Our Main Features

Service

We are dedicated to providing services to meet the ever changing needs of drug development. Together with our innovative technology and safely expertise, our team provides consulting and operational support services to set up and manage concomitant medication protocol design within your clinical trials.

Using multiaxial technology we are able to leverage information to streamline any "Front Loaded" work required for protocol drug rule development. A dedicated Pharmacist Management Team using innovative analytical technology that is configurable to the specific conditions of each trial will support, set up and manage the drug rules electronically to assist the study design team.

Global Solutions

  • Innovative multi-axial technology
  • Full support to enable compliance with GCP, 21 CFR Part 11 and other regulatory guidance
  • Graphical User Interface in easy to use Wizard format
  • Advanced Dictionary Management with fully integrated 'live' concomitant medication management analysis
  • Scalable for Global use, multi lingual and culturally specific
  • Extensive library of configurable standard reports
  • ASP.net hosted for ease of integration
  • Designed, developed and delivered according to Software Development Life Cycle (SDLC) practices (GAMP 5 Validated)

Technology

CliniSafe uses innovative multi-axial technology to provide a global solution for "real time" management of concomitant medications in clinical trials, eliminating the delay inherent in current EDC systems.

Full support to enable compliance with GCP, 21 CFR Part 11 and other regulatory guidance Supports CDISC standards Graphical User Interface in easy to use Wizard format Fully integrated ‘live’ concomitant medication management analysis Scalable for Global use, multi lingual and culturally specific Integratable Ease of integration

Investigator Attitude Survey

92% of Investigators felt a quick and effective system to monitor concomitant medications would be beneficial to their practice.

CRA Experience Survey

67% of CRAs confirmed that they have experienced patients enrolled in error into studies due to prohibited medications with occasional to frequent occurrence.

Vision and Mission

Our Vision is to prevent and eliminate inappropriate prescribing of concomitant medications to patients in clinical trials.

Our Mission is that Globally all healthcare professionals will have access to our electronic system to protect the patients they enrol into clinical trials.

Videos

Mark Dale

Steve Higham