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Clinical Trials Management

Clinical Trials Management

Improving the quality and diversity of candidates selected for clinical trials.

Context & Challenges

The current clinical trials management process is increasingly complex — spanning many stages, multiple geographic locations, various third-party vendors, data collection methods, and timelines. At present, this process lacks transparency and trust, making it difficult to manage data along the way and protect the integrity of the data collected.

For clinical trials, Contract Research Organizations (CROs) are responsible for managing the adjudication information of various trials, often at multiple clinical sites, all while preserving the anonymity of the trial patients. This process is laden with heavy confusion and disagreement about the data being sent and received, often caused by the inability to determine the most recent and accurate clinical trial data. This contributes to why patient recruitment, retention and monitoring account for up to 30% of a clinical trial’s total cost.

Additionally, there are various intermediaries that slow down the entire clinical trial process, from patient recruitment to publication of results. Managing this process, from study design to patient tracking, utilizing manual paper-based processes makes transparency difficult. This fragmented and trustless tracking system makes it challenging for stakeholders to gain accurate insight into the total process flow, while seeking real-time data in order to meet accountability and authenticity requirements.

STRATO Mercata provides a unified workflow and more reliable data to choose patients more likely to adhere to the clinical trial protocol.

Solution Benefits

Clinical trials management on STRATO Mercata provides the following benefits:

—  Faster, reliable agreement on adjudication data

—  Fewer trials rejected due to paperwork issues

—  Stronger patient data protection

—  Improved trial efficiency and scale for clinical sites

—  Digitization of and automation of manual processes with smart contracts

—  Enhanced integrity of trial design due to smart contracts preventing parameters from being changed

—  Single source of truth for patient data

—  Reduced latency for transaction approval

—  Compatible with HIPAA requirements

—  Real-time tracking capabilities

—  Highly API-extensible platform