From proof-of-concept to post-marketing surveillance services, you can depend on our PV experts to efficiently work through the entire scope of Pharmacovigilance activities. We offer a high level of expertise and assist in meeting the highest standards of applicable national and global regulations.
The experts at ACL Digital can easily customize safety monitoring services to suit your specific business requirements. Most biopharmaceutical companies have distinct and demanding clinical safety requirements as per the directions of regulatory agencies. You can depend on our PV specialists who plan safety and pharmacovigilance services accordingly that fit the needs of both your product and study – we adhere and adapt to your processes and are flexible enough to do it the right way.
- SME Consulting
- Serious Adverse Event Reporting (SAER)
- Case Processing (Data Entry, Quality, Medical, Approval, Submission)
- Individual Case Safety Report (ICSR) management
- Literature Management (Local and Global)
- Aggregate Report Writing (PSURs, PBRERs, DSURs, PADERs)
- Risk Management Plan (RMP) and REMS writing
- Signal Management
- Compliance with Regulatory Agencies' requirements