Managing Clinical Studies Through European Holidays
PPD® Biotech’s Samantha Hadfield, senior director of project management, Helen Dunlop, director of project management, and Rania Laguel, director of project management, provide suggestions on preparing your study for the summer holidays in Europe.
Whether a global or regional European Union (EU)-only trial, the tradition of Europeans taking extended holidays in June, July and especially August presents a problem in terms of a gap in drug development resources for studies conducted in Europe. This is, of course, always forecasted for, but it can still be a source of challenges. However, rather than accepting it as problem that can be addressed only by accounting for delays, the PPD®Biotech team utilizes robust processes and global resources to continually improve management of this challenge and keep projects on track.
With summer holidays once again on the horizon, the PPD Biotech project management team takes a look at three factors that help you maximize trial progress during the next few months.
Coordination and communication
Close coordination and communication among the client, contract research organization (CRO) and sites play an important role in overcoming the challenge of summer vacations. It is critical that communication and planning for the summer gap begin at least by May of that year. Top considerations from the perspective of each of the key players are below.
Communication from the CRO
- Ensure clinical research associates (CRAs) discuss backup plans with sites, along with project managers
- Assist sites in scheduling patient visits
- For example, if a patient is randomized in late July, we proactively consider when the next visit per protocol is due and whether this is impacted by vacation of patients, staff or facilities. In such cases, we provide sites with custom planners or visit calculators to help minimize the impact on enrollment and prevent possible protocol deviations for out-of-window visits.
- Understand schedules of all sites to maximize utilization of available resources
- Connect with central lab teams to coordinate schedules of central labs, couriers or any related vendors
It is important to remember that many sites will be operating on skeleton clinical research teams, so clear instructions and easy access to PPD support are extremely valuable.
- Drug supply dates need to be carefully set and met
Investigator site actions
- When investigators or key contacts are on vacation, establish backup points of contact
Leveraging a global workforce
The ability to take advantage of a global workforce is also beneficial. Being a global company, we are also able to rely on staff in other regions. We have the ability to plan for and move work where team members are available. If a study is multiregional, we plan for this by putting additional effort into recruitment in other regions and work with team members outside of Europe to proactively address any study issues while the Europe team has reduced bandwidth.
Robust processes for returning staff
Finally, as part of our planning in May, we fully map out when team members are returning and systematically get them up-to-speed in “hand-back” meetings, where we brief them on trial status.
Teams maintain study information in PPD systems and tools such as PPD® CTMS, a clinical trial management system, and returning staff can navigate with ease via Preclarus® to catch up with the latest metrics. Areas of interest are highlighted to them through automated triggers and they are never hampered by a need to trawl through oppressive spreadsheets.
Additionally, as important as it is to be proactive in mitigating the resource lag during the summers in Europe, realistic estimations of a dip in productivity must still be estimated in planning. After all, heightened workload for those covering for vacationing colleagues can leave them overburdened. For returning employees, it will take some time to catch up after their vacation.
Knowledge of country-specific holidays and planning around them makes all the difference. If you organize things carefully and respect the needs and priorities of staff, many of them will go out of their way to accommodate requests during any absences.
Samantha Hadfield is a senior director in project management, PPD Biotech, Helen Dunlop is a director in project management, PPD Biotech, and Rania Laguel is a director in project management, PPD Biotech.