Clinical Trial Management System

Quality Controlled Trial Management System (QCTMS) is an online Clinical Trial Management System used by many small to midsize pharmaceutical, biotech and medical device companies and CROs to plan, administer and control the essential aspects of clinical trials.

Differently to other CTMS solutions QCTMS has been developed by a clinical study team of experienced project managers, clinical monitors and GCP auditors. The systematic functionality is highly adaptable to sponsor-specific workflows and terminologies. With QCTMS, clients do not need to modify their working practices and compromise with inflexible, rigid functionality. The system is able to manage trials of any complexity and support organizations of any size and global reach. Containing all operational trial data, QCTMS allows consistent and accurate information to be shared across the companies, partner and service providers, thereby facilitating timely and informed decision making.

QCTMS is available as an on-demand, software-as-a-service application enabling customers to enjoy rapid and flexible deployment of our Clinical Trial Management System solution without high upfront costs or need for extensive training. Customers can also choose to implement QCTMS as an on-premise solution and implement QCTMS it within their own operating environment.

QCTMS provides an application framework in which we are able to converge our integrated suite of clinical trial software applications. Designed to maximize the benefit of natural trial process workflow, QCTMS enables users to plan, design, collaborate and conduct their clinical trial programs from a single point.

The automated integration with QCTMS PM (QCTMS Project Management), QCTMS RM (QCTMS Risk Management), QCTMS EDC (QCTMS Electronic Data Capture), QCTMS IRT (QCTMS Interactive Response System) and QCTMS TMF (QCTMS Trial Master File) allows users to seamlessly share trial data without having to duplicate activities, helping your entire organization benefit from the true power of QCTMS.

QCTMS Modules

  • QCTMS PM – Supports project management teams to keep oversight about large trials. It controls budgets, investigator fees, milestones, timelines, enrollment summaries and responsibilities. It gives automatic instructions and guidance to the clinical monitoring teams who can report offline onsite information during site visits or during their journeys to the system. All tools work with standard software, no additional software needs to be installed on the computers of QCTMS users.
  • QCTMS RM – Makes your projects transparent for project teams. It analyses, tracks and alerts key risk factors of all projects and trials through the countries and sites involved, to details of the patients and their progress through the trial. QCTMS also documents your Corrective and Preventive Actions (CAPA) to avoid critical audit and/or inspection findings.
  • QCTMS TMF – The electronic Trial Master File of QCTMS can be fully adjusted according to individual SOPs of the sponsor or CRO. The centralized approach is an excellent solution for multinational trials. Documents of each attending country can be filed and maintained centrally from the first day until the end of the study. Security, access control and movement control is continuously ensured.
  • QCTMS EDCThe e-CRF module of QCTMS provides everything modern eCRFs can provide. The advantages of receiving real time data, faster database logs and increased data quality is commonly known. The reason for not using EDC is usually the higher price compared to paper based CRFs. Using QCTMS EDC does not increase project costs even for smaller projects. In connection with the RM and PM modules of QCTMS projects can be run for 30% lower costs while achieving a higher level of quality.
  • QCTMS IRT – The interactive response technology of QCTMS allows centralized web based randomization and drug assignment in an extremely user friendly way. We know that site personnel are normally not very knowledgeable in sophisticated IT environments; this fact alone allows  us to develop a simple, easy-to-use electronic tool which ensuring compliance by every user.

Key Features

  • QCTMS is a solution that provides the entire range of  trial planning, start-up, monitoring, financial administration, supplies tracking and investigator management functionalities
  • Available as a software-as-a-service application enabling rapid and flexible deployment without high costs or ongoing infrastructure investments
  • Highly configurable and adaptable to sponsor-specific workflow and terminology
  • QCTMS allows for seamless integration with other data sources such as medical devices