Product Overview

Promasys® is an integrated clinical data management and EDC system that brings industry standard quality and efficiency to the data collection and data management in your clinical trials. Built on a history of innovation spanning 25 years and utilized in over 1000 clinical trials around the globe, Promasys has become the leading data management and EDC solution of choice to many of the world's leading academic, medical research and life sciences organizations.

“CHDR performs perhaps the most complicated pharmacokinetic-dynamic studies in the field and our studies produce a data flow that would be unmanageable without this system (Promasys). The change to the iPad product leads to immediate and considerable savings in staff costs that easily outweighs the acquisition cost. The smooth workflow from design of the database to the final publication is another feature we could not do without.” Adam Cohen, M.D., Ph.D., Professor of Clinical Pharmacology and CEO, Centre for Human Drug Research

Efficient

Streamlining and increasing the efficiency in the clinical data management, data capture and reporting process is a cornerstone of Promasys. From end to end Promasys was developed to increase the speed of study start-up and data capture while virtually eliminating the need of IT or programming skills. Promasys is focused on ensuring high data integrity and quality controlled clinical trial conduct.

Mobile EDC

Promasys features an innovative iPad compatible EDC that brings secure mobile data entry and subject management to the clinical trials work floor. The Promasys iPad app delivers Promasys’ featured support for data quality and integrity and regulatory compliance on a mobile device, making it easier for research nurses and study investigators to enter and review data while at the point of care. Study monitors also benefit from the mobile capability of the Promasys iPad app: when doing source document verification tasks at the study site they can review the data in the database (with read-only access), look at the audit trail information of data items, raise and review queries and sign off data for review.

Flexible

Resource limitations pose a significant challenge for investigator initiated trials. Promasys is designed to meet these unique requirements. Protocol amendments and mid-study changes are efficiently and quickly applied, and consistency between the data capture tools and the database are always ensured. Promasys provides the right balance between control and flexibility.

Benefits

  • Affordable and versatile: efficiently run high quality clinical trials with maximum cost efficiency
  • Fast study build, no programming required; copy complete study design or just individual design items from templates or other studies; easily exchange study design between Promasys users (send as email attachment)
  • Set and forget access control; compliance with rules and regulations (GCP) ensured by the Study Life Cycle™, Promasys’ built in quality control engine; full audit trail on data items and on study design
  • The Promasys iPad app: fully functional, multilingual mobile EDC out of the box
  • Supports paper based trials with double data entry, paperless trials with full electronic data capture, or hybrid studies
  • Promasys gives the investigator ownership of the clinical trial data while maintaining data integrity: data of all studies in Promasys remain always accessible for review and export