Global and local pharmaceutical industries is focusing, a shift towards improved patient safety through proactive identification of risks http://cialisfrance24.com and increased focus on safety regulations. They are increasingly looking to align global safety and regulatory strategies by integrating their regulatory and pharmacovigilance deliverables and moving towards a more proactive approach in risk identification and minimization. Additionally, monitoring social media for adverse drug reactions (ADRs) has gained a great deal of regulatory attention. This necessitates a broader framework for data gathering, comparison, and management. Companies will also have to leverage standard operating processes at the global and country level as well as across local networks, and establish accountability systems to ensure quality reports.
As your partner in ensuring patient safety, ClinSync offers end-to-end Pharmacovigilance Services for comprehensive coverage of safety operation needs. It creates a centralized pool of pharmacovigilance inputs to improve patient safety and regulatory compliance, achieve operational savings, and minimize litigation costs.
Services
– End to End case processing
– Aggregate report writing such as PSURs, PBRERs, PADERs
– Risk Management Plans & PBRER Line Listings
– Risk Evaluation and Mitigation Strategies,
– Literature screening and review
– Signal detection and management
– Company core data sheet update
– SmPC update for generic molecules
– Health authority responses as required
– Audit and Inspection support
– Developing SOPs based on good pharmacovigilance practices
– Setting up of comprehensive pharmacovigilance system
– Medical Impact Analysis
– Tailored corporate training on pharmacovigilance
– EU and local QPPV services
Oncology
HIV/ TB/ Malaria/ Hepatitis and other infectious conditions
Post menopausal women
Dermatology- Transdermal patches, Gel/ Foam/ Cream, Cumulative Irritation studies & Skin sensitization studies
Hepatic Impairment
Renal Impairment (at partner Kidney Center)
Hypogonadal studies
Contraceptive studies
Cardiovascular and Metabolic Diseases- Cardiac Failure & Diabetes