Data and security
Yes, data retrieval occurs once per day to verify and maintain data integrity. Data is updated when the hospital system is least busy, which is at night.
Yes, we offer a fully secure solution based on Microsoft’s Azure cloud. MCR Clinic™ systems meet the highest requirements for medical IT in Cloud and Software-as-a-Service infrastructure (Microsoft Azure, FHIR Fast Healthcare Interoperable Resource, HL7 CDA and higher for medical data storage and exchange).
Data from HIS system are downloaded through safe connection (VPN) between our system and hospital system. The connection interface is a shared database view or programmable API – in both cases we limit the scope of data to minimum and the data is anonymized.
Yes, the Clinical Site Manager™’s system automatically maps procedures or other events from the HIS by using the ICD-9 code and allows the investigator to manually verify accuracy and assign to the appropriate visit (pin or unpin).
Yes, the system uses data (name and surname) of the physician or other personnel performing a given element of treatment, so if such data is in the HIS system it will be displayed in the Clinical Site Manager™. Additionally, the system includes an FDA 21 CFR Part 11 compliant Audit Trial trail that indicates when and by whom the changes were made.
The scope of the required integration, which is the list of fields needed to integrate with the Clinical Site Manager™ system, can be found at the end of this document.
MCR Clinic™ works with and obtains anonymized data. Anonymization takes place on hospital infrastructure.
When supplying the integration/intermediary database available to MCR Clinic™ system, data of consultations and procedures performed are stripped of any personal data enabling patient identification. Only the code of this patient, which cannot be translated into his/her personal data without access to the HIS system of the facility from which the source data originate, will be saved in the database for identification of a set of medical data. Data imported into MCR Clinic™ system will not store personal data of patients participating in the study.
Yes, although it is recommended that treatment elements should have assigned ICD-9 codes. If treatment elements without assigned ICD-9 codes are imported, they can be supplemented in the system.
Functionalities
No. Many systems are used in clinical trials and will remain so (CTMS, eTMF, EMR/EHR, eCRF, LMS, etc.).
However, a common problem is dispersed information and incomplete knowledge about conducted or monitored trials. Thanks to MCR Clinic such state of affairs becomes a thing of the past, as key data are collected in one place (All-in-One), and contracting, management and monitoring is much easier – on each management and organizational level.
MCR Clinic is an extensive system containing all functionalities needed from the stage of negotiations, through creating research plan, price list, current management and remote monitoring of research, to settlement of performed/contracted services. It meets the common needs of clinical trial sites as well as sponsors and CROs. #hybridmodel
The originator of MCR CLINIC system is Mariusz Olejniczak, an innovator and experienced manager with many years of experience and knowledge, who knows (almost) everything about clinical trials. Mariusz has clinical research in his blood. He has implemented projects from recruitment, through monitoring, to study closure and accounting. He is one of the founders of the Association for Good Clinical Trial Practice in Poland. He currently heads WPD Pharmaceuticals Inc. an innovative R&D company developing drugs in the area of oncology, listed on the Toronto Stock Exchange.
MCR Clinic will work great for both commercial and non-commercial studies. All system functionalities are optimized for managing and monitoring clinical trials in #hybridmodel regardless of their nature, scale, number of participants, or centers. Scalability, simplicity and convenience of use are the features of this solution.
MCR Clinic is also part of the activities of the Medical Research Agency implementing the Clinical Trials Development Plan, within the framework of which professional Clinical Trials Support Centers (CWBK) are being created. According to ABM President Radosław Sierpiński, M.D., Ph.D., the creation of the CWBK (…) will contribute to improving the attractiveness of the clinical trials market in Poland and, most importantly, will increase accessibility to trials for patients and improve their standard and safety (source: www.abm.gov.pl).
We support the increase in the number of clinical trials on the domestic market, as well as the participants taking part in them, through a state-of-the-art, 100% Polish, best know-how-based IT solution. #hybridmodel
Many benefits, we could talk and write about it for a long time. In simple terms, #automatisation is:
Efficiency – significant reduction in manual work with data (transcription, verification, correction), both on the part of the center and CRO companies.
Cost-effectiveness – reduction of monitoring costs by replacing some face-to-face visits with remote access to data combined with full financial control on the part of the centers.
Speed – remote access to data for authorized individuals, while maintaining security procedures, regularly updated, with the ability to verify and edit data at any time.
Security – generation of statistically sound data directly into the eCRF and full anonymization of participant data as another layer of security.
The #hybridmodel is the future of clinical trials, pandemic has accelerated the shift towards remote monitoring of clinical trials but monitoring visits will still remain, at least in part. Working in this model requires IT tools of a new type.
MCR Clinic brings with it a number of benefits for all parties involved. Physical site visits are reduced to the bare minimum, yet the data is still statistically sound (or even healthier) and the risk of errors is minimized while significantly reducing the time required for communication.
The #hybridmodel increases the comfort and efficiency of researchers and CRAs. The amount of interaction is reduced but the quality of interaction increases.
MCR Clinic™ has developed 3 systems for remote monitoring of clinical trials:
- MCR Clinical Site Manager™ – a system for site managers and study coordinators for effective contracting, oversight, and billing.
- MCR eSource Remote Viewer™ (eSRV™) – a system for remote study monitoring in a hybrid model.
- Data Communication Integrator (DCI™) – a system for secure and automated data exchange between different systems used in clinical trials.
1. Generation of the participant’s source data
- full knowledge presented through a user-friendly layout about every participant, every trial, every cost associated with the procedures, and every visit that has to be conducted to obtain a healthy sample size
- automation of Clinical Trials management – automatic data download about the executed procedures
2. Auto-monitoring of Clinical Trials
- remote access to source data while providing 100% SVD at every single Clinical Trial
- automation of the monitoring process with significantly decreased number of physical visits at the Site
We strengthen the Polish clinical trials market to fully utilize its potential. The most important thing is not to waste more time on manual transcription, verifying and transferring data, or making avoidable mistakes. We believe that MCR CLINIC system is a perfect solution for conducting clinical trials in #modelhybrid, where there is more time for patients, without whom both our work and yours would be meaningless.
Sites
CSM system is the primary tool for the Investigator and their team but it can also benefit the Site, Finance or Clinical Research Directors.
We offer full knowledge about every conducted Clinical Trial, available at any given moment. We ensure full financial control over every executed procedure, no matter whether it’s required, optional or additional. All of them are marked in MCR Clinic’s system, and settlements with the Sponsor happen timely and smooth.
Thanks to the automated work, the Site increases its productivity, enabling more Clinical Trails and recruitment of more Participants.
Indefinitely. We contractually provide support free of charge for the entire term of the contract, which is for 36 months, after which it automatically transitions to indefinite term. Our commitment is then also automatically extended.
MCR Clinic™ will work great for both commercial and non-commercial research. All system functionalities are optimized for the management and monitoring of clinical trials in a hybrid model, regardless of their nature, scale, number of participants or centers. Scalability, simplicity and ease of use are the most important features of our solution.
With accordance to the mission and knowledge MCR Clinic, we exchange weeks of work performed in the traditional model for days in the automated model.
The main advantage of the CSM system is the accumulated knowledge about the conducted Clinical Trials. The knowledge is collected in one place (All-in-one) with clear division into data about a particular Participant (i.a. their study status, visits, past and future procedures, as well as costs related to them).
Another benefit is the automation of work – no more manual verification, collecting tonnes of paper, analysis of data tables or manual data input.
All this results in time saved by the whole Research Team, while the generated data is more statistically accurate than the one accumulated using the traditional methods.