The biopharma holiday wish list: What to look for in a CRO running trials through the festive season

Choose a CRO with a proven global operational presence 

This allows for anticipation and adaptation to the staggered disruptions that occur across different regions during different holiday seasons. A CRO with decentralized hubs has expertise and experience embedded worldwide – meaning the CRO has real-time insights into regional patterns, cultural norms, vendor schedules, regulatory closures, and logistical constraints. Local teams with 24/7 operational presence can rapidly troubleshoot issues without being constrained by distant time zones or centralized escalation.  

The CRO can coordinate seamlessly across sites, labs, and authorities, all operating under different holiday calendars, to maintain momentum as one region starts to slow for a seasonal break. Global distribution improves responsiveness and resilience and strengthens relationships with sites and vendors – all of which help safeguard study timelines and data integrity.

Ensure coverage across the global holiday calendar  

Building and maintaining a global holiday calendar covering all trial regions, sites, labs, logistics partners, and regulatory authorities allows the CRO to model and anticipate staggered slowdowns in recruitment, data flow, and supply chains, and to adjust timelines and staffing accordingly. CROs maintain round the clock medical monitoring and case processing coverage to ensure adverse events (and serious adverse events) are reviewed and submitted per the required timeframes. Submissions are proactively scheduled outside holiday periods whenever possible. Such holiday calendars are integral for risk management, monitoring, and milestone plans. 

Robust on-call structures and role assignments, along with clear safety communication pathways and escalation procedures, are paramount at all times, even when certain personnel are unavailable. A pre-holiday safety review can help identify outstanding case follow-ups, reducing the risk of non-compliance during the holiday season. 

Ask about processes for proactive communication between sites, vendors, and sponsors 

Outreach is critical – confirming upcoming staffing levels, on-call coverage, and planned closures at least six weeks (ideally 10) before known holidays is a must. Outreach to labs, couriers, and vendors to identify reduced hours or busy periods helps navigate operational response. Close communication with the sponsor, ensuring they are well-informed, is also key.  

In addition, a global CRO with local presence will have specific knowledge of the site’s typical staffing levels and operational closures during holiday seasons. This gives the CRO extra information on which sites are likely to be best suited for selection for the duration of the trial, as well as the site’s flexibility to adjust activities accordingly (such as proactive arrangements for onsite monitoring visits) during festive periods.  

Check how the CRO will maintain focus on the patient 

CROs should work with sites to optimize patient visits around holiday windows – potentially adjusting these where allowed in the protocol. CRAs should help sites understand whether the protocol allows consolidated assessments, planning backup clinic days, or alternative facilities for sampling for time-sensitive endpoints.  

Telemedicine or remote visits are useful for maintaining continuity when patients are travelling or otherwise busy, and when sites are short-staffed. CROs also support sites with patient communication tools tailored to regional holidays to maintain engagement during extended holiday periods. 

Ask how the CRO will manage hurdles in the supply chain 

CROs coordinate early IP resupply, increase site safety stock, and pre-book shipments to avoid courier capacity issues. Alternative transport routes or backup couriers are also important to identify. Depots are consulted in the weeks leading to a holiday to ensure packaging, labeling, and release activities avoid closures. Real-time shipment tracking enables the CRO to monitor temperature- or time-sensitive materials.  

Prioritize CROs with well-defined data processes 

“Front-loading” monitoring activities before the holiday period (if the protocol and Monitoring Plan allow) and providing initial support for centralized or remote monitoring helps maintain data accuracy and integrity during holiday seasons. Critical datapoints (safety, dosing, primary endpoint data) should be prioritized. Monitoring cycles are planned in advance to cope with increased load after the holiday season.