Bringing simpler solutions to complex trial data
Committed Professional Teams
Complex trials offer unique challenges and having an experienced team supporting you can make all the difference. Oncology studies are notably more complex as the protocol requirements include managing multiple cohorts, managing cycles of treatment dynamically, more inclusion and exclusion criteria and the studies have more external data including Local Labs, Central Lab, PK/PD, Biomarkers, input from biopsies, etc. ultimately resulting in a greater amount of data to be cleaned, aggregated and analyzed.
Our team bring a depth of experience in dealing with these requirements and can help advise on the best solutions. Our team understands the nuances of these studies ranging from how to program a study visit cycle that may be open ended to approaches to handle the higher volume of SAEs often associated with a particular subject population.
“I rely on my experience working on complex trials to support ongoing downstream review and analysis during the conduct of our studies. I find in a lot of cases the dictionary versions that are utilized may not include therapies being administered to a patient. My experience and knowledge gained working at complex trials research focused organizations has enabled me to perform and oversee the coding team effectively. This expertise has driven both quality and higher degree of efficiency.”
“We are integrating a Medical Data Review (MDR) review team as part of our data management solution. The MDR role complements the existing data review team, adding a review from the perspective of a medical professional. The MDR looks at the data holistically and for data congruency…in complex trial studies, they look at qualifying disease histories, eligibility criteria, reported tumor measurements and response assessments to ensure consistency with the protocol response criteria, lab values against adverse events, and ensure that adverse events aren’t being under or over reported. elluminate® is used to drive this review through the aggregation and visualization of data from multiple sources.”
“It’s critical for clinical teams to track details about tumors from one visit to the next (size, progression, etc) and the complexity of protocols can make this effort cumbersome and error prone. I have had the opportunity to deploy powerful visualizations within elluminate® that help identify any signals helping our data management and client project teams take better decisions on an ongoing basis during trial conduct.”