Characteristics of a Scalable Real-world and Clinical Trial Data Linkage Solution

Data linkage is a cutting-edge innovation that unlocks a new frontier of enhanced evidence generation by linking clinical trial data (CTD) with real-world data (RWD) at the patient level.

Pharmaceutical companies seeking to build infrastructure for data linkage must make decisions early on to avoid pitfalls that can limit scalability and hinder evidence generation. In order to create infrastructure that can scale, data linkage solutions must be CRO agnostic, support flexible Personally Identifiable Information (PII) ingestion, create multiple token schemas, and be privacy certified.

CRO Agnostic

When building an infrastructure for clinical development, sponsors must ensure their trusted data linkage solution works regardless of which CRO runs the clinical trial. Working independently with a CRO often leads to one-off, custom-built solutions forcing sponsors to start from scratch for each trial run by other CROs. The optimal approach is a data linkage solution that is fully CRO agnostic and can scale across trials run by different CROs.

Scalable PII Ingestion

To build a scaled data linkage infrastructure, solutions must be compatible with flexible PII ingestion. For example, data linkage solutions must allow for site-based PII capture, patient-submitted PII forms, and file transfers from CROs or third-party vendors within a centralized environment. Perhaps the most important facet of scalable PII ingestion is a single, site-facing tool embedded into the normal clinical workflow that can be deployed across sites.

Multiple Token Schemas

To truly maximize the potential of RWD capture, sponsors must be able to create multiple token schemas. Using a central environment to generate multiple tokens gives sponsors access to the largest pool of RWD to link to clinical trial patients, increasing the likelihood of finding matches. Also, a centralized workflow that can create multiple tokens avoids the need to install tokenization software at every site, an inefficient, time-consuming, and expensive process.

Secure, Privacy Certified Environment

Working with linked CTD and RWD presents an increased risk of re-identification and privacy breaches. Successful sponsors steer clear of the risks of directly holding PII and ensure linked RWD-CTD is HIPAA certified by privacy experts, guaranteeing that only certified data is transferred to sponsors. Rather than holding PII, sponsors can strategically partner with neutral third parties who can build the complex engineering pipelines and secure infrastructure needed. This way, sponsors and data science teams can access the data while minimizing the risk of re-identification and privacy breaches.

About the Medidata Acorn AI Advantage

Medidata Link is a solution that allows sponsors to link RWD to CTD at the patient level in a single workflow integrated into normal trial operations. It offers the only centralized, CRO-agnostic solution that supports multiple token schemas with access to an expansive ecosystem of RWD covering over 330 million lives and 100 billion patient records. Acorn AI is a long-term partner with unrivaled analytics expertise to harmonize and analyze CTD with RWD, bridging evidence gaps to save sponsors time and increase confidence in decision-making.

Discover how Medidata Link can enhance evidence generation activities.