Electronic Patient Reported Outcome (ePRO)
Clinical Trials & Digital Health
Our client, a top global pharmaceutical company wanted to conduct a hybrid virtual clinical trial for a whitepaper study on patient engagement and retention, which was to be submitted to the US FDA. Their primary goal was to provide patients complete flexibility to participate in the clinical trial without physical access to a centralized site. Additionally, they also wanted to Collect Trial Data (EDC) on ailment prominent in the children cohort by engaging them in a simulation game. A masked questionnaire in the game acted as a data capture point.
The game and app were built considering the engagement spectrum of children. The game had a ’loot’ system which when clicked grants goodies for answering questions in the eDiary. The entire designing phase went through a mandatory review from C-PATH for regulatory approval.
To ensure that data collaboration and collection were pristine, we created a SDTM compliant Data Protocol, which defined how data is to be collected, managed, transferred and monitored during the trial.
The CMS web platform allowed site managers to initiate a patient in game once enrolled in the trial. These IDs were generated via randomization algorithm and were abstracted from the CRO.
The CMS kept track of various trial metrics necessary for trial managers to handle the patient cohort.
Apart from a significant overall trial cost reduction, Electronic Data Capture (EDC) allowed responses to be received directly from the patients via an interactive game without the intervention of Clinical Research associates, thereby minimizing loss of data in translation from the patients. Data was securely captured and transferred to CRO with the help of guidelines and rules set up in the Data protocol, with relevant DQ, IQ, OQ, PQ documentations in place for the product. It also eliminated the need for patients to physically visit the sites.
Our Digital Solution simplified the lives of Healthcare Stakeholders, Trial managers & Patients.