Case report form

Electronic Case Report Form (eCRFs) have obtained an important role in clinical research industry. These platforms allow store the information collected in a study in a quicker and easier way than the traditional paper CRF.

We have our own eCRF, CEDExp, in the development of which is continuously working the IT department of Experior. Apart from the regulatory and legal aspects that every eCRF must include, it focuses on developing a user-friendly interface that allows each user (Data Entry, CRA, PI, Data Manager) to work easily, focusing on the most important tasks of their profile.

In Experior we are experts in eCRF design, from observational studies to small and large-scale clinical trials, each one of them customized according to each protocol requirements.

eCRF management

Monitor / CRA

Environment designed to perform monitoring based on risk.

Its design allows to distinguish the monitoring type: Source Data Verification (SDV) performed only by CRAs and remote monitoring that can be performed by both CRAs and Data Managers.

Queries management

The queries management system allows the Data Entry designee to locate quickly an opened query through a graphic interface, as well as the CRA / Data Manager to detect those that has been answered by the Data Entry designee. This allows a smooth management of queries reducing deadlines and costs.

Data Entry / Study Coordinator

Focused on providing quickly the Data Entry designee with the visual information required to know which was the last visit entered, which one is complete and which one has queries in open state that requires his/her attention

Security/validation

It allows the modification by authorized users of the eCRF when data entry has already been initiated to adapt to amendments (new questions, changes in the type of data collected, etc.).
Compatibility with all the latest versions of different browsers (Internet Explorer, Microsoft Edge, Mozilla Firefox, Google Chrome, Safari).
Our eCRF has an Audit Trial system that allows to register every change made in the database, as well as the user registration and the moment when the change was made.
The eCRF access is always performed in a secure way (HTTPS).

Validation process: Both the initial installation and the subsequent modifications are validated following the standard procedures defined by Experior. We provide validation certificates to our clients, so they can simplify their own validation processes
CEDExp meets the legal, security and quality requirements: FDA 21 CFR Part 11 and EMA Annex 11, offering data security, traceability and completeness.
Every eCRF designed in Experior is stored in a separate server with the ISO/IEC 27001 Information Security Management certification.