DRUG SAFETY AND PHARMACOVIGILANCE
Staying on top of drug safety.
Drug safety and pharmacovigilance professionals are increasingly challenged, having to do more with less. The key to your success is implementing automation, adopting advanced technologies, and leveraging insights from analytics that improve compliance and product safety. Haleus provides flexible, innovative, scalable solutions to meet your unique business requirements.


Comprehensive Pharmacovigilance
- Ensuring subject safety throughout all clinical trial phases and post-marketing activities
- Providing a full suite of pre-approval and post-marketing pharmacovigilance services
- Managing safety data and adverse events to minimize risks associated with clinical studies and investigational drugs
- Utilizing innovative electronic systems to enhance data accuracy and reduce inconsistencies
- Offering tailored pharmacovigilance solutions after thorough evaluation and analysis to minimize risks
Pharmacovigilance for Clinical Trials
- Managing safety databases efficiently to ensure robust data integrity
- Handling case management duties including tracking and analysis of safety reports
- Conducting medical coding for accurate categorization of trial data
- Preparing and submitting safety reports like SUSARs, PSURs, and DSURs
- Performing global literature searches and reviews to support safety assessments


Pharmacovigilance for Post-market Studies
- Detecting signals to identify potential safety issues post-marketing
- Supporting protocol development with safety data insights
- Drafting and reviewing risk management plans to ensure ongoing safety
- Screening literature for additional safety information post-launch
- Managing safety reporting for individual case safety reports and aggregate reports
Pharmacovigilance System Services
- Setting up and managing PV systems to support comprehensive safety monitoring
- Maintaining PV systems to ensure they meet regulatory and operational requirements
- Supporting system audits to validate data integrity and compliance
- Ensuring data security and safe transfer of sensitive information
- Providing regulatory support for all safety reporting needs


Support Services Outsourcing
- Writing and updating SOPs to ensure best practices in pharmacovigilance
- Delivering targeted training services to enhance team competence in safety processes
- Keeping up with regulatory updates to maintain compliance
- Conducting monitoring and audits/inspections to ensure continuous improvement
- Outsourcing system management tasks to streamline operations
PV Audits and Training
- Conducting internal audits to assess pharmacovigilance practices
- Providing training and mock inspections to prepare teams for regulatory audits
- Supporting audit and inspection readiness across the organization
- Managing vendor and affiliate audits to ensure third-party compliance


Haleus Insights Hub
Dive into the latest research, insights, and innovations with our team of experts in the fields that matter most to clinical advancement.

Request For Proposal
We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Streamline Your Drug Development with Haleus CRO Expertise