ProHelix Clinical offers a fully compliant and high-quality pharmacovigilance services acting as a one-stop solution to handle your PV needs. Our mission is to help our customers to meet the strict regulatory requirements in order to maximise product potential ensuring patient safety. ProHelix Clinical has team and expertise of handling the activities for the setup and management of an effective and efficient pharmacovigilance system. We offer a range of cost-effective solutions for pharmacovigilance as well as related services in product safety.

We offer a complete range of Pharmacovigilance services as following :

• Set up and implementation of Pharmacovigilance System
• Pharmacovigilance Consultancy and Project Management
• Reporting and Assessment of Adverse Events and Serious Adverse Event
• Medical evaluation of Pharmacovigilance data and Signal Detection
• Writing Periodic Safety Update Reports
• Audits on Pharmacovigilance Systems and Pharmacovigilance Quality Assurance
• Serious Adverse Event Case Processing and Follow-up reports
• MedDRA coding
• Case Narratives
• Signal Detection & Evaluation
• Reconciliation of Serious Adverse Events
• Risk Management