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    Promasys®

An integrated clinical trial data management and EDC system

Promasys is an integrated clinical data management and EDC system that brings industry standard quality and efficiency to data collection and data management in your clinical trials. Built on a history of innovation spanning almost 30 years and utilized in more than 1,000 clinical trials around the globe, Promasys has become the data management and EDC solution of choice for many of the world’s leading academic, medical research and life science organizations.

Efficient
Streamlining and increasing the efficiency in the clinical data management, data capture and reporting process are cornerstones 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 for 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’s featured support for data quality, 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. Efficiency and error prevention are further increased by the barcode based navigation that takes the user immediately to the subject and CRF that are to be data entered. 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.
Promasys ePRO
Promasys 7.3 brings integrated ePro to the game. The Promasys ePRO Configurator allows the study designer to select a subset of data items for subject/patient direct data entry, and to enhance these data items with special attributes to make them suitable for ePRO use, like data entry time windows, notifications and use of onboard hardware such as camera, etc. Once the ePRO configuration for a study is complete and the ePRO study is published, study participants can download an (automatically generated) study-specific app to their iOS or Android device and after authentication will be guided by the app to enter information as required by the study protocol. The data itself is part of the overall study data and is subject to the same data quality requirements and checks. There is no need for consolidation between a study database and an ePro generated dataset. ePRO data is available to the study coordinators in real time.
Flexible
Resource limitations pose a significant challenge for investigator-initiated trials. Promasys is designed to meet those unique requirements. Protocol amendments and mid-study changes are efficiently and quickly applied, and consistency between the data capture tools and the database is 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’s 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
  • Promasys ePRO: affordable and fully integrated ePRO for iOS and Android devices
  • 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 remains always accessible for review and export



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Promasys Brochure 7.3 - English

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Promasys Brochure 7.3 - Japanese

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Compliance Made Easy Video

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Data Quality and Data Integrity Video

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“We look forward to working with OmniComm Promasys. Having worked with several commercial technologies over the past couple of years, we were impressed by the ease of operation of the Promasys system, and with the backing of an established company such as OmniComm we feel that Promasys will go from strength to strength.”
        — Carol Stillwell, Head of Data Management, Surrey CRC

 


 

“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

Contact Us      North America +1 877.468.6332      Europe +49 (0) 228 227 440      Click Here to Email Us

Contact Us
North America
+1 877.468.6332
Europe
+49 (0) 228 227 440
Click Here to Email Us