TrialMax – an eClinical outcome assessment (eCOA) solution – will be used in a trial sponsored by an unnamed US Biotech.
The Phase III trial for prostate cancer will involve more than 75 sites in more than 10 countries, with up to 1,000 participants.
Bill Byron, VP of product strategy and innovation at CRF Health, told us, “The driver for the use of TrialMax was to obtain quality data easily. [Patient reported outcome] PRO data collected on paper is often subject to ambiguous, missing and conflicting entries. Using TrialMax to collect these data electronically eliminates these concerns.”
The sponsor partnered with CRF to use the platform to provide support in collecting clinical and endpoint data electronically. The platform was also chosen by the sponsor due to its ability to address PRO measure completion.
Participants in this study have failed all other treatment options and are seriously ill. The platform will allow the patients to conduct questionnaires and comply with the trial regulations in privacy.
“In this study, our solution means that patients can complete the patient reported outcomes measures at their own pace and in privacy, stop and starting as necessary – which is helpful if they are feeling unwell – while maintaining the integrity and completeness of the data collected,” Byron said.
CRF Health recently launched a self-service model for eConsent called TrialConsent which serves as another eCOA platform that CRF offers.