How Protiviti helped pharmaceutical giant improve clinical trials

⇨ A biopharmaceutical company's ability to access real-time data during clinical trials is crucial for effective performance and patient safety.

⇨ Partnering with Protiviti allowed the company to enhance data management processes and integrate disparate systems, improving traceability and compliance with regulations like the US Physician Payment Sunshine Act.

⇨ By using SAP HANA's in-memory database for data modeling, the company achieved improved efficiency in reporting and inventory management throughout the clinical trial cycle, enabling better decision-making and reduced waste.

For a global biopharmaceutical company, which develops, manufactures and distributes medical therapies to treat patients with serious and life-threatening medical conditions, the ability to access data when and where needed can affect not only its performance but its capacity to save lives. 

As the company conducts clinical trials to better understand the effectiveness of pharmaceutical and medical treatments, it tracks multiple variables from disparate systems. These systems can include which medications are being tested, how many sites are conducting clinical trials, which patients need to be placed in or removed from a trial and how much of a medication needs to be manufactured at a given time.

Managing the clinical trial process

These requirements mean that a loss of data visibility at any point in the clinical trial process can have a serious impact on the outcome of a trial and can even invalidate a trial if a patient misses a dose. For this reason, the company uses several systems to track variables, gain insights and manage the process, including a clinical trial management system, SAP ECC (Enterprise Central Component), SAP S/4HANA, SAP BW on HANA and multiple Interactive Response Technology (IRT) systems.

Recently, as the company sought to reduce unnecessary manual effort and gain traceability of critical data, it partnered with Protiviti to improve its data management and analytics processes, as well as comply with the US Physician Payment Sunshine Act.

In addition, the company also looked to integrate data from its disparate systems and produce visual reports showing the end-to-end clinical trials supply process, including planned vs actual enrollments, supplies and production of medication, as well as traceability of data between systems and financial data to comply with the Physician Payment Sunshine Act.

Clear view into the future with virtual layers 

As the biopharmaceutical company was already using SAP HANA’s in-memory database, Protiviti steered the modeling of data in a virtual layer on HANA to eliminate the need to duplicate or store data, reducing storage costs and creating efficiency in reporting, while allowing for quicker development time and easier maintenance.

From there, using its SAP technology expertise and understanding of clinical trial methodology and structure, the project team enabled the organization’s leadership to evaluate and refine difficult requirements to better align with the company’s processes.

As a result of this method, the data management, analytics and reporting solution allows the company more visibility into its inventory throughout the clinical trials cycle. Clinical trial managers can know when and where a medication is in the pipeline, see stock levels at a clinical trial site, and know if a medication is nearing its expiration date and needs to be replaced. The system’s design also allows it to evolve as the company’s needs change to provide access to even more information.

This collaboration highlights how updating a company’s data handling process, especially when working with critical information, can reshape the daily operations of the organization with better tracking and less waste of clinical trial medications, while leaving space for evolving as time progresses.