Services / e-Clinical (electronic CRF)

e-Clinical (electronic CRF)

Investigación

New technologies play an important role in clinical investigation and at Evidenze we rely on its use.

Our goal is to make all tasks easier for investigators and sponsors, simplifying the data entry and analysis process.

This idea led us to become leaders on developing electronic Case Report Forms, e-Clinical.

Currently our company has the confidence of having successfully passed over 50 IT Audits and inspections during the last 3 years.

e-Clinical is our way of looking the web in regard to investigation projects. A product designed to make differences. A modular application adaptable and customizable to our client needs.

Some of the Main Features Are:

  • Developed under the highest quality standards, it has been designed and validated following the GAMP 5 guidelines and is 21 CFR Part 11 compliant
  • User-friendly, powerful and responsive interface.
  • Digital signature: all the data saved is signed automatically. Patients can be also certified by a principal investigator signature.
  • Audit Trail, all data is traceable, you always know when it has been saved, why and by whom. You can choose a timeframe and the system will highlight all the changes done in that period.
  • Automatic queries and consistency checks to guarantee a better quality on the collected data.
  • Electronic monitoring query system, the CRA has total control of monitored data. Modifications can be denied at form or field level, and in case of need queries can be generated in specific variables. Don’t waste your time reviewing what has been reviewed. The monitored data can only be modified with queries.
  • Randomization, our system supports all types of randomization models. The investigational product can also be managed and stocked directly in the system.
  • Real time data access, reports, summaries, graphs and much more.
  • Export data module, data can be exported in many different formats (Pdf, Excel, CSV, Access, SPSS, etc.).
  • Automatic alerts and notification system (enrolment emails, AE and SAE notifications, treatment expiration alerts, etc,).
  • eConsent, patients can sign up the informed consent directly in the system.
  • Electronic Patient-Reported Outcomes (ePRO), the patient data is collected via App and is centralized and accessible from the same clinical platform