Veeva Systems06.19.19
According to the Veeva 2019 Unified Clinical Operations Survey, there is an industrywide drive to streamline trial processes and systems for better study visibility and collaboration. The survey, which examines the life sciences industry’s progress toward a unified clinical environment by gathering the experiences and opinions of 461 clinical operations professionals from around the globe, found that 100% of respondents report the need to improve information exchange among study partners.
On average, respondents utilize at least three methods to share trial data and documents among sponsors, CROs and sites, with email as the primary tool. Majorities said that the move to streamline information exchange is driven by the need to reduce manual processes (71%), improve collaboration (66%) and increase visibility and oversight (64%) during trials.
Nearly every sponsor and CRO (99%) said they need clinical applications to be unified for greater visibility (70%) and easier collaboration (61%). Many of the challenges in managing trials stem from siloed processes and systems that prevent a complete view of study progress and slow trial execution. Integration (68%) and reporting (57%) are the top two issues cited – both are the direct result of clinical system silos.
Improving Study Start-up to Speed Trial Execution
Study start-up is one of the clinical areas with the most potential to improve trial efficiency and speed. All respondents reported significant challenges with study start-up, likely due to its heavy reliance on manual processes since 81% use spreadsheets to manage this area.
Sponsors and CROs are increasingly adopting purpose-built study start-up applications to speed cycle times. Nearly one-quarter (23%) of respondents are now using newer, purpose-built study start-up applications.
Findings show that the majority of respondents cited faster study start-up times (71%) as the primary driver to improve study start-up processes. 50% of respondents said easier collaboration during study start-up is also an area in need of improvement, highlighting the importance of collaboration in driving clinical trial efficiency and speed.
Steady Adoption of Advanced Clinical Applications
Over the past several years, sponsors and CROs have been steadily adopting function-specific applications to improve study execution. The industry is already modernizing its processes and systems in major clinical areas such as eTMF and are seeing a positive impact. Sponsors and CROs, however, reported challenges in other areas such as CTMS because of the prevalence of legacy systems.
Nearly all respondents (95%) said the use of CTMS in clinical operations could be improved. For most, better analytics and reporting (68%) and increased visibility (60%) are among the primary reasons. Roughly half of sponsors and CROs (48%) also said easier collaboration is a top driver, underscoring the importance of streamlining communication and information sharing during execution.
The number of respondents using purpose-built eTMF applications has tripled since 2014. At the same time, the use of general-purpose methods to manage TMF processes has decreased, indicating the continued move away from TMFs that act as static repositories to store and archive documents upon completion to modern purpose-built eTMF applications that enable more ‘active’ trial management. Those using purpose-built eTMF solutions reported an improved ability to maintain a constant state of inspection-readiness (60%) and visibility into TMF status (58%).
“There is a significant industrywide opportunity to improve study visibility and partner collaboration to speed trial execution,” said Jim Reilly, vice president of Vault Clinical. “As more sponsors, CROs, and sites focus on streamlining clinical processes and systems, drug development will become more efficient and stakeholders will be better aligned throughout the trial lifecycle.”
The full results of the Veeva 2019 Unified Clinical Operations Survey will be presented at the DIA 2019 Annual Meeting on June 24 at 1:00 p.m. in Innovation Theater 1 in the exhibit hall. The full report is available online at veeva.com/ClinicalSurvey.
On average, respondents utilize at least three methods to share trial data and documents among sponsors, CROs and sites, with email as the primary tool. Majorities said that the move to streamline information exchange is driven by the need to reduce manual processes (71%), improve collaboration (66%) and increase visibility and oversight (64%) during trials.
Nearly every sponsor and CRO (99%) said they need clinical applications to be unified for greater visibility (70%) and easier collaboration (61%). Many of the challenges in managing trials stem from siloed processes and systems that prevent a complete view of study progress and slow trial execution. Integration (68%) and reporting (57%) are the top two issues cited – both are the direct result of clinical system silos.
Improving Study Start-up to Speed Trial Execution
Study start-up is one of the clinical areas with the most potential to improve trial efficiency and speed. All respondents reported significant challenges with study start-up, likely due to its heavy reliance on manual processes since 81% use spreadsheets to manage this area.
Sponsors and CROs are increasingly adopting purpose-built study start-up applications to speed cycle times. Nearly one-quarter (23%) of respondents are now using newer, purpose-built study start-up applications.
Findings show that the majority of respondents cited faster study start-up times (71%) as the primary driver to improve study start-up processes. 50% of respondents said easier collaboration during study start-up is also an area in need of improvement, highlighting the importance of collaboration in driving clinical trial efficiency and speed.
Steady Adoption of Advanced Clinical Applications
Over the past several years, sponsors and CROs have been steadily adopting function-specific applications to improve study execution. The industry is already modernizing its processes and systems in major clinical areas such as eTMF and are seeing a positive impact. Sponsors and CROs, however, reported challenges in other areas such as CTMS because of the prevalence of legacy systems.
Nearly all respondents (95%) said the use of CTMS in clinical operations could be improved. For most, better analytics and reporting (68%) and increased visibility (60%) are among the primary reasons. Roughly half of sponsors and CROs (48%) also said easier collaboration is a top driver, underscoring the importance of streamlining communication and information sharing during execution.
The number of respondents using purpose-built eTMF applications has tripled since 2014. At the same time, the use of general-purpose methods to manage TMF processes has decreased, indicating the continued move away from TMFs that act as static repositories to store and archive documents upon completion to modern purpose-built eTMF applications that enable more ‘active’ trial management. Those using purpose-built eTMF solutions reported an improved ability to maintain a constant state of inspection-readiness (60%) and visibility into TMF status (58%).
“There is a significant industrywide opportunity to improve study visibility and partner collaboration to speed trial execution,” said Jim Reilly, vice president of Vault Clinical. “As more sponsors, CROs, and sites focus on streamlining clinical processes and systems, drug development will become more efficient and stakeholders will be better aligned throughout the trial lifecycle.”
The full results of the Veeva 2019 Unified Clinical Operations Survey will be presented at the DIA 2019 Annual Meeting on June 24 at 1:00 p.m. in Innovation Theater 1 in the exhibit hall. The full report is available online at veeva.com/ClinicalSurvey.
