AptivExpress™

AptivExpress™ the EDC Platform For Medical Device Trials

A web-based EDC platform that is fast, cost effective and gives you more control over your study. Your study can be built up to 75% quicker than with a traditional EDC system, often in days or weeks, rather than in months.


AptivExpress
AptivExpress is an easy to use, fully integrated software suite specifically designed to be cost effective for most medical device trials. It is a validated, CRF 21 Part 11 compliant system that includes electronic data capture (EDC), electronic patient reported outcomes (ePRO), randomization, dictionary coding, live reporting, and more.

Features

  • Faster study build and deployment
  • Lower costs
  • Data ownership
  • Greater flexibility
  • Easier use for investigators and sites
  • Regulatory compliance

Benefits

  • Simple yet powerful configuration tools allow us to develop and configure your unique study design. Using automated and customizable templates, your study can go live in as quickly as a few days or weeks.
  • Save time and money by eliminating the need for complex programming and additional IT infrastructure.
  • Maintain complete control of your data. Real-time, on-demand, standard and custom reports, and a configurable data export tool, give you the power to easily interact with your data.
  • Manage an EDC, paper or hybrid study all within the same study design. The key functionality included to support a paper study is the availability of double data entry and the generation and tracking of data clarification forms (queries) with standard reporting surrounding these activities.
  • Intuitive data entry makes it easy for physicians and site coordinators who may not be experienced in clinical trials. Instinctive, user-friendly, and highly dynamic workflows reduce site burden and promotes clean data. The system requires minimal training and is designed to allow for seamless navigation for all users.
  • The system supports compliance with 21 CFR Part 11 and HIPAA requirements. Examples of controls include electronic audit trails, electronic signatures, data encryption, access restrictions to Protected Health Information (PHI), and standard operating procedures (SOPs) that protect data confidentiality and integrity.