Our product is specifically designed to meet the needs of the clinical sector related to research and customer data management. Thanks to the architecture used, you can effortlessly distribute the responsibilities of all three entities involved in the process among designated individuals or concentrate most of the responsibilities in the hands of one person. High flexibility in the approach to responsibilities is one of the most significant advantages of our system.
The diCELLa eCRF application for clinical trials follows Food and Drug Administration guidelines (FDA 1572 and Financial Disclosure Form, FDF), so compliance with 21 CFR 312 is guaranteed. What does this mean for customers? First of all, by choosing our system, you will be assured that all procedures and output information will be up-to-date, understandable as well as acceptable in any country in the world.
Data operations carried out in our application are protected from unwanted changes thanks to the architecture of smart contracts, known as Blockchain technology. Using its achievements, we can guarantee the authenticity and uniqueness of the data entered into the system. Such a procedure is essential to eliminate the risk of substitution or falsification of information, which will play a key role in clinical trials.
The clinical trial process involves many people who are responsible for carrying out the procedure at every stage. The diCELLa eCRF clinical trials application allows monitoring of all stages of this process, so that the person commissioning the trial can be sure that it is proceeding as planned. There are three main bodies involved in a clinical trial - the Sponsor who commissions the trial and appoints the main researcher, the CRO Company that legally represents the foreign sponsors, and the Research Team whose job is to work with the preparations and patients.
They are responsible for the initiation, conduct and funding of the clinical trial. The Sponsor is an individual, legal entity or organization based in the territory of the European Union or a member state of the European Free Trade Agreement (EFTA). Typically, Sponsors are pharmaceutical companies.
This is the organization that conducts the clinical trial ordered by the Sponsor. The order is based on a contract, which includes information about the type of clinical trial activities to be undertaken by the CRO. The Sponsor can delegate its responsibilities and functions to the organization, but the responsibility for the quality and compliance of the study always remains with the Sponsor.
The diCELLa eCRF clinical trial application mirrors the structure of the Research Team, Monitor and Sponsor in a clinical trial. This means that qualified physicians, biotechnologists, as well as pharmacists are involved in the study process. With the app, members of the Research Team can easily fill out and edit the CRF records of all study participants.
The function of creating so-called data queries, that is questions about data directed to any fields or questionaries, allows users (if they are authorized to do so) to notify the doctors about possible changes in the clinical trial or any of its stages. When it happens, the doctor gains the possibility to edit, approve or reject the new query. The page is excluded from any updates until the Monitor closes this data query.
The system allows managing a large number of patients in real time. The principle of its operation is to randomly assign participants of the study to their groups (control, therapeutic and research groups) with an emphasis on obtaining equal randomization groups. Each person can be assigned to any group. An interactive module IWRS is used for this purpose. eCRF clinical trials application allows conducting simple, block, stratified and adaptive randomization.
The function was created to track and store information about changes made to the clinical observation record during the whole trial. Here you can find details of the subsequent approval phases, individual actions and even data related to entitlements. This allows to carry out control activities. Documents created with the audit trail are shared with auditors who conduct an appropriate audit.
Statistics collect basic summary information about the recruitment of patients. Here you can find the graphical representation of data collected from the entire institution and all patients. These data are available not only for Monitors and Coordinators but also for Researchers.
This is undeniably one of the most important functions of the eCRF system. Reports store information among others about adverse events, doses of tested medicine or patients participating in the trial. Reports are available for Sponsors, members of the Research Team and also delegated members of the bioethics commission.
This function shows all information about the current clinical trial, the list and details of all patients' data and also all research institutions participating in the trial. Audits can be conducted only by authorized people so you can be sure no information will fall into wrong hands.
The system supports the proper management of the tested product in terms of monitoring the product path in the ongoing study as well as supporting personnel in contact with the tested product.
The system allows you to create customized forms by using elements such as single/multiple choice fields, text fields, auto prompt fields, selection lists, dates, sliders and the Meddra search engine. With the system you can create conditions on selected fields from the entire questionnaire. There can be more than one condition and it can be based on different logical criteria (and/or).
Data security with blockchain technology guarantees authorized access and protection against data manipulation – undeniability and authenticity. Data backup is carried out in real-time. Each user of the system receives a unique ID and password, and attempts of unauthorized access are monitored and recorded. All connections are encrypted.
The system can be accessed from anywhere at any time via any web browser.
Upon the client's request, we can implement an online contracting module to optimize the contracting process and streamline processes in a research project.
An excellent alternative to paper diaries. Full integration with the eCRF system.
The application's interface has been designed in such a way that the users always know where they are. Combined with transparent navigation, this makes the entire project accessible to new customers.
With the clinical trial being taken care of by you and your designated authorities, you are assured that the selection of dates for the given tasks will be most appropriate for you.
The application allows separation of duties among different roles, so that processes at each stage of a clinical trial can occur simultaneously.
Of course, clinical trials themselves are not the only function of the application. All tasks related to the entire process (appointing people to appropriate positions, making measurements and predictions based on the data provided, collecting medical records, etc.) can be performed within our system, making it a highly multi-tasking product.
The minimalist layout, focusing only on the most important features and covering more details at lower levels, makes it very easy to work with, even when using the application for the first time.
Precision in the selection of appropriate agents is crucial in clinical trials. That is why our applications include a clear layout of tables containing information about the tested substances.
We have an individual approach to every order, so if you are interested in our offer or have any additional questions, contact us.