eCRF – clinical
trial software
Safety and credibility of clinical trials.
Compliant with FDA standards
eCRF – clinical
Our eCRF is:
Our eCRF solution was created on the basis of many years of experience of researchers and medical teams with whom we carried out research projects. The system is, above all, easy to use, user-friendly and extremely flexible.
The prepared solution meets all the required quality standards, and thanks to the full control over the code, we can further develop and adapt it to the changing requirements of regulators and the clinical trials market.
The eCRF TTSI
system will allow you to:
1
Support multiple clinical trials in one place
Our eCRF supports the process of designing and managing multiple clinical trials. In each study, a view of the full list of patients is available, showing the stages they are currently in with the possibility of managing a given patient in the study (randomization, dispensing / returning of test products, management of patient samples).
2
Designing a clinical trial
The system enables the creation of a clinical trial in accordance with its protocol and schedule, reflecting the full structure of the course of the clinical trial. It enables the ongoing implementation of modifications resulting from the approved next version of the clinical trial protocol.
3
Randomization
The system enables configuration of randomization in a given clinical trial, taking into account e.g. appropriate randomization method and study arms. The randomization process is carried out in the application automatically by assigning a randomization code based on the criteria specified in the Study Protocol.
4
Managing the test product
eCRF allows you to keep a register of tested products and monitor their condition by notifying the supplier of the demand for delivery of a batch of products, marking defective / disposed of packaging, and alerting the user about the upcoming expiry date of the package. The system enables the dispensing of products to the patient, and in the case of blinded studies, it automatically takes into account the arm to which the patient was assigned during randomization. In addition, it allows you to track the full history of the circulation of a given product.
5
Sample register
The eCRF system allows you to keep a register and monitor all stages of processing samples with biological material collected in a given study, which are often sent to an external supplier / laboratory for diagnostics.
Advantages of our eCRF system:
- Automatic generation of a unique code for each newly introduced patient, according to the rules defined in the study.
- Automatic sending of notifications to a defined group of recipients; for example, about a reported adverse event.
- Tracking changes for each event reported in the system (Audit Trail) – viewing the history of all data edits entered into the system.
- On-the-fly data validation and the ability to query entries (Data Query). Marking of checked data and, in the case of detection of irregularities, applying a query to an attribute.
- Automatic randomization with assigning the patient a randomization code.
- Distribution of the tested product – full synchronization with the tested product management module.
- Create forms that are then used in the study wizard to map the schedule.
Data validation reduces the possibility of entering erroneous information, and also enables the detection of deviations during data entry, by:
- A wide range of different types of attributes (single / multiple-choice dictionaries, numeric, logical, text fields, section, static text, date and time fields, dynamic / static tables, file upload field, images).
- Edit check – requires normalization on the attributes, i.e. conditions that will be verified on an ongoing basis, after entering data into the attribute. The system displays an appropriate message to the user if the value entered in a given attribute does not meet the standard, e.g. as in the case of laboratory tests.
- Requires logical conditions on attributes under which data filling is available.
- Overlaying validators on attributes (maximum number of characters / maximum value, minimum number of characters / minimum value, required field).
- Forms versioning
Turn data into knowledge!
Range of services
1. Stage before the test
2. During the study
3. After the study is completed
1. Stage before the test
- Substantive consultations and support in the preparation of the Research Plan.
- Support in selecting the sample size. Our approach is based on the Monte-Carlo simulation methodology. Thanks to this method, we are able to calculate the required sample, taking into account the researcher’s uncertainty as to the expected effects (e.g. their exact strength), inter-correlation between the variables, the expected dropout or adherence. The sample size calculated in this way is more conservative, i.e. safe from the Sponsor’s point of view.
- Test simulations and endpoint optimization. We are able to program a computer simulation of the test course. Thanks to this, we can compare various endpoint formulas and methods of their statistical resolution. As a result, we can indicate the optimal formula – characterized by the highest possible power and the lowest possible sample size.
2. During the study
- Automatic Anomaly Detection. This unique feature of our eCRF system means that it is able to show the Monitor data points that “stand out” from the rest. This makes Risk Based Monitoring easier, and potential problems can be spotted faster.
- Interactive dashboards. Our system is easily expanded with interactive dashboards that can, for example, describe the state of the trial, show the state of the trial in the area of security, or even show the prognosis for reaching endpoints.
- Interim statistical reports. Thanks to the full integration of the programming and statistical teams, we can start statistical work long before the survey database is closed. Thanks to this, reports are available faster and can be generated more often at no additional cost (e.g. every quarter instead of one-off at a given level of sample implementation).
3. After the study is completed
- Reproducible statistical reports. Our reports are based on Free and Open Source Software (FLOSS). We attach the source code and the definition of the runtime environment to each report. As a result, our reports are fully reproducible. Thanks to this, even after many years, it is possible to reproduce the obtained results or introduce modifications to the analyzes.
- Generating hypotheses for further research using Machine Learning (ML) and artificial intelligence (AI / SI) algorithms. Our experience in medical and non-medical analyzes allows us to use “black-box” algorithms, such as artificial neural networks, to discover relationships hidden in the given data. We have proprietary algorithms that separate findings worth being interested in from “false alarms”.
- Construction of classifiers for clinical use. We are able to use the collected data to create decision algorithms for future data (e.g. classifier predicting treatment response, drug resistance, duration of treatment, etc.).
- Support in writing scientific articles. We often co-publish scientific articles together with our clients. We understand the process of creating articles, we can talk to journal reviewers.
We work with:
Ask us a question
KAMIL SIJKO
DATA SCIENCE DEPARTMENT DIRECTOR
PIOTR PECKO
SALES DIRECTOR
www.ttsi.com.pl
sales@ttsi.com.pl
phone: +48 661 900 265
NIP: 527-294-32-09 | REGON: 387666213 | KRS: 0000872108
TRANSITION TECHNOLOGIES SCIENCE Sp. z o.o.