Precise, repeatable evidence – the foundation of a successful trial
ARANZ Medical’s Silhouette provides increased levels of precision, risk mitigation and efficiency in every aspect of evidence collection for clinical trials. Silhouette has revolutionized data collection in clinical trials and has proven itself as the gold standard in clinical research.
Silhouette is an accurate wound imaging, 3D measurement and data analysis system and is the leading electronic wound assessment system for clinical wound research, proven during more than 70 major clinical trials, many with multiple international investigator sites. It has gathered the evidence for successful FDA approvals, significant funding phase progressions, and studies published in leading international publications.
Endpoints are the key variable revealing the efficacy of a clinical trial’s investigational product, yet:
Without comprehensive and transparent reporting the credibility of research suffers.
Unless a sponsor or CRO designs a study that can prove the endpoint/s as quickly and definitively as possible, errors and inefficiencies can jeopardize the primary endpoint evidence, and therefore the entire basis for the trial.
Monitoring and the management of data and statistics can cost up to one-third of a large trial’s cost.
Without the Silhouette® wound assessment and management system, clinical trial data-gathering is logistically complex:
A sponsor marshalls a fleet of investigators across multiple sites to meticulously follow a protocol.
A flood of assessment data is collected.
The wound assessment data should be available instantly, to minimise subject loss, timely assessment of subject inclusion & exclusion, and to prevent tainting of evidence, however many other data collection and analysis methods involve delays of days or even weeks.
Compromised data could lead to the collapse of a site, or even of a sponsoring company, and because of these data issues a product that could have made a difference to many lives may never see the light of day.
Silhouette enables accurate, repeatable wound trial information to be collected by investigators and become instantaneously available to the sponsor or CRO. It gathers the necessary evidence to prove trial endpoints and make defensible cases for regulatory approval.
Three good reasons to use Silhouette to gather wound assessment evidence for your next clinical trial:
Silhouette mitigates the risk of inadequate documentation, shepherding the data from each investigator site into a single online resource that can form the basis of all monitoring and auditing activity, and become the evidence base for any subsequent regulatory approval application, article, or progress report.
Silhouette increases the efficiency of data collection and investigator oversight, through bringing data instantly to a central repository that is immediately accessible by sponsors, CROs, and other management stakeholders.
Silhouette’s assessment data is precise and repeatable, providing credible, high quality data to prove the study’s endpoints.