The alliance of regional specialists can provide the best of all worlds: global coverage, regional specialisation and mid-sized CRO flexibility.

A CRO partner must be able to deliver on the biotech’s specific needs and provide solutions to accelerate the drug development process.  Regional, specialist CROs have become a preferred partner for early phase studies. However, biotechnology companies are increasingly considering an alliance of regional specialists for large global trials.

In this case study, the biotech chose an alliance CRO model with one regional CRO taking lead for Asia Pacific and the US. All other services (including data management, investigational product and central lab management) were managed in-house but required coordination by the lead CRO.

The objective was to meet study milestones, and the study design was a randomised, open-label, multi-country study. It took place in Asia-Pacific (Australia, New Zealand, South Korea, Taiwan) and the US, across 15 sites and involving 90 patients.

Key challenges

  • Global trial in 3 different time zones – UK, US and Asia Pacific
  • Competition with oncology trials and staff
  • Restrictive inclusion/exclusion criteria
  • Complex study design with many assessments

Case study key findings

The lead CRO worked closely with their partner in the US to ensure that study start-up timelines were met. Key milestones included having their first patient’s visit four months from start-up, which was successful in both Australia and the US.

Each month’s progress was monitored and guided in group calls that were scheduled to suit time zones across the main regions.

Recruitment was difficult, but the CRO medical monitors’ interaction and meetings with Asia investigators eased recruitment considerably.

Strong alignment between the CROs and a deep understanding and adoption of a single set of methodologies delivered rapid results.

A teamwork culture was implemented for the dispersed global team (for example a series of international phone calls was better for the US vs emails followed by phone calls for Asia).

Database lock was one month after last patient/last visit.

Regional Vs Global CROs

A regional specialist CRO often has an in-depth understanding of local culture and knowledge of regulatory requirements, which facilitates optimal selection of sites, investigators, and fast, high-quality subject recruitment and retention.

Global CROs have wide geographic coverage. However, global CROs are commonly structured in a way that suits the requirements of big pharma, which may not meet the flexibility needs of biotechnology companies. In addition, biotechnology companies worry that their development programmes may not receive the attention they need when it comes to team selection and allocation to projects.

The misfit between biotechnology companies and global CROs often lead to regional mid-size CRO dealing with “rescue studies”.

Novotech: Accelerating clinical trials

Over the last 25 years, Novotech has partnered with numerous biotechnology companies and completed hundreds of projects. Novotech has consistently provided high-quality CRO services through a flexible approach that suits the needs of small and medium biotechnology companies.

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