One of the top major pharmaceutical companies approached Fisher Clinical Services for guidance on how to run an ambitious clinical trial in the Asia-Pacific region involving more than ten countries, 74 sites, and 400 shipments across the region.
This trial presented many challenges. It involved a cold chain investigational medicinal product (IMP) that needed to be kept at specified temperatures from point-of-origin to site delivery, a late-stage labelling of supplies to accommodate adaptive trial timelines, the need to access patient populations across many different countries in the Asia-Pacific region and in many remote locations, multiple latent changes in client requirements, and shortened timelines for fast drug approval.
It became apparent that this sponsor was going to totally rely on the Fisher Clinical Services team to manage this trial from start to finish.
Study planning and set-up
From the outset, it was clear that the sponsor was relying on Fisher Clinical Services to:
- Select the best courier companies across the region. To base this decision on its data driven objectivity and extensive statistics gathered on each distribution lane with multiple courier companies
- Understand the customs clearance challenges across all countries in the APAC region. To mitigate risk of delays by choosing courier companies that had a history of effective customs clearance over time
- Set up and perform late-stage labelling to meet changing requirements and timelines of the trial
- Suggest the best distribution plan to meet stipulated timelines and to get temperature-sensitive supplies to remote areas
- Give consultative advice on the possible risks and implications related to distribution into remote locations
Temperature control challenges
In certain periods of the year, South East Asia can experience extreme high temperatures of around 32°C. In addition, the Pacifica zone and South Korea have different temperature climates that can affect the shipping conditions of cold chain clinical supplies.
To help mitigate risk of temperature excursions on supplies during transit, the Fisher Clinical Services team:
- Carefully selected the most appropriate shipper box for the designated distribution channels, such as Summer versus Winter configuration, and specific technology-enabled shipper boxes during seasonal change
- Monitored and tracked shipments and gave guidance to appointed courier companies on how to maintain supplies within the correct temperature specification during transit
- Pro-actively communicated with customs officers so as to limit delays in customs clearance
- Distribution model including remote locations
Many of the target patient population lived away from the big cities, in newly developed satellite cities, or in more remote locations. Having thoroughly analysed the patient reach and expected delivery schedule for the entire study, the Fisher Clinical Services team identified that:
- Longer timelines would be required to reach the more remote areas of Thailand, Vietnam, Malaysia, Indonesia, and the Philippines. In many cases, an additional day was needed to reach sites located away from the main cities
- An established understanding was needed with the Sponsor / contract research organisation (CRO) prior to study kick off to allow a longer lead time for the intellectual property (IP) to reach the patient and to highlight in advance if a stressed timeline is required. Special arrangements were put in place in anticipation of urgent orders, such as sprinter services or dedicated truck services
- All import documentation and paperwork had to be completed in advance of shipments across the region. Advance notification of impending shipments to multiple parties involved (sponsor, importer, appointed clearance agent) would enable smooth customs clearance
- Close communication with all parties was paramount. A proactive attitude in responding to any requests for further information, such as ad-hoc documents needed by the customs officials that would help to mitigate delays and maintains product integrity during transit.
- Up-to-date information on customs requirements and regulatory changes was essential.
The success of this trial was measured in metrics, important for the sponsor when reviewing the trial and when planning new trials in the region:
- Performance reviews with courier companies helped achieve above satisfactory service during the trial
- Reduction in deviations and complaints through trending of incidences which then helped to prevent re-occurrence
- Overcoming cultural differences and language barriers ensured smooth distribution of supplies across the region
A 99% on-time delivery record to patients participating in this ambitious trial is a statistic to be proud of. However, we continue to work at achieving a 100% statistic. Let us never forget in our pursuit of performance perfection that at the heart of all we do is a patient.