Fisher Clinical Services’ client in Japan had a new compound for clinical development. They wanted to streamline clinical trial deployment, maximise efficiencies, and mitigate risk, with a view to accelerating time-to-market in this highly competitive environment.
Regulatory changes
Traditionally, only clinical trial data from Japan was accepted by the Pharmaceuticals and Medical Devices Agency (PMDA) for Japanese registration. This regulation has changed, and the PMDA now accepts clinical trial data from other Asian countries including Korea, Taiwan, and China. Fisher Clinical Services’ client made the decision to conduct its Phase II study in the wider Asia Pacific region.
Packaging efficiencies
The sponsor selected India as the country of choice for the packaging of its Phase II trial. Fisher Clinical Services Ahmedabad was the partner of choice for this sponsor due to its Free Trade Zone location and its compliance with Japanese good manufacturing practice (jGMP) standards, including 100% inspection.
Fisher Clinical Services, Ahmedabad, was identified as one of the only facilities in the Asia Pacific region fully audited and approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) for clinical trial packaging.
Once official approval was granted to the sponsor, the Fisher Clinical Services team was primed to initiate packaging immediately. In addition, smaller batch sizes were accommodated, whether automated or non-automated, allowing the sponsor to speed up delivery of clinical supplies to the target patient base.
Maintaining standards
It was important for the sponsor to ensure Japanese standards were being upheld in Ahmedabad. By using ‘Virtual Man-in-Plant’ technology, Fisher Clinical Services allowed the sponsor to view live packaging activities in Ahmedabad via a secure video link. This enabled the sponsor to ensure expected standards were being maintained at all times.
Tax savings
The Free Trade Zone in India is a duty free enclave and deemed to be a foreign territory for the purposes of trade operations, duties, and tariffs. Additional benefits it offered include:
- No license required for import / export
- No direct or indirect taxation (VAT, excise / customs duty, and import / export tax)
- No routine examination by customs officials of export or import cargo
Communication
The benefit of outsourcing to a global player was further evident to the sponsor as the project progressed. The sponsor was able to communicate with just one key contact person in Japan. The ability to work in the same time zone and the same language made it easy to conduct business with Fisher Clinical Services. This contact then managed all communication within the extended Fisher Clinical Services network.
Global sistribution via Singapore
The distribution of supplies was seamless to the sponsor. Fisher Clinical Services expertise in shipping large volumes of supplies globally, and choosing the best courier, lane, and route for all supplies allowed the sponsor to realise cost and performance efficiencies across the supply chain, delivering supplies on-time and in-full to the patient, while mitigating risk.
Fisher Clinical Services Ahmedabad worked with colleagues in Japan and Singapore to streamline distribution of supplies in small batch sizes. In addition, this primary contact person in Japan had the regulatory expertise that was needed to facilitate importation of supplies back into Japan and into Singapore.
New studies
This Japanese Sponsor is planning to follow this seamless, proven approach for future trials, packaging in India and distribution across the Fisher Clinical Services global network, supported by its local Fisher Clinical Services Japan team, removing language, cultural, and time zone barriers.