for EudraVigilance (EV).
Gain actionable insights by easily and comprehensively accessing relevant safety data from a diverse range of data sources, including information on pre-clinical toxicology data, epidemiology, biomarkers and Real World Evidence (RWE).
Rapidly review the latest relevant vigilance and safety data and regulatory information through customized dashboards. Receive answers to ad hoc queries on regulations, and perform a deep dive into relevant local regulations with ease.
Confidently interpret and implement regulatory requirements by applying experience-driven advice and guidance from our consulting team.
Make better-informed decisions using our regulatory impact assessments on upcoming regulations, identifying required actions and system changes and determining resource needs.
Achieve optimal process efficiency by applying our latest technology solutions such as artificial intelligence (AI), automation, text mining and predictive analytics algorithms in addition to our safety database management and workflow products.
Our accredited global alliance program delivers value-added solutions by combining offerings from Clarivate with other technology and service providers. Partner with us to drive profitable growth, increase revenue and deliver greater value to your customers.
Receive daily insights on the latest biopharma news and medical technology advances to better inform crucial R&D decisions at the earliest research stages.