Bioclinica eHealth Solutions, which provides an agile ecosystem and domain expertise for sponsors and CROs to speed clinical development, announced the launch of Clean Patient Optics, a first-of-its kind, fully-validated clinical trial software solution that surfaces insights to patient data for accelerated database lock and clinical trial timelines. The innovative product provides uninterrupted visibility into patient data status at the study, site and patient level, empowering study teams to optimally focus the data cleaning process and remove obstacles that can create costly delays.
"Achieving database lock on time can be difficult, especially in larger trials with a vast amount of data to review and reconcile," said Bioclinica's eHealth Solutions Chief Technical Officer Andrew Masters. Clean Patient Optics is a technology-enabled solution for faster, easier and more efficient data cleaning and reconciliation. "Users apply insights to focus data cleaning, allowing the study team to meet or beat the database lock goal by days or even weeks."
Moreover, Clean Patient Optics serves as an early warning system, signaling if a vendor is behind on making updates, or if a site is slow in reporting SAE information to the pharmacovigilance team. With powerful data visualization tools at their fingertips, study teams can uncover patterns and observations about the status of patient data external to the EDC system, such as ECG, Central Safety Lab and other important data requiring reconciliation, helping avoid surprises at the end of a study.
The entire study team benefits from Clean Patient Optics. Executive level personnel get answers about overall study health and team progress toward the database lock goal. Study managers, data managers and monitors see at a glance if a patient has reached the end of the study and any remaining data activities. They can quickly spot missing information, items to be reconciled, terms to be medically coded and pages to be source document verified.
The benefits of implementing Clean Patient Optics for visibility into patient data cleaning include:
Clean Patient Optics is readily implemented as a companion product to Bioclinica's best-in-class Express Electronic Data Capture (EDC) system and Data Management services─the enterprise solution of choice for pharmaceutical companies and CROs.
"Our seamless solution provides sponsors and CROs unmatched capability to understand study health for accelerated clinical trial timelines," Masters commented. Clean Patient Optics is another example of how Bioclinica continues to invest and innovate. "We're pleased to deliver solutions in more areas of clinical development than any other technology provider, enabling organizations to see more clearly in their clinical research─and where it makes a real difference."
Deployment is fast and easy on all new studies where Bioclinica's Express EDC and Data Management solution are in use, requiring little time and effort to learn and use effectively. "All studies, no matter the size or therapeutic area, can benefit from Clean Patient Optics," Masters added.