A large, multinational pharmaceutical company wanted to engage a CRO capable of managing all ongoing or planned post-marketing surveillance (PMS) studies in Korea. The CRO would need to fulfil local regulatory requirements, which recently changed to allow sponsors more flexibility in the sample size of PMS studies, and to address the company’s specific requirements, such as an English-language study report and Basic Results for public disclosure.
The company was concerned about common challenges of conducting PMS
studies in many Asian countries, particularly in Korea, Japan, and China, where data collection and monitoring in the local language and familiarity with the local clinical system are necessary for success. While a local CRO could alleviate the specific language and cultural concerns, it was unlikely that they could also meet the global reporting requirements. The company feared that using an inexperienced CRO would lead to artificially high costs.

ICON proposed an “ICON plus local CRO” model, in which ICON provided operational services, including project management and monitoring, and back-end services for the English-language study report and Basic Results for public disclosure. A local CRO provided back-end services for a local regulatory report. This operational model satisfied the company’s needs cost-effectively.
The approach allowed centralised, programme-level oversight by ICON while leveraging extensive experiences of the local CRO for Korean PMS studies. The ICON project manager was the single point of contact for the client and had primary responsibility for overseeing study team members from ICON and the local CRO on every study. The ICON project director contributed to the streamlined programme-level oversight by closely communicating with the client’s programme lead.

The model offers flexibility to fit a variety of sponsor needs and operational demands, in Korea and other Asian countries, including:

•  expanding sub-contractual relationships to other local CROs with a presence in a
  specific country
• assessing data management vendors providing alternative electronic data
  capture platforms
• integration of services beyond fulfilling regulatory requirements, including:
  • medical writing for the publication of PMS data in scientific journals
  • dissemination of real-world evidence from PMS studies to
    healthcare professionals
  • medical expertise for protocol development or feasibility
    and optimisation

Because of this unique solution, the sponsor initially awarded ICON eight ongoing
and four planned studies. Due to the demonstrated effectiveness and efficiency of
the model, the sponsor chose to execute several additional PMS studies in Korea.
Nine studies were completed during the last four years, with all deliverables, costs
and timelines being met successfully.

Using an “ICON plus local CRO” model allowed the sponsor to conduct streamlined
and cost-effective post-marketing surveillance studies and achieve:

• mproved efficiency with application of the same SOPs and systems
  across studies
• Reduced training burden for the study team
• Continuous improvement initiatives based on accumulated knowledge
  and experiences
• Overall quality enhancement: An audit by the sponsor’s headquarters reported no
  quality findings for PMS studies.

Such efficiency would not have been expected if the studies had been outsourced
to several CROs.