While a shrinking world presents new clinical trial opportunities to sponsor companies, the challenges of conducting trials globally that are approvable by regulators can be daunting. Ever-changing country-specific requirements can slow down trials. Should these different requirements affect country selection for trials? Does a sponsor need an in-country partner to help? How can you manage vendors around the world? A panel of experts addressed these issues Tuesday afternoon.
Graciela Racaro of PAREXEL presented some critical success factors to carrying out global trials:
- Carrying out a feasibility study before country selection
- Developing a study start-up strategy that takes into account country-specific issues
- Learn local regulations and what the critical path is to getting a study approved in a country
- Developing patient recruitment and retention strategies
- Logistical concerns (time zones, language)
- Establishing expectations for monitoring quality
- Development of a risk plan and mitigations
- Plan ahead
- Appropriate and documented qualification assessment of vendors and CROs
- Use of Quality Agreements
- Build site and trial escalation processes upfront
- Conduct interim lessons learned meetings
- Coordinate for global inspection readiness
- Have an experienced trialist in each country and consider using a regional supervisor
The key takeaways from this discussion really centered on planning ahead, utilizing local resources and experienced partners and doing homework on country-specific regulations.
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