I Am Your Patient But Do You Know Me?
Patient-centered R&D in pharma begins with understanding the patients, and Patient Profiles is the feature that enables that. The Patient Profile allows the oversight of the study-relevant parameters for all patients of a study. It improving clinical trial data quality and mostly patient safety allowing a bird’s eye view on patient history.
Patient Profiles identifies anomalies in data and presents the patient profile information in a clear, concise way, no matter where it sits in the clinical research databases.
It is fully integrated into the holistic Risk-based Quality Management (RBQM) system EarlyBird® and exclusively shows patients participating in the selected study. An anomaly detected? No problem, it is fully integrated into the issue management system, allowing to stick to the best practice Plan-Do-Study-Act workflow. Thus, all problems can be addressed as soon as they are discovered.
What to Start With? – Study Patient Details!
A single site displays detailed patient information, a comprehensive medical history, and a graphical profile displaying Visits, Adverse Events, Concomitant Medication, and Laboratory Measurements in Gantt and line charts.
The Medical History lists all captured diseases of the patient since her/his birth. It provides detailed information on the conditions, categories, and their status.
Graphical Patient Profile
This table lists all visits from the patient’s enrollment until the study end. Thereby, all scheduled visits are compared against the performed (grey), missed (white), home (pink) visits. Additionally, all planned and unplanned hospital stays of the patient during the study are listed.
A Gantt chart of all adverse events for the patient from her/his enrollment until the study end summarized the Adverse Events of the patient. Adverse Events are categorized by their severity – mild (green), moderate (yellow), severe (red).
Here, all medication given additionally to the required medication according to the study protocol is listed in a Gantt chart.
The results of all laboratory measurements for the patient are better to read as line charts. The standard value area for each parameter is shown in blue. All normal values lying in this area are shown in green. Moderately over-/undershooting values are yellow and severely differing values are red. The gray line represents the mean values of a comparative population of patients that can be selected by the user. This helps to interpret the values of the individual patient.
Summing up, Patient Profiles is the main tool for patient-centered clinical trial, as they allow to control the data anomalies and patient safety issues. Either you are a medical reviewer, a program manager, or a CRA you will find Patient Profiles useful in order to understand the medical history of each particular patient, their troubles and health parameters. As result, your study will become more patient-centered.