Better Data, Better Decisions: Why We Need to Connect Clinical and Drug Safety

Jan 27, 2026 | Gianfranco Scibelli

Today, a simple and vital task like turning serious adverse events in EDC into safety cases often requires hours of manual effort between clinical and safety teams. Most clinical and safety teams collect data independently using separate databases, even though they contain common elements. This makes duplicate data processing the norm. Clinical and safety teams are expected to process and reconcile the same data twice.

This siloed approach adds significant time and costs while putting sponsors at high risk of errors. Ultimately, this can lead to deficiencies in regulatory submissions, resulting in major or critical non-compliance. It could even cause a regulator to lose confidence in an applicant’s data quality.

These risks only grow as companies expand their trial portfolios. As SAE volume increases, sponsors may be forced to invest in costly, unscalable EDC to safety integrations. But, an even greater risk is missing key insights. For example, a safety team might miss important information if they only rely on limited data transfers of SAEs from the EDC system without having access to related subject information such as medical history, drug history, test results, or laboratory data.

Connecting technology to improve data quality and mitigate risk

The industry has historically accepted these missed insights and inefficiencies as the cost of maintaining patient safety and meeting regulatory requirements. But, in today’s digital world, this vital effort can be handled more efficiently. Connecting clinical and safety systems for near real-time data flow enables safety teams to quickly and reliably access the clinical information they need for thorough medical assessments. This reduces manual processes, costs, and the risk of other patients suffering from preventable adverse events. “Connected technology helps us innovate and evaluate our business holistically to bring meaningful change to our PV teams,” says Cory Gilbert, senior director of PV operations and global process enablement at Merck.

As clinical teams receive patient information in their EDC system, any SAE data is automatically extracted and sent to the safety system. In parallel, PV teams are also notified of the SAE. There is no need to re-enter clinical data into safety systems, and full traceability from the clinical source data to the safety system output ensures data integrity and can reduce reconciliation.

Inhibrx, a clinical-stage biotechnology company, is prioritizing a simplified and unified safety platform to mitigate risk and improve data quality. “When data is entered multiple times into different systems, it introduces a high risk of human error. Reconciling that data can come at a very high cost. Allowing safety and clinical operations teams to work better together ensures we have distributed our cases to the right people and proves that they received them,” says Bonne Adams, the company’s vice president of operations. As Inhibrx builds on its strong data foundation, Adams hopes to eliminate redundancies across the company’s systems landscape. “I wanted to create an environment where the same piece of data is only entered once in one place and flows through all of our systems to break down those redundancies.”

Cutting serious adverse event processing time

Complex trials in therapeutic areas like oncology typically generate many adverse events per patient. Processing these events can take hours, if not days, especially if the safety team requests additional information during medical review. With thousands of patients enrolled during a clinical development program, the time and cost quickly add up.

When safety teams have direct access to information like lab data and medical history in EDC, they no longer need to send as many queries, cutting case processing and medical review time. After connecting clinical and safety, Inhibrx is expecting “case processing time to decrease by 50% while increasing data accuracy and quality because we’re not doing double data entry from Vault EDC to Vault Safety,” Adams explains.

Building the business case to connect safety and clinical

Automating manual processes requires better connections between the EDC and the safety database. The approach will differ for every company depending on its infrastructure. If a company uses siloed systems from different vendors, a gateway approach leveraging the E2B(R3) industry standard for transmitting individual case safety reports can help map and transfer parts of the data across systems. However, limitations of the E2B standard mean customizations or workarounds are still necessary to transfer the additional information often required for proper case processing.

Adopting EDC and safety systems, seamlessly connected on the same platform, can automate bidirectional information sharing between clinical and safety teams. In a shared platform, all routinely required data is captured from EDC and turned into cases within the safety system. Additional safety-relevant information from EDC is readily available for the safety team and can be pulled into cases during medical review.

Clinical teams can also track safety case status to reduce the risk of delays in database lock. Gilbert is bringing Merck’s systems together to streamline processes: “We’ll connect clinical data directly into our safety database, reducing multiple data entries and making our processes more efficient.” Automating data flow improves data quality and consistency while ensuring safety teams and working from the most current, trusted information.

Connecting clinical data and safety systems on a common platform can:

• Remove the need for elaborate data reconciliation
• Reduce time spent by site personnel on administrative tasks
• Eliminate the cost of maintaining and upgrading home-grown integrations
• Reduce errors and inconsistencies in regulatory submissions
• Speed up case processing and medical review
• Decrease the risk of delays in clinical database lock
• Increase patient safety

Fueling innovation with comprehensive and reliable safety data

Now that safety leaders are seeing the limits of disconnected solutions, sponsors are looking to standardize and simplify their system landscapes. “Being willing to adopt tech and take advantage of new solutions is crucial. Our partnership with Veeva allows us to stay at the forefront of technological advancements in the industry. We are now streamlining our operations and improving efficiency,” says Adams.

As trials and therapies become more complex, simplifying and standardizing systems across clinical and safety will help sponsors better address patient needs. Eliminating the manual data entry and reconciliation required to process SAEs will help clinical and safety teams focus on patients and science.

Read how top sponsors are streamlining processes with unified and connected safety.

See how sponsors are automating the flow of information between clinical data management and safety systems.