CRF Health, a Plymouth Meeting, Pa.-based global provider of electronic Clinical Outcome Assessment (eCOA) solutions for the life sciences industry, has launched TrialMax ConMed, an eDiary-based solution designed to enhance the real-time collection of concomitant medication data from patients in clinical trials.
Sponsors commonly wait for a patient's site visit in order to enter concomitant medication data into electronic data capture (EDC) systems. This can be problematic as it relies on the patient's ability to recall all the different medications and doses they have taken between visits. TrialMax ConMed makes it simple for patients to report medications that they are taking alongside a study drug in real-time. The solution not only enhances patient safety and the accuracy of the resulting regulatory submission, but will ensure sites and sponsors achieve information on a patient's complete medication list for the duration of a clinical trial.
Although difficult to capture, accurate concomitant medication data increasingly is required by regulators for a more complete assessment of the study drug. For example, if an oncology study requires the identification of any pain medication that a patient is taking, patients need to be able to provide their clinician with information on any prescribed and over-the-counter pharmaceuticals that they use. TrialMax ConMed allows patients to select from a predefined list of commonly taken medications or enter a new drug into their TrialMax Touch eDiary electronically.
With access to TrialManager, CRF Health’s online patient management portal, investigators are alerted to new medication entries to allow them to assess the completeness and accuracy of the data and correct as appropriate. Easy-to-use for both sites and patients, TrialMax ConMed ensures users remain compliant and continue to input new medication details throughout a study.
"In the difficult work of understanding the impact of a new treatment, tracking a patient's intake of non-study medication is becoming an increasingly important regulatory requirement and we recognize that it is a challenge when this type of information is only being provided during intermittent site visits,” said Paul O'Donohoe, director, Health Outcomes, CRF Health. "TrialMax ConMed makes it easy for patients to contribute real-time medication information in a way that is both accurate and does not add an additional layer of burden, while minimizing the potential for human error when trying to recall medications and doses at site appointments. At the same time we can ensure that study teams are prompted to review any changes, bringing new awareness of the use of concomitant medication in clinical trials."