Saltware Solutions Limited

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Life Sciences Technology

eClinical software as been at the heart of Duncan’s career so building on his extensive experience in the life sciences industry, we offer a bespoke service to customers who require specific clinical data management knowledge clinical technology.

Early Phase Source Data Collection

If you need help using specific software or general advice about one of the following topics then please contact us for a consultation.

  • Volunteer Recruitment
  • Direct Data Capture (DDC)
  • eSource Data Collection
  • Laboratory HL7 Messages
  • Laboratory Sample Tracking
  • Pharmacy Inventory Management
  • Data Exports and Reports
eClinical Software

Clinical Trial Management System (CTMS)

Site and sponsor CTMS software a required to have many features because they are geared towards users that have opposing perspectives. A sponsor focused system is used by pharmaceutical companies, biotech firms, or other organizations sponsoring the trial clinical trial sites, whereas site users such as clinical trial units, hospitals or research centers need software suited to executing the trial at the site.

A site might expect the following features:

  • Study Feasibility: Assessing the site’s ability to conduct the trial.
  • Workflow Management: Streamlining the daily operations of trial coordinators and investigators.
  • Data Management: Centralizing trial-related information and improving data management.
  • Patient Tracking: Managing patient recruitment, enrollment, and retention.

The sponsor will expect the following functionality:

  • Study Planning and Tracking: Overseeing the entire lifecycle of the trial, from planning to execution and reporting.
  • Regulatory Compliance: Ensuring adherence to regulatory requirements and guidelines.
  • Financial Management: Budgeting, cost tracking, and financial reporting.
  • Site Performance Monitoring: Tracking the performance of multiple trial sites and ensuring consistency and compliance.

This is by no means an exhaustive list as there are never-ending requirements to manage a trial well. Even with a well-designed CTMS there will be situations that require ad hoc management outside of a dedicated system and very often this area is around project management activities such as assigning tasks, co-ordinating resources, and ensuring milestones are met. Very often spreadsheets and similar desktop tools are used which can expose the organization to risk that could cause a serious impact to the trial.