The collection of the data is a critical and fundamental task in any clinical investigation. The final results of the clinical investigation are the output of the statistical analysis over the data collected during the investigation, therefore, the right design and execution of the data collection process are critical to obtain a high quality and veracity data. Our platform is desgined with the main goal of getting the best possible results and to be able 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 this systems, by creating a simple,fast and realiablesolution, 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 colledted 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 establised ranges or parameters.
- Conditioned subvariables: Variables either depended or related with 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 very powerful and innovative system of automatic rules.
- Queries: Optionally you can use(configurable module), either automatic queries, manual queries or both. Our queries system will allow you to improve the communication between the monitors and investigators.
All this 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 the time and avoiding the long subsequent processes of detection and correction of errors.
ShareCRF allows you to configure in a very easy and simple way, every validation feature that you require in your project through our self-construction system, allowing you to adjust and validate every filter, validation and rules of the project both in its phase prior to the start the data collection, and in subsequent phases 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 use our platform in the most intuitive and easy possible way, with no necessity of tedious and long 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, smart phone,..etc) with a web browser (Chrome, Firefox, Safari, Internet Explorer,…etc) and internet conexion. 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 allow 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 security:
- Data encryption: Every communication in the platform is encripted 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 responsability with them. The objective is to comply strictively data protection rules of the EU. ShareCRFcomplies the neccessary regulatory requirements for clinical trials.
- Access control: Our service allows 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 previous and after value of the variable. You can find more information about the features of the audit trail of ShareCRF.
- Periodic Backups: Our service includes periodic backups of the data and their safe storing.
Adaptability to the requirements of your research
The adaptability 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 sanitary product.
- Veterinary tests.
- Longitudinal studies.
- Cross-sectional studies.
This adaptability lasts the entire duration of the project, being able to add new variables, new 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 an independent 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 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.