The collection of the data is a critical and fundamental task in any clinical investigation. The final results of the clinical research are the output of the statistical analysis over the data collected during the study, therefore, the right design and execution of the data collection process are critical to obtaining a high quality and veracity data. Our platform is designed with the primary goal of getting the best results, and to achieve it, we use the most current technologies.
The use of electronic tools to collect data in clinical studies significantly reduces the cost, times and mistakes in the clinical research process. Our electronic case report form is designed to increase even more the productivity of these systems, by creating a simple, fast and reliable solution, getting rid of the biggest blockers and making this task as simple as possible for the investigators, promoters, CROs or any person involved in the process of collecting data for clinical investigation.
Quality of the collected data
Ensure the quality of the collected data during the study. Our electronic case report form has multiple properties to achieve it:
- Edit checks on variables: Real-time automatic validation of the data entered in the variables, allowing only to enter correct values and within the established ranges or parameters.
- Conditioned subvariables: Variables either depended or related to other variables can control when subvariables can be filled when complying with the established values.
- Custom advance validation rules:It allows to relate values of different variables to detect inconsistencies in the record’s data with a robust and innovative system of automatic rules.
- Queries: Optionally you can use(configurable module), either automated queries, manual queries or both. Our queries system will allow you to improve the communication between the monitors and investigators.
All these mechanisms of control and improvement in the quality of the data are run in real-time, allowing the detection of errors at the very same time that the data is entered, helping researchers and monitors to reduce mistakes in a significative way, pushing the error forward in time and avoiding the long subsequent processes of detection and correction of errors.
ShareCRF allows you to configure effortlessly every validation feature that you require in your project through our self-construction system. This will enable you to adjust and validate every filter, validation and rules of the project both in its phase before the start the data collection, and in subsequent stages in which the data collection has already begun, without the need to interrupt users in their data collection process thanks to our independent test environment.
Easy to use
Usability for ShareCRF is one of the main features. Our aim is for users to utilise our platform in the most intuitive and easy possible way, with no necessity of tedious and lengthy training programs.
Our electronic case report form does not require any installation of software in your devices. The only requirement to be able to use it is to have a device(computer, tablets, smartphone,..etc) with a web browser (Chrome, Firefox, Safari, Internet Explorer,…etc) and internet connexion. All this facilitates the implementation and use of ShareCRF for all users.
The promoters of the study will not have to install any software in their servers either, because ShareCRF is offered as a service in the cloud, facilitating its implementation and maintenance. In addition, it allows in a simple and easy way the creation and case report form visual edition. All this functionality and much more enable our clients being more productive and agile.
Security is essential in electronic data collection for clinical trials. Our electronic case report form complies with the highest quality standards of safety:
- Data encryption: Every communication in the platform is encrypted by RSA 2048-bit certificate(SHA2-256) and advanced settings to achieve the highest score (A+) in the SSL Labs security test.
- Most secure cloud: Our server infrastructure uses AWS (Amazon Web Services) services, and we operate in a shared environment of responsibility with them. The objective is to comply with strict data protection rules of the EU. ShareCRF complies the neccessary regulatory requirements for clinical trials.
- Access control: Our service allows you to configure and manage the user access, allowing you to define the level of permissions and allowed actions per each user.
- Audit Trail: Our electronic CRF allows to store the changes made in the data of any record of the study saving who did it, when and the variable’s value previous and after the change. You can find more information about the features of the audit trail of ShareCRF.
- Periodic Backups: Our service includes regular backups of the data and their safe storing.
Adaptability to the requirements of your research
The versatility of our electronic case report form allows our clients to define the characteristics and modules that will be part of their project, in this way ShareCRF adjusts to the needs of their project, allowing us to adapt ourselves to all types of clinical investigations:
- Clinical Trials.
- Observational studies.
- Patient registries.
- Nutrition studies.
- Post-authorization tests.
- Testing of the sanitary product.
- Veterinary tests.
- Longitudinal studies.
- Cross-sectional studies.
This versatility is for the entire duration of the project. Add new variables, values, texts, explanations or even modify any element of the eCRF yourself at any time, through our self-construction system and completely safe through our independent test environment, which will allow you examine and validate any changes in a separate environment, before proceeding to publish them finally into production environment.
Export and Analysis of data
Our service ShareCRF allows you to export the data of the study anytime you wish, and choose the format that suits you best to proceed the statistical study of the data with your preferred software: Excel, SPSS, SAS, R, Stata…etc.
And much more
Our electronic CRF has many more features. If you are interested in our product, request a free demostration and you will be able to check our ShareCRF service in a quick teleconference.