QCTMS


Good bye, spreadsheets

How much time do you spend copying trial-related data from one spreadsheet to another just to keep track of your trial? Many of our customers have told us that they spend a significant amount of time every week updating and merging spreadsheets. Now imagine a tool that lets you retrieve all relevant information with just a few clicks – that’s QCTMS.

Sources of QCTMS data and the risk management process according to ICH Q9

The data sources of QCTMS RM and the risk management process according to ICH Q9

Intuitive and flexible

QCTMS – Quality-controlled trial management system – is a highly flexible application framework that assists in conducting all relevant clinical trials activities, e.g. planning, start-up, monitoring, and administration. QCTMS was designed by a team of experienced project managers, clinical monitors and GCP auditors. Unlike other CTMS tools, it is not rigid or cluttered. QCTMS uses an intuitive user interface and is adapted to our customers’ specific needs.

Software as a Service

QCTMS runs as a web application on most modern web browsers as well as on older web browsers. There is no need to reduce security settings or maintain outdated browsers. QCTMS is provided as a service and does not require investments in hardware or time-consuming client installations.

Smart forms

QCTMS uses smart forms for data entry. These forms can be edited within Adobe Reader©. They can even be used offline, e.g. on business trips. QCTMS forms allow extended checks, dynamic tables, image uploads, user assistance etc.

Ensuring sponsor oversight

The FDA requires sponsors to ensure trial oversight, which can be quite demanding. QCTMS is your key to efficient oversight providing you with all necessary trial information at a glance.

Modules

QCTMS modules are automatically integrated and allow users to share trial data between these modules. According to your company’s needs, you can assemble your individual QCTMS package from the following modules:

  • QCTMS TMF: Maintain an electronic and audit-trail equipped Trial Master File, which can be accessed from computers all over the world.
  • QCTMS PM: Track trial-related processes and explore data by using individually designed reports. Identify and understand deviations on different scopes by drilling-down to source documents.
  • QCTMS RM: Report, evaluate and mitigate risks according to ICH Q9. QCTMS RM automatically gathers risk-relevant data and creates intuitive dashboards. In case of alerts it allows you to document corrective and preventive actions (CAPA).
  • QCTMS EDC: Use electronic Case Report Forms (eCRF) to receive data faster and with higher data quality. Even for smaller trials QCTMS EDC can often be setup for a lower price than paper CRFs.
  • QCTMS IRT: Offer your sites an easy-to-use interface for screening and randomization that lets you benefit from faster availability of patient data.

Modules of QCTMS