Bring life-enhancing therapies to market faster, safer, and more efficiently

Every day, every document, and every dollar matters when you’re in the business of solving the world’s most pressing health care challenges.  You need more than just compliance — you need streamlined, collaborative processes, from testing and quality control to customer relationship management, sales and distribution.   

Aurea Life Science Solutions give you a purpose-built platform designed to maximize revenue, minimize risk, and create more collaborative, profitable relationships with your researchers, partners, regulators, and customers. 

With Aurea Life Science Solutions, you can: 

  • Simplify, streamline, and automate clinical trial processes via a collaborative platform
  • Ensure product quality with a closed-loop system for managing deviations, complaints, audit findings, change control, and CAPA. 
  • Manage regulatory compliance and submission documents throughout the life cycle using a single, organized, and compliant system 
  • Create truly collaborative team and customer relationships, for smarter collaboration and stronger engagement

Clinical Document Management

Regulatory Document Management


Customer Relationship Management

Manage Trials, Not Paperwork

Managing essential trial documents on paper is a hassle, and as clinical trials become more global, it’s only getting worse. 

With Aurea Life Sciences solutions, you can easily deploy, manage, and track your critical trial documents from anywhere in the world, allowing you and your investigative sites to efficiently manage inspection-ready Trial Master Files. 

With Aurea Life Sciences solutions, you can: 

  • Standardize documents and processes
    Drastically reduce the time wasted processing documents, and ensure higher quality throughout the trial master file. Our system enforces your business processes throughout the trial by using metadata, auto-naming rules, duplicate document identification, and automatic indexing. 
  • Gain visibility into ETMF health
    Stop waiting until the study ends to see what’s missing. With built-in document checklists and milestone tracking, you can quickly and easily assess the completeness and compliance of each trial site file. 
  • Collaborate with trial site staff and partners
    Improve document quality, communication, and collaboration with your investigators and other partners through a simple, easy-to-use interface for accessing and contributing documents. 
  • Work smarter with built-in industry best practices
    Get started with industry standard taxonomy and workflows based on the TMF Reference Model, making it even easier to configure the system to meet your unique business requirements.

Complete Life Cycle Management in a Single System

US NDAs are continuing to expand, with some containing in excess of 500,000 pages of documents and data. Add in the ever-tightening submission time frames, and the challenge of effectively managing regulatory submissions is overwhelming. 

Aurea Regulatory Document Management Solutions enable your business to manage, organize, and connect their regulatory data in a compliant, efficient, and easy to use way. Our regulatory solutions combine an end-to-end set of features, spanning the whole document lifecycle — from inception and authoring to the submission and archiving of regulatory documents.

With Aurea Regulatory Document Management Solutions, you can: 

  • Produce submission-ready documents automatically
    From flexible template-based authoring to intelligent metadata tagging, you’ll reduce redundant, labor-intensive activities and enable your group to bring content from creation to submission-ready status in minimal time. 
  • Mitigate risk and ensure compliance
    Stay fully compliant with ever-shifting regulatory landscape and global agency requirements with built-in industry standard best practices and complete configurability to your specific business rules — all based on the EDM Reference Model. 
  • Scale easier, and collaborate anywhere
    Eliminate the need for complicated IT solutions as you expand to new regions or offices. Our web-based, mobility-optimized solutions provide a single source of truth to all stakeholders, greatly increasing speed to submission. 

Completely eliminate quality and compliance issues

Nearly a third of all FDA warning letters cite a failure to create or follow rules or quality processes.  

Aurea’s Quality Management solution is designed to remove non-compliance at every step of the process — with pre-configured solutions for managing deviations, complaints, audit findings, change control, and CAPA to save your organization valuable time and money. 

With Aurea Quality Management solutions, you can: 

  • Connect the entire SOP lifecycle, from creation through distribution and beyond, with a single solution. 
  • Manage Corrective and Preventative Actions (CAPA) used in continuous improvement in quality and processes. 
  • Manage Deviations and OOS from occurrence to investigation and closure, in a fully configurable and automated fashion. 
  • Record, route and resolve customer complaints faster and more easily. 
  • Generate a complete audit trail, and track your observations, findings, and recommendations throughout  
  • Control changes or modifications to products and processes, and easily manage associated tasks. 

Create truly collaborative customer relationships

Aurea CRM for Life Sciences allows you to evolve from managing customers to creating truly collaborative relationships. Whether you sell products for prescription medicine, consumer health care, or animal health, Aurea CRM includes a wide variety of prebuilt processes based on industry best practices. 

Aurea CRM for Life Sciences lets you: 

  • Optimize key customer-related processes, such as scheduling calls, managing samples and orders including e-signature capture, creating account plans, managing KOLs, or planning events.
  • Execute processes for different sales channels, such as pharmacies, doctors, hospitals, MCOs, and more. 
  • Make accurate, strategic sales and marketing decisions with simple, structured overviews of call statistics, market trends, pipelines and forecasts 
  • See business specific, 360-degree views of your prospects and customers, including relationship networks that help you identify multipliers and depict organizational structures
  • Enable cross-functional use of CRM data with powerful connectors and extensions
  • Integrate with healthcare professional reference databases, such as OneKey™
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