Areas of Expertise
Drive Phase PV offers pharmacovigilance support at all stages of clinical development. Phase 1 may often be referred to as ‘Safety Studies’ but PV doesn’t end there and getting it right at this early stage can reap dividends further down the line in terms of speeding up time to market.
Whatever your company’s development strategy, we can develop and maintain a PV system that is unique to you and your goals.
Below are just some of the services we offer. Contact us to discuss what we can do to help you.
audit
Providing support on all aspects of audit and CAPA close-out. From routine PV system audits to inspection readiness activities, affiliate or third-party PV audits, we provide an experienced eye to ensure systems are working to both company SOP and in regulatory compliance.
periodic reports
Extensive experience in authoring and submitting DSURs to global authorities. Full document development, including QC and medical review, or ad hoc support with specific sections or workload peaks available.
Signal Detection & RISK MANAGEMENT
Continuous signal detection/safety review through clinical trials and pro-active risk management are vital to the maintenance of the benefit-risk profile of a product. A well run signal detection and risk management system can anticipate and preempt the requests of regulators and accelerate the licence application process.
Training
PV training for PV groups, investigators, sites etc. In addition we passionately believe that patient safety is a company-wide activity and provide cross-functional training to optimise PV processes.
sdeas
With ever more complex interactions between organisations involved in the development and delivery of pharmaceutical products, it is vital that every party is clear on their PV responsibilities. We author, review, implement and maintain agreements, to ensure our clients retain robust safety data collection processes.
eudravigilance & Article 57
Certified user of the R3 compliant Eudravigilance database, and Article 57 database. We can set up, manage and maintain your Eudravigilance activities, or provide additional support and training to your users.
sops & Process Optimisation
Whether setting up a new system or looking for a 'health check' on an existing one, we provide new SOP writing services as well as GAP analysis, optimisation and implementation.
We work closely with you to make processes compliant with regulatory requirements and, most importantly, practical for your ways of working.
literature screening
We provide global literature screening to support periodic report writing and signal detection and validation activities. From designing and validating search strategies to conducting searches, we provide effective and efficient solutions to this labour intensive activity.
Safety Database
Set-up and configuration of safety databases, migration of legacy cases and continuous oversight and management. We can support existing systems or provide a database directly from trusted partners.