Discover how to boost clinical trial management efficiency and minimize pain points for your next clinical study.
The Complex Landscape of Clinical Studies
The management hours required to oversee the many components of a clinical trial are substantial. Clinical operations teams typically concentrate on several key areas, including study startup, site initiation and activation, supply chain management, monitoring, data management, and safety.
Key site needs and patient engagement components that need to be managed include:
- Clinical study and site materials, including graphic design and writing
- Clinical translation management
- Printing
- Procurement and management of ancillary clinical trial supplies and equipment
- Kitting
- Warehousing
- Global logistics, including shipping materials and equipment internationally
- Digital and video projects, including websites, apps, and patient videos
The growing global footprint of clinical studies, the evolution to decentralized clinical trial models, and the importance of health literacy and diversity in clinical trials further complicate this landscape. Not to mention more recent geopolitical factors, from border tightening to tariffs. Together, these factors create a highly complex and demanding environment that requires efficient management to ensure successful outcomes.
Challenges of Managing Multiple Vendors
In addition to managing many elements of a research study, clinical project managers must often oversee up to eight vendors, each with unique requirements. This calls for numerous meetings, team members, and timelines, and makes management highly complex and potentially disruptive to study timelines.
The failure to identify, plan for, and synchronize these elements can lead to unexpected delays and headaches. Managing multiple vendors is outside the core competencies of many CROs and sponsors. This can further exacerbate these challenges and create a need for more efficient solutions.
Interconnected Dependencies in Clinical Trials
The interconnected nature of the individual components of clinical trials means that each element impacts the others. A good example is that the way something is written affects its translation. Writing clinical trial content with translation in mind proactively ensures the source text is clear and easy to read, making the translation process more efficient, thus eliminating the potential for system-induced errors.
Text expansion during translation is often 20-25% (even up to 35% in some languages), which impacts formatting. Planning for text expansion and contraction during the initial creative design process can prevent formatting issues later. Planning during the initial creative design process can allow for text expansion and contraction without impacting the overall design. Too often, these activities are done in a vacuum. Vendors that need to be in lockstep often are not, which creates issues with resource planning and time management.
The project manager’s challenges in directing multiple vendors with their unique teams and processes are compounded by the always-pressing study timeline, with its numerous requirements, both fixed and nuanced.
Just one piece of the timeline, for example, the translation process, is based on when the writer’s files are ready. Next comes the translation, eventually leading to layout, formatting, and printing. All of this requires seamless communication and the transfer of files back and forth with multiple independent vendors. Then, shipping must be managed, likely to many international destinations.
And speaking of international destinations, the project manager’s timeline is likely to include the unique demands of medical kitting, as well as ancillary supplies and equipment. Complex supply and resupply schedules must be managed across multiple manufacturing and distributor partners and time zones. Having an ancillary supplies partner that differs from an equipment partner and may also differ from a kitting partner means that you must have a central platform to manage, view, and report on all these disparate pieces. A single-vendor solution not only reduces the complication of managing multiple vendors but also reduces risk and boosts clinical trial management efficiency by having complete visibility into the site readiness supply chain at all times.
Vendor Consolidation and Its Impact on Clinical Trial Management Efficiency
The activities I’ve listed, and more, should be redistributed into a single workstream. Combining as many services as possible with one vendor can alleviate the complexities and create clinical trial management efficiency. By managing these pieces together in a single workstream, study managers gain tremendous visibility and centralized control over file versions, quality, speed, and cost.
Vendor consolidation recognizes that the quality and approach to work on one component impacts others. This integrated approach can streamline processes, reduce the need to manage constant communication, and coordinate the different activities among multiple vendors. Fewer meetings!
A Comprehensive Solution
Imperial provides a single vendor, a single point of contact, and a dedicated project manager devoted to staying on top of details and timelines to make your study a success. Whether creating a single workflow for your study or managing just one essential part, Imperial’s comprehensive solution ensures clinical trial management efficiency. By consolidating services, Imperial helps streamline clinical trial management, enhancing efficiency and reducing complexity. Visit our website and contact us for more information.