Patient consent is one of the most important parts of clinical trials, yet is consistently the number three critical finding from regulatory inspections resulting in an FDA Form 483. Why is this?
Patient-level insights help medical reviewers and drug safety monitors review a patient's overall clinical trial experience in a detailed manner, while visual patient profiles represent a combination of the important CDISC domains.
Aligning the two next to each other helps the end user correlate events in one domain with findings in another domain.
Clinical research is probably the last industry on the planet where data can only be moved from one computer system to another by typing it in again. Why can't the requisite data be extracted automatically from the patient's Electronic Health Record? For years, this has been deemed impossible for a variety of technical, regulatory and patient privacy reasons.
However, with the advent of a new architecture called SMART and a new communications protocol called FHIR, the automatic extraction of data from the EHR is now eminently feasible. Watch this webinar to understand this groundbreaking technology and what it means for the future of Clinical Data Management.
Did you know that as of 15 March 2019, the FDA only supports submissions in the new WHODrug Global B3 or C3 formats? The older B2 and C formats are no longer accepted. There are a number of significant changes that will affect your coding practices and reporting systems. Are you prepared?
What does it take to bring all silos of information together for actionable insights? As biopharmaceutical organizations search for new ways to streamline clinical trials and optimize limited resources, the tools used to collect data have become less homogeneous and more disparate.
Data comes in many forms: patient data, safety data, laboratory data, regulatory information and surrounding trials management activity, all of which need to be segmented and joined to achieve the type of useful information that clinical development operations can leverage.
Abby Abraham, VP of Data Analytics and Risk Based Monitoring (RBM) at OmniComm Systems, discusses the evolution of RBI over the last seven years and the changes that have derived from this such as: Virtual Clinical Trials and the digitization of clinical research.