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