streamlining trial management in the healthcare centre
eSource Manager software (for hospitals carrying out clinical trials) facilitates the process of clinical trial management from the moment contract negotiations with the sponsor begin, to procedure monitoring in the course of the trial, to accounting and completion of the project.
eSource Manager features:
- Integration with the hospital IT system that allows for the utilisation of the existing data resources while maintaining the full anonymization of personal data.
- Support for the clinical trial management process from contract negotiations with the sponsor, to the execution of the trial, to accounting and records archiving:
- Creating the project: schedule, research plan (flowchart) and medical procedures price list
- Creating the team: investigators, administrative staff, lawyers
- Patients enrollment from the eHR medical database
- The entire source documentation and trial records in one place
- Ongoing monitoring of the course of the trial based on the created plan, monitoring of the executed procedures for each patient, access to anonymized medical records in eHR for the administrative staff
- Support for accounting and elimination of errors – on the basis of the price list and compilations of executed procedures, and settlements with the trial sponsor, procedures performed within the trial are not directed for the accounting to the National Health Fund
Benefits of using eSource Manager for the Site:
- standardisation of the process
– unification of procedures and documents, precise determination of roles and tasks of process stakeholders
– limiting delays and the risk of errors during the accounting of the trial thanks to the constant monitoring of the plan and the budget
- full control
– ongoing verification of procedures – those performed and not performed according to the plan and the budget, access to the current documentation at every stage of the trial
- If you have questions about eSource Manager – do not hesitate to contact us
Worthy of note
eSource Manager enables using the existing resources and data of the healthcare centre in a more effective way, in order to facilitate the management of the clinical trial process which it carries out.
As inquiries of the Supreme Audit Office in Poland revealed, in the process of clinical trials and their accounting between the healthcare centre and the sponsor, there is a possibility of the occurrence of irregularities and errors which consist in an erroneous qualification of medical procedures performed within the trial, for the settlement with the National Health Fund. eSource Manager enables to minimise the risk of such problems occurring, using data normally collected in the course of the treatment process of a patient who is at the same time a participant of a clinical trial. Thanks to the integration with the IT system of the healthcare centre, eSource Manager does not require the researcher to perform any non-standard activity related to completing the records.
Moreover, eSource Manager provides hospital organisational units responsible for the trial contracting with supervision over their course and accounting, current access to the information on the performed medical procedures and thus, constant monitoring of the entire process. All data necessary for this purpose is collected in one place, and access at particular levels is available to authorised users of the eSource Manager software.