Confidence Beyond Compliance
Individual Case Study Report (ICSR) plays an important role as it acts as a source of data in pharmacovigilance processes and activities.
Reconciliation of safety cases is performed as defined in Pharmacovigilance Agreements and contracts.
PharmaLex perform safety cases reconciliations with:
- Company affiliates
- Medical Information department
- Product Complaints team
- Clinical Trials
We ensure that the reconciliation process is performed between MAH and above-mentioned parties in a periodic manner or as defined in the respective PVAs (Pharmacovigilance Agreements), Safety Management Plans and other contracts.
Automation, artificial intelligence (AI) and machine learning are revolutionizing many industries enabling increased productivity, improved quality and enhancing return on investment. The pharmaceutical industry is still largely relying on established, but increasingly outdated, systems and methodologies that were efficient many years ago yet now prove to be a limiting factor in innovation and growth. At PharmaLex we combine our extensive global experience and deep understanding of pharmaceutical lifecycle processes with the development of our cloud-based platform for life sciences automation alongside key partnerships with leading technology vendors. Through our pharma technology-enabled services we are helping our customers to adopt and take advantage of innovative technologies to drive efficiency gains within their own operations.
At PharmaLex we have the technology, know-how and experience to take these raw ingredients and realize real, immediate, and lasting benefits for our clients – we call this SmartPHLEX.
- SmartVigiscreen – managing EVWEB download cases: SmartVigiScreen is a cloud-based software solution that processes incoming ICSRs automating the analysis of company vs non-company cases and reducing screening workload significantly.
GxP validated system according to GAMP 5 guidelines and CFR Title 21 Part 11 compliant.
- SmartVigicontract – Efficient management of PV contracts: SmartVigicontract is a cloud-based software solution for pharmacovigilance teams who need to handle large amounts of data deriving from contracts, such as Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). The SmartVigicontract application serves as a single trusted source of information for generation of PVA overviews.
Safety Database: At PharmaLex our expert team in technology, consulting and operations support the entire pharmacovigilance journey including safety systems management, safety database migrations, etc.
- PharmaLex has rich experience of working on multiple pharmacovigilance databases including those of our clients. Our processors have experience processing cases on variety of safety database, standard systems like Argus/ARISg/AB Cube / Veeva / PVNet / Basecon / BPI Pheda etc. and also on custom built in house proprietary safety databases.
- For many clients, PharmaLex provide safety database solution. It has a fully validated E2B(R2/R3) compatible safety database for an end to end case processing services solution. For such customers, PharmaLex is completely responsible for the database management including provision of database, vendor management, computer system validation and change management, maintenance of configured settings (e.g. users, products), maintenance of related procedural documents. PharmaLex’ R&D Informatics team supports these activities, as well as database related user enquiries.
- Our Safety database services also includes comprehensive support during the migration process from planning to quality control. PharmaLex holds scalable resources to perform (semi)manual migrations or conducts automated migrations together with database providers.
- Safety databases are provided as part of PharmaLex’ service landscape including the provision of technology, vendor management, computer system validation and change management, maintenance of configured settings (e.g. users, products), maintenance of related procedural documents.
- Our technology services include database provisioning, database management, advanced safety data reporting, analytics and insights.
- Clinical Trial Safety Support
- CMC Services
- EU QPPV / National QPPV
- Healthcare Compliance and Medical Approval
- Literature Monitoring & Screening
- MedTech Services
- PAI Readiness
- Pharmacovigilance Consulting
- Pharmacovigilance Systems
- Quality Management Systems
- Tech Transfer / Scale-up
- Virtual Audits
What our clients say
I just wanted to let you know that the recent EU Codes webinar was excellent. Rina presented a very complex and grey topic in the most clear and digestible manner – a sign of a true expert. The questions in the Q&A were sometimes a little ambiguous but Rina gave clear and relevant answers that provided real clarity.
Medical Team Leader, Multi Tumor Franchise Roche Products Ltd
PharmaLex is dedicated to delivering a comprehensive portfolio while their modular approach allows tailor-made solutions. They acknowledge our feedback, modify their approach and adapt accordingly.