As the industry struggles to control R&D costs and accelerate innovation in the near term part of the fix is to grow market share in emerging markets. This necessitates conducting clinical trials all over the world. While the number of trials outside the US grows, trial sponsors are relying more heavily on CRO partners for site recruitment, site evaluation and set-up. So in effect, the distance between the trial sponsor and the investigational site is not just growing in miles, but in people layers as well. How can this distance be overcome and quality guaranteed?
At IIR’s 3rd Annual Partnerships in Clinical Trials Latin America event August 13-15, 2012 in Sao Paulo, Brazil, this topic along with many others will be addressed. Specifically the workshop “Best Practices in Clinical Research Management: Setting Up and Running a Successful Clinical Research Site in Latin America” lead by Juan Luis Yvarren, Research Director at Centro De Investigacion Recardo Palma (Peru) and Dr. Pedro Garbes-Netto, Regional Director, Clinical Development, Latin America from Sanofi Pasteur geared specifically for Clinical Sites in the region will tell you how to:
- • Structure organization and partnerships with quality management processes
- • Implement design elements to prevent and minimize errors
- • Define tools for project management that improve decision making
- • Train and retain staff in your clinical research site
- • Improve study budget and negotiation strategies with CROs and trial sponsors
Dr. Motti made another very interesting point, protocol design is frequently done without investigator input and once a site receives the protocol it is already finalized. An important step, once taken for granted in clinical development process, now often skipped. Is this going on at your organization? How can it be changed? Should it be changed? Where do you stand?
To learn more about who is attending and the incredible speakers at the 3rd Annual Partnerships in Clinical Trials event visit the website. As a reader of this blog, when you register to join us and mention code XP1718BLOG, you'll receive $100 off the current rate!
This post was authored by Managing Director, Pharmaceutical Division, IIRUSA, Megan Antonelli.