The management time needed to corral many different elements during a trial is immense. In the buildup to a research study, clinical operations teams often focus on items such as study startup, site initiation and activation, supply chain, monitoring, data management, and safety. And there is so much more! Finding ways to improve clinical trial efficiencies leads to an easier-to-manage study.
Some key site needs and patient engagement components that need to be managed include:
Also, consider complicating factors, such as:
- The growing global footprint of clinical studies
- The evolution to a decentralized clinical trial model
- The importance of considering health literacy in educating potential study volunteers, their caregivers, and stakeholders
- The need to drive greater diversity in clinical trials
More responsibilities
In addition to managing all the different elements of a research study, clinical trial project managers are saddled with overseeing as many as eight different vendors, when considering the list of services above. Therefore, they often find two more titles added to their job description:
- Project manager
- Vendor manager
That’s up to eight separate vendors, all with unique requirements culminating in the need for numerous meetings, people, and timelines. Management can be highly complex and disruptive, and wreak havoc on study timelines. These elements are also outside the core competencies of many CROs and sponsors.
The failure to identify, plan for and synchronize these elements accounts for holes that far too many study teams miss. This leads to unexpected delays and headaches.
Interconnection of individual components
How something is written impacts translation. Writing clinical trial content with translation in mind ensures the source text is unambiguous and easy to read. Improved English text also makes it easier to translate, which saves time and money, avoids errors, and improves readability.
During translation, 20-25 percent (even up to 35 percent in some languages) of text expansion can occur, which impacts formatting. 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. One vendor may not know when they will receive files from another vendor to keep the project moving forward. This creates issues with resource planning and time management.
Translators need to know when they will receive files from writers. The layout and formatting vendor needs to know when they will receive the translated files. The printer needs to know when they will receive the formatted print-ready files and so on. This takes up personnel time to communicate with each vendor and time to physically move files from one vendor to another. Then, if there are amendments or other changes, the cycle starts all over again.
Opportunities to improve clinical trial efficiencies
What if all these pieces could be managed together? Combining as many services as possible with one vendor can alleviate the pain and create clinical trial efficiencies.
The activities I’ve listed need to be considered as a single workstream. When placed into a single workflow and taken together, they can result in a powerful platform for awareness building, education, outreach, engagement, and support.
Doing so gives study managers tremendous visibility and allows for centralized control over the quality, speed, and cost. Furthermore, it recognizes that these functions are critically linked and that the quality and approach to work on one directly impacts the others.
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. All the above-listed pitfalls are pre-planned for and taken care of behind the scenes to provide our clients with a smooth, hassle-free process.
Whether creating a single workflow for your study or managing just one essential part, Imperial is ready to help create clinical trial efficiencies.