SMARTrials®: Goal- and Process-Driven Approach

SMARTrials® goes beyond being just a software.

It is a Clinical Trials Management Platform (CTMP) that integrates all key processes on a single platform. 

It is a comprehensive management framework designed to effectively achieve precise business, organizational, and research goals.

SMARTrials® was built from the ground up to support the performance management cycle: planning, monitoring, feedback and improvement, evaluation, and reward.

What Sets Us Apart:

Deep understanding of clinical trial processes gained through years of experience in the industry.

Scalability. SMARTrials® allows you to manage not only a single trial but also an entire research organization and network of study sites.

Multi-level performance management tools for teams, projects, and organizations, using real-time data and forecasting to enable error correction and performance improvement.

Why SMARTrials®?

When it comes to clinical trials, effective organizations are known for:

Conscious management of organizational and research processes.

Planning activities based on precise business and quality goals.

Proactive management of organizational and team performance..

Providing patients, CROs, Sponsors, and other stakeholders with the highest value.

By selecting SMARTrials®, you choose a process- and goal-oriented management philosophy.

SMARTrials® for Clinical Study Sites

Rise Above, Reach Beyond

Top Six Benefits of Implementing SMARTrials®

Standardization and automation of processes. This minimizes the time to complete tasks, increases processes speed, and reduces errors.

Remote management and delegation of tasks to teams and employees. This allows for greater flexibility and efficiency in work execution.

Real-time monitoring of results and task completion. This provides excellent situational awareness and prevents surprises.

Ensuring compliance and quality of data and documents. This reduces the risk of legal and financial liabilities.

Payment management and control over resources. This ensures organizational efficiency.

Easier transfer of the business to a new management team or owner. This simplifies the transition process and reduces the risk of disruption.

What Tools Will You Get?

A process-oriented CTMP (Clinical Trials Management Platform) in SaaS (Software as a Service) version for comprehensive management of all key processes in the study site, allowing for:

  • planning and managing the efficiency of all aspects of the site’s work;
  • budgeting and accounting for the finances of the site, research teams, and research projects;
  • implementing the research process from study startup to study closeout;
  • management of site resources, including personnel, offices, equipment and technical passports, investigational medicinal product (IMP);
  • support for the patient recruitment process and management of their participation in the study;
  • management of site documentation (eISF) and source data (eSource Data);
  • real-time monitoring of task completion and budget status thanks to dedicated dashboards, and reports.

Access to platform functions, information, and reports tailored to the user’s role in the study site and the tasks they perform.

Integration of the platform with SMS, email, and call center services.

Automation of study protocol creation on the platform to proactively manage their progress through alerts and reminders.

Workflow management in your study site and your study teams.

Ability to add new study sites when building a network.

What Kind of Support Will You Receive?

  • System implementation and adaptation to the specific needs of the site and the team.

  • Position-specific training for dedicated personnel.

  • Post-implementation support

  • Support in adapting organizational processes to maximize the efficiency of the site and your teams

  • Comprehensive support for budgeting and management of sponsor and team settlements, as well as debt collection by a dedicated settlement management team (additional service as per agreement).

  • Data management and research configuration (additional service as per agreement)

  • Support for the patient recruitment process (additional service as per agreement)

  • Expert and technical support in case of a desire to develop a network of study sites (additional service as per agreement).

SMARTrials® for Sponsors & CRO

Harness Your Network Full Potential

Top Six Benefits of Implementing SMARTrials®?

Centralized management of processes and tasks across the network from a single management dashboard.

Seamless flow of information, tasks, documents, and decisions throughout the network.

Standardization of tasks, documents, and data, consistency of operations across the network, comparability, and ease of evaluation.

Automation of processes for research, payments, recruitment, infrastructure, and personnel.

Full situational awareness and control across the network through real-time monitoring.

Integration of information and documents - speed, increased organizational efficiency, and lower risk of errors.

What Tools Will You Get?

Process-oriented CTMP (Clinical Trials Management Platform) in SaaS (Software as a Service) version which:

  • enables the creation of an effective shared service center for a network of study sites;
  • can be easily scaled as the size of the network of sites grows
  • allows for comprehensive management of all key processes;
  • enables planning and managing the performance of all aspects of the work of the network of sites and individual sites;
  • provides integrated eCRF and IWRS modules, sponsor (eTMF) and site (eISF) documentation as well as source data (eSource Data) management tools;
  • facilitates budgeting and accounting for network and site finances, study teams, and ongoing research projects;
  • enables the centralization of the startup phase;
  • provides the possibility of centralized or distributed management of different stages of the clinical trial until its closure and settlement;
  • facilitates the management of resources in the site network, including personnel, offices, equipment and technical passports, investigational medicinal products (IMP);
  • provides synergistic coordination of the patient recruitment process for trials within the site network and supports management of patients’ trial participation;
  • enables real-time monitoring of task completion and budget status across the network thanks to dedicated dashboards, and reports.

Role-based access to system features, information, and reports.

Integration with SMS, email, and call center services.

Automation of study protocol creation within the system to proactively manage their progress through alerts and reminders.

Workflow management in study sites and teams.

What Kind of Support Will You Receive?

  • Implementation and adaptation to the network's business model, organizational structure, and team composition

  • Position-specific training for dedicated personnel.

  • Post-implementation support

  • Organizational processes optimization to maximize sites and teams performance.

  • Comprehensive support for budgeting processes and management of sponsor and team settlements, including debt collection by a dedicated settlements management team (additional service as per agreement).

  • Data management and studies configuration (additional service as per agreement).

  • Patient recruitment support (additional service as per agreement).

  • Expert and technical support in case of interest in expanding the site network (additional service as per agreement).

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