Clinical Trial Data Management System

Clinical Trial Management System forms an important part of Clinical trial process. It assists clinical research professionals in collecting, managing and collating comparable reports of study data. They should also assist sites in collecting Trial specific data, track study performance, scheduling and well-informed decision making.

Flexibility and scalability are need of the industry for any software in the market for clinical trial operations, thus enabling organizations to manage and collaborate with its own units or with the partners. With the improved and harder regulatory standards, meeting 21 CFR Part 11 compliance is a necessity.

Business Challenges

  • Planning, collecting, managing and controlling of study data.
  • Scheduling, tracking, Decision making of all tasks related to Clinical Trials management.
  • Compliance to Industry regulations.
  • Flexibility and scalability to handle large amount of data.
  • Rising investments and costs.
  • Processing of redundant data.
  • Shorter go-to-market timelines.

Our Services

Nous understands the domain and related IT solutions for the heavily regulated industry of Lifesciences. The Clinical Trial Managements are not similar to many other solutions and Nous has built experience and expertize by working with prominent customers and is well equipped to provide solutions meeting all the regulatory requirements.

  • Clinical Data Management System
    Design and develop Patient Investigation and Recruitment, Clinical Site Monitoring, Protocol Management, Adverse Event & Report Management modules in Clinical Trials Management system.
  • Clinical Protocol Management System
    Integration with core clinical systems – electronic data capture (EDC), clinical trial management (CTMS), and clinical safety using the latest technology (SOA/web services) and industry standards (ODM).
  • Clinical Integration systems Reusable check-list for integration with Medical records system for faster integration.

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