The life sciences industry is facing mounting pressure to accelerate clinical trials while managing exponentially growing data volumes. According to recent industry surveys, the volume of data in phase 3 studies has increased by more than 50% since 2000, with per-patient costs nearly doubling during the same period.
Behind this concerning trend lies a fragmented technology landscape that has evolved piecemeal over decades. Most clinical teams now operate with 20 or more non-integrated systems to manage global trials—from electronic data capture (EDC) and study start-up applications to clinical trial management systems (CTMS) and electronic trial master files (eTMF).
The High Cost of Fragmented Systems
The consequences of this fragmentation are severe. A survey of 300 clinical operations professionals revealed that 99% recognize the need to unify their clinical applications. The average organization uses at least four different applications to manage clinical studies, with 38% using five or more.
"The clinical development process is highly inefficient due to a number of factors, including the inconsistent use of a large number of incompatible technologies," said Ken Getz, associate professor at Tufts University School of Medicine and chairman of the Center for Information and Study on Clinical Research Participation.
This disjointed approach creates significant process inefficiencies. Study managers typically export data from CTMS and EDC systems only to manually compile them into central spreadsheets. Site staff spend excessive time maintaining and tracking clinical data across multiple platforms. The survey found that 69% of respondents cited integrating multiple applications as their top challenge, followed by reporting across applications (61%).
CTMS Systems Falling Short
Nearly all sponsors (98%) reported challenges with their current CTMS applications. The most common deficiencies include:
- Tracking and reporting limitations (38%)
- Poor integration with eTMF applications (37%)
- Inadequate integration with EDC applications (37%)
- Inability to support resource management (77%)
- Limitations in study and site feasibility functions (76%)
- Insufficient financial management capabilities (75%)
- Inadequate issue/task management (73%)
Monitoring was the only process most sponsors (54%) felt their CTMS applications supported adequately.
The Promise of Unified Clinical Platforms
Industry experts suggest that unifying clinical applications on a single platform could dramatically improve efficiency. By bringing documents, data, people, and workflows together, organizations could potentially reduce a typical 26-step clinical process by as much as 60%, down to just 8 steps.
"The integration of clinical practice and clinical research data, next-generation e-clinical technology solutions that unify end-to-end clinical processes, and improvements in protocol design execution feasibility will all be critical success factors in driving higher levels of efficiency, performance, and data quality," stated Getz.
The top three drivers for unifying clinical applications cited by survey respondents were:
- Faster study execution (65%)
- Improved study quality (63%)
- Cost savings (59%)
Progress Toward Digital Transformation
The industry is making progress in some areas. The adoption of purpose-built, "active" eTMF applications has more than doubled since 2014, with one-in-three sponsors (31%) now using these solutions. Organizations using active eTMF applications report significant improvements in inspection-readiness, automated tracking and reporting of documents (68%), central and remote auditing (62%), and visibility into key study performance metrics (50%).
Paper usage is also declining substantially. Across almost all functional areas, the number of TMF documents managed on paper has decreased by at least half among sponsor companies since 2014. Clinical operations departments led this transition, with just 16% of sponsors reporting that "most-to-all" of their TMF documents were paper-based—a 25% reduction since 2014.
Collaboration Challenges Persist
Despite these advances, collaboration with external partners remains problematic. More than two-thirds of sponsors (68%) still use email to exchange TMF documents with contract research organizations (CROs), while only 19% leverage their eTMF applications for this purpose. This reliance on email places critical information outside controlled processes, making tracking and collaboration inefficient.
Henry Levy, chief strategy officer at Veeva Systems, noted: "The industry has been forced to settle for clinical data management systems that have been short on innovation and high on complexity. It needs data quality and real-time access to make faster, informed decisions and cut the cost and complexity of trials."
Data-Driven Process Improvement
The survey revealed that many organizations are not fully leveraging available data to improve their processes. One in four respondents (23%) reported rarely or never using data to improve study processes, while roughly half (46%) only used data in some cases.
However, organizations that collect and utilize more data report greater improvements in audit readiness, collaboration, and monitoring activities—suggesting that data-driven approaches are key to optimizing clinical operations.
Overcoming Implementation Concerns
Despite the clear benefits, many organizations hesitate to replace legacy systems due to business continuity concerns. Executives worry that custom integrations between existing systems might fail during technology transitions.
However, proponents of unified platforms argue that cloud-based solutions eliminate the need to manually move operational data and documents between systems. With a single platform, the most up-to-date information appears automatically across applications with the correct metadata in real time, increasing visibility, accuracy, and accessibility.
The Path Forward
As clinical trials continue to grow in complexity and scale, the industry appears to be reaching consensus on the need for unified clinical operations. Organizations that adopt modern, purpose-built applications report fewer challenges and greater benefits to their studies.
When unified, these applications enable life sciences organizations to establish repeatable, collaborative processes and increase oversight by consistently leveraging insights across their clinical portfolios—ultimately accelerating the delivery of innovative therapies to patients while controlling costs.
