Digital Innovation
Improve compliance, speed to market and quality with PharmaLex’s advanced software and technology-elevated services
Digital Innovation @ PharmaLex
Where Expertise Meets Innovation
Improve compliance, speed to market and quality with PharmaLex’s advanced software and technology-elevated services
Broad and Deep Life Sciences Expertise Coupled with Innovative Technologies Delivers Elevated Business Value
Innovation truly is in our DNA. It’s our core expertise that differentiates our approach to innovation, and ultimately how we revolutionize the Life Sciences industry by working hand-in-hand to see what others do not, and developing new technology-based ideas and applications.
PharmaLex is at the forefront of today’s technology revolution. We help customers evaluate, implement, and effectively utilize innovative technologies to dramatically improve quality and efficiency across companies’ business operations.
We combine extensive global experience and deep understanding of pharmaceutical product lifecycle and processes with the latest technology. We’re helping pharmaceutical companies turn untapped data and legacy processes into lasting value.
Use Case
Technology-Enabled Regulatory Operations – PhlexRIM offers cloud-delivered modular capabilities for Regulatory Operations
- Enables fast and reliable regulatory submission creation using industry-leading document and submission management solution
- From medical writing to regulatory submission to registration management, PharmaLex offers the full spectrum of capabilities to clients of all shapes and sizes
- Innovating new approaches to ensure timely delivery and high-quality results
Use Case
AI-Powered TMF Document Submission and Classification – Market-leading PhlexTMF SaaS offering & full-service provision
- Electronic Trial Master File (eTMF) system pre-trained on millions of TMF documents and embedding the cumulative guidance of hundreds of TMF experts
- AI driven software provides suggestions immediately after a document is uploaded to the eTMF, helping to ensure clinical documents are “right-first-time” at the critical document upload stage
- Reduces misfiles and metadata errors to improve TMF quality, lower inspection risk, and prevent time-consuming remediation
Use Case
Centralized regulatory intelligence for Safety Letter Distribution – psiXchange entirely automates the complex distribution process for your critical safety documents.
- Allows sending of any business-critical safety document to any recipient – ensuring acceptance
- Seamlessly connects to data sources including ArisG LifeSphere, Oracle Argus, AB Cube Safety Easy
- Intelligently manages contact lists in any CTMS or within psiXchange Clinical Trial module
- Ability to manage reporting requirements within platform – including cross-reporting and retrospective reporting
- Delivery according to exact recipient preference (e-mail, fax, download link, courier, smart portal)
- Innovating new approaches to ensure timely delivery and high-quality results
Use Case
Comprehensive automated statistical report writing – SmartStats offers multiple modules that facilitate report writing in line with guidelines and health authority expectations.
- Standardize reporting across the organisation
- Up-to-date with latest authority requirements (EMA, FDA, …)
- Suitable for GxP use (GAMP5 validated, 21 CRF Part 11 compliant)
- Save cost and time in report writing
- Significantly reduce human errors
- Go further than Excel (e.g. REML, quantile computation, etc.) to always give exact statistical results
- Developed by statisticians for non-statisticians
Discover How PharmaLex Digital Innovation Can Support your Compliance Goals
Regulatory
Safety
Quality
Statistics
Scientific
Regulatory
A Regulatory Intelligence system for managing officially published Health Authority guidelines, combined with our own experience and recommended best practices.
A Regulatory Information and Process Management system for managing the workflow of regulatory submissions from the planning phase through to submission and archive.
A simple to use ‘plug-in’ tool for Microsoft Word, automating selected existing document processing functionality.
An intelligent system to support the maintenance of medical product information e.g. packaging and patient leaflets.
A smart tool which assesses a company’s readiness and determines their state of compliance for the EU Medical Device Regulation effective in May 2021.
Safety
Application for processing and screening case safety reports of adverse reactions to medicinal products.
Database that tracks pharmacovigilance agreements between clients and third-parties.
A web-based solution for global and local literature monitoring and screening.
Quality
Management of data related to the use of excipients (inactive ingredients) in the manufacturing of medicinal products.
A smart tool which assesses a company’s readiness and determines their state of compliance for the EU Medical Device Regulation effective in May 2021.
Statistics
Software for the validation of physicochemical method such as LC, GC, EC, AAS, titration, UV.
Software dedicated to the evaluation of the long-term stability of your product and to the determination of its shelf life.
Software dedicated to the validation of bioassays such as ELISA, RIA, parallel line, parallel curve, slope-ratio and microbiological assays, qPCR.
Software dedicated to assess if a method can be transferred from a “sender” lab to one or several “receiver” labs according to the tolerance interval approach.
Software dedicated to facilitate report generation in line with all kinds of guidelines and authority (EMA/FDA/MHLW) expectations.
Scientific
Utilizing our strategic and clinical expertise to drive efficiency gains during the earliest phase of development
PharmaLex continually engages with Key Opinion Leaders and scientific experts across the industry to identify opportunities where technology could lead to faster market approval or automated post-market surveillance. Twice nominated by CPhI for our innovative use of technology, we consider this approach to be essential in future proofing our industry.
Our PharmaLex.perts are currently working on developing a number of exciting solutions to bring cutting edge technology to early phase activities. Once tested we will launch them here, so watch this space!
Resources
Whitepaper:
What is preventing us from providing electronic product information and how industry can support the wider ePI project?
Survey:
Disruptive Technologies in Life Sciences (DTLS) consortium – annual survey results
Ready to improve compliance, speed to market and quality with PharmaLex Digital Innovation? Contact us today
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Global Approach
PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.