Written for Veeva Systems
Patients rely on CSL Behring therapies for their quality of life and, in many cases, for life itself. The company specializes in researching, developing, manufacturing and marketing biotherapies to treat serious and rare medical conditions. CSL Behring makes 41 products in Switzerland, Germany, Australia, and the U.S. Unlike conventional pharmaceuticals, biotherapies are derived from human blood plasma or made using recombinant technologies.
A few years ago, the CSL Behring operations group realized that, to bring life-saving treatments to market faster, with fewer errors and better compliance, it needed an electronic trial master file (eTMF) system to replace paper-based processes.
CSL Behring – At a Glance
Corporate HQ: King of Prussia, PA
Locations: Operates in 28 countries
12,000 Employees Worldwide
Specialty Care Areas: Immunology, Critical Care, Plasma-Derived Coagulation, Recombinant Factor VIII
The Demand for Better Processes
For years, CSL Behring tracked its clinical trial processes with a massive number of paper documents and logged every document on spreadsheets. To control this unwieldy system, the clinical operations group outsourced its TMF to contract research organizations (CROs) and data management firms.
“Because we outsourced to so many vendors, internally we had only pieces of our TMF available for review,” said Brendan Smith, clinical operations director at CSL Behring. “We decided we didn’t want to rely on a group of external folks to manage our TMF—we wanted internal knowledge of everything in our master file. We’re doing 20% more clinical studies than one year ago—all with paper documents—and we’ve had serious challenges trying to stay efficient and maintain visibility of the process.”
Quality control was also an issue. With paper-based methods, efforts to ensure the completeness and accuracy of clinical trial documents were performed on each document as it was uploaded into the internal database. Quality control was a shared responsibility among the operations group and, as the volume of studies and documents increased, it consumed large amounts of staff time.
The CSL Behring operations team needed a system that provided:
Centralized, global access to all clinical trial documents
The ability to perform quality control of the entire TMF at one time and instantly alert the team about incomplete, missing, or inaccurate files
A faster overall clinical trial process to get life-saving drugs to market faster
An efficient vendor management tool that keeps vendors accountable by observing when they upload documents into the system and sending notices for missed deadlines
Flexibility to configure the eTMF to fit their unique needs and collaborate effectively with external sources while maintaining visibility of all documents
Finding the Answers
“Our entire clinical trial process is faster and more accurate because of Veeva Vault eTMF.”
- John Smith, clinical operations director
After performing a thorough search for the right eTMF system, CSL Behring chose an on-premise solution that was cost-effective. The team soon realized, however, that it was inflexible and couldn’t be configured to meet their needs. They decided to evaluate Veeva Vault eTMF.
“We liked Vault eTMF’s extensive flexibility,” said Janice Harrier, operations manager at CSL Behring. “We were able to mould it exactly how we wanted. For example, the system would allow us to assign our internal users to different roles for different tasks and let us track their progress in the system. Because of this flexibility, Vault eTMF allowed us to remodel our clinical trial process exactly as we needed to rather than force-fit our process into an inflexible technology.”
The completeness of Vault eTMF was vitally important to the CSL Behring team. Since regulatory bodies need a comprehensive, accurate TMF for a proper review, it’s best for an operations team to be check the entire eTMF when all global trials are initiated and again when the last trial is completed, instead of reviewing hundreds of paper documents on a huge spreadsheet multiple times.
Since the company that supplied the on-premise system to CSL Behring was slow to implement its solution, the fact that Veeva promised fast implementation was an important factor in CSL Behring’s decision to go with Vault eTMF.
Better vendor management
Greater process efficiency
Improved quality control
Easy document access
After Veeva implemented the complete Vault eTMF solution, CSL Behring went live with the system in July 2014 for two clinical trials involving more than 3,500 documents. CSL Behring realized these benefits from choosing Vault eTMF:
“One of the biggest advantages of partnering with Veeva was the short time to go-live—Veeva implemented the entire system in eight weeks,” said Smith. “The team from Veeva was very organized and they moved implementation forward quickly without burdening our internal IT department. We were impressed with the process—Veeva configured the system, held workshops to train our staff and stayed within our timeline.”
Because Vault eTMF is a centralized system, it allows the operations group to collaborate more effectively with clinical study stakeholders—both internal and external—while maintaining complete visibility. When the system went live, it immediately brought CROs into the system and began monitoring outsourcing.
Better Vendor Management
Before Vault eTMF, the CSL Behring operations group was hindered by delays in receiving documents from external vendors—often waiting 3-6 months for documents after a site initiation visit (SIV). Leveraging the increased visibility of Vault eTMF, the operations team now observes when vendors upload documents into the system and sends notices that hold vendors accountable for missed deadlines.
Greater Process Efficiency
“Now that we have easy, centralized access to the eTMF, staff members can physically complete and upload documents into the system themselves, which allows better staff compliance in submitting content,” said Harrier. “The system has improved efficiency because it puts responsibility on document owners, which removes tasks from people in management positions.”
Improved Quality Control
The operations group now performs quality control—which used to be a shared, paper-based process among different groups—completely in Vault eTMF. The solution allows the team to easily observe whether documents are filed correctly and catch problems sooner, ensuring greater consistency. The standardization provided by the system makes it easier for the CSL Behring team to comply with the DIA Reference Model for organizing data and documents, which means fewer documents are rejected, time is saved, and user acceptance is increased.
Easy Document Access
A global company such as CSL Behring benefits from the fact that Vault eTMF gives stakeholders around the world a single source for accessing any research-related document. “Our clinical trial operations process used to be very fragmented,” said Smith. “We outsource many functions and each vendor maintained their piece of information. Vault eTMF contains and maintains all internal documents as well as vendor documents, so we don’t have to be concerned about vendors that haven’t given us their files. Our entire clinical trial process is faster and more accurate because of Veeva Vault eTMF. ”
After adopting Veeva Vault eTMF, CSL Behring achieved higher scores on the Veeva TMF Maturity Model assessment. The TMF Maturity Model is a complimentary consultative service that assesses the state of a life sciences organization’s trial master file (TMF) and provides a practical, step-by-step roadmap for improvement.
Currently, CSL Behring uses Veeva Vault eTMF as a document repository, but the ability of Vault to transform the company’s processes has prompted the operations team to consider future clinical trial improvements. “We have process-level discussions that weren’t possible before Vault eTMF,” said Harrier. “The system gives us the flexibility to continue evolving as an organization. We’re starting to dream about all the things we can implement with this technology and there are so many that it’s hard to decide which one to pursue first.”