Navigating the complexities of clinical trials can be hard. We're here to help make your work easier. Here are some ways in which we've helped our customers succeed

Randomization and Emergency Unblinding

The project involved implementing randomization with study medication allocation and an emergency unblinding tool.

Effective Solutions for Multi-Cohort Patient Numbering

Due to the study's requirements, a complex patient numbering system is necessary. When a patient is initially created, an automated screening number is assigned based on the site and the sequence number within that site. Once the patient is enrolled, the EDC system will generate a patient number based on the subject cohort and the sequence number at the study level.

SAE Reporting functionality for Large NIS Studies

In response to the anticipation of 15,000 Serious Adverse Events (SAEs) in a large Non-Interventional Study (NIS), the Sponsor sought a solution to streamline SAE reconciliation efforts throughout the study. The goal was to efficiently inform Pharmacovigilance, subcontracted to a CRO and Sponsor, about the status of SAEs. The project involved the creation of SAE reports, based on templates provided by the Sponsor, using data already collected in the Electronic Data Capture (EDC) system. These reports were automatically generated and sent to Pharmacovigilance and Sponsor representatives. Additionally, SAE Follow-up reports were numbered, and changes to data were highlighted. Both the initial and follow-up reports needed to be emailed to the study team.

ePRO implementation

This project involved a complex ePRO setup where questionnaire availability was dependent on the visit schedule and the patient’s progress in the study. Questionnaires were to be enabled shortly before scheduled visits to allow patients to complete them prior to arriving at the site. The project also featured a multi-language approach and involved complex questionnaires requiring validation by the questionnaire owners.