Leading technological innovation
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 The pharmaceutical industry is still largely relying on established, but increasingly outdated, systems and methodologies that were efficient many years ago yet now prove to be a limiting factor in innovation and growth.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.
Most pharmaceutical companies have the raw ingredients at their fingertips – mass volumes of valuable historical data that can be analyzed to predict future outcomes. At PharmaLex we have the technology, know-how and experience to take these raw ingredients and realize real, immediate and lasting benefits for our customers – we call this Knowledge. Accelerated. Some examples of software enabled service portfolio below.
SmartPHLEX combines expert knowledge and new technologies
What our intelligent systems can do for you?
- Record and automate current workflows
- Use bots to support human experts with repetitive tasks
- Monitor bot and people performance, capturing & sorting data
- Automatically extract data from SmPCs and enter into the Regulatory Information Management system
- Intelligent drafting of documents
- Automate process and transfer information between systems to connect silos
- Minimize human efforts on regulatory dossier compilation
- Automatic and intelligent compilation of dossiers
- Advanced pharmaceutical analytics to shape future decision making
- Advanced collaboration with chat-based technology
- GxP management – orchestration of all global Pharmacovigilance activities within a single cloud solution integrating to existing safety databases and tools
- Pharmacovigilance case processing – automated processing and audited screening of incoming E2B(R3) case safety reports for both L2A and MLM scenarios
- Pharmaceutical literature screening – automated monitoring of safety literature outputting CIOMS or E2B compatible safety reports in a quality assured environment
- Contracts/Agreements – efficient cloud-based management of Pharmacovigilance agreements ensuring all party compliance with safety obligations
- Holistic solution for automation of regulated processes enabling fast, cost-effective and compliant transition to paperless quality and compliance
- Risk Assessment Tool for Excipients (RATE)
- Vendor Metrics – compliance management and risk assessment of GXP vendors
- Regulatory Intelligence – customized data management solutions and services for Regulatory Intelligence throughout the full product lifecycle
- Regulatory Operations – expert support and industry partnerships for selection, implementation and operation of end-to-end regulatory systems landscapes including Regulatory Information Management, publishing and archiving
- Patient Information Management – innovative process automation platform for ensuring global continuity and compliance of patient information and labeling documents for both innovator and generic products
- Redaction – efficient and compliant anonymization of trial data and documents
- Early Stage Clinical Research – advanced research analytics, insights and statistics as they happen
What our clients say
Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.
Head of Medical Writing and Publications
We really appreciate your responsiveness and availability during our previous exchanges and it is what we are waiting for from our partner.
Head of Regulatory Affairs