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No clinical trial goes exactly as planned, and most will experience obstacles during startup and execution. Proper operational expertise provides a solid foundation from which to build a well designed, budgeted, and quality oriented clinical research program.
A significant portion of trials are still clearly losing sight of their goals, which demonstrates a tangible need for effective operational support. Operations provides the ability to select a proper CRO and supportive vendors, establish a realistic budget, timeline, and plan to ensure proper checks are in place to have confidence in trial management, quality, and data integrity throughout the duration of the clinical trial. Together we are able to foster transparency and collaboration around reasons for trial under performance, keeping them in plain view, and develop effective actionable solutions to reduce the number of clinical trials that go off the rails due to Operational Failure.
Have you experienced any of the following?
- Enrollment behind schedule
- Uncertainty in which CRO is right for your company and trial
- Underperforming sites
- Not sure which metrics you should or shouldn't pay attention to
- Numerous change orders
- Not sure what questions to ask a prospective CRO during the RFP process
- Unsure if there are study issues you should be concerned about and whether the CRO is managing the study effectively
- Data entry behind
- Monitoring visits gone over the projected # of visits
- Site budgets not what the CRO promised in their pass thru proposal
- Do the study plans make sense for my trial?
Mindset Clinical Operations can help you overcome all of these obstacles and more
The Case for a Holistic Approach to Transforming Clinical Trials
https://www.iconplc.com/insights/transforming-trials/improving-pharma-research-and-development-efficiency/ The Case for a Holistic Approach to Transforming Clinical Trials
A new survey of pharmaceutical executives and professionals by ICON and Informa Pharma Intelligence, supplemented by desk research conducted by ISR Research, provides valuable insight into key clinical research challenges and potential solutions for clinical development.
We explore the key challenges, and those areas identified by industry experts as having the most potential for generating savings and improving clinical trial efficiency, and how digital disruption is forcing change.
Adopting individual initiatives and tactics can improve clinical trial efficiency, but the potential is even greater when they are applied in a coordinated fashion to reimagine and reinvent the R&D enterprise.
Whilst our survey shows that companies realise the need for a holistic effort to transform trials, only one in five survey respondents stated their organisation currently has a holistic/integrated approach to drive clinical trials transformation. In too many organisations, efforts remain siloed and therefore potentially not delivering their full potential for full process efficiencies and economic value.
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