From Site to Sample: Considerations for Effective Minimal Risk Diagnostic Research

is being presented by Kathleen Mandziuk & Cathy Michael, Scientific Affairs Director & Senior Director of Comprehensive Solutions, with PRA & BioStorage Technologies and airs on Thursday, May 3rd, 2012. For more details or to register, please visit our site at www.fxconferences.com

*PRA is sponsoring this event, making it complimentary for all registered attendees. Please register for this event, and submit complete attendee information once you've registered, so we can assure you a space in the webinar. Incomplete registrations will not be honored. Please register each line for your group separately.*

Webinar highlights

The exponential increase of discovery, validation and commercialization of diagnostic and companion biomarkers has lead to a greater need for effective, efficient and proven research methods. Many industry experts focus on processing biological samples – however, what happens beforehand to ensure high-quality samples and data is collected?.

This educational webinar will focus on the evolving space of biomarker research and established techniques for cost-effective high-quality execution strategies. The speaker will cover a wide variety of topics from various industry perspectives.

Meeting the Challenges of Global Oncology Trials

Successful global oncology trials require careful planning, starting with looking at the strategic elements that span people, process and technology. Challenges in clinical research in oncology today include multiple new agents for multiple new targets combined with an increase in the number of patients needed to demonstrate that a therapy provides a significant benefit for patients. There is also a need to minimize the time it takes to go from basic science discoveries into clinical studies. The risk posed by delays in study start-up and patient recruitment can be mitigated by proactively planning for the study.

Planning needs to reflect the traditional and nontraditional considerations of feasibility and study design and incorporate trends and best practices. Patient recruitment is a key strategic consideration, along with epidemiological and genetic factors. Facilities, expertise and other resources along with technology play a key role in global trial planning.

Area-specific regulatory requirements vary in terms of standards of care, and differences among healthcare systems influence trial planning, as do local and cultural considerations.

This presentation will focus on the central challenges in global oncology trials today and make recommendations about how they might be addressed to mitigate risks in terms of timelines and costs.

This event is presented by Ute Berger of PRA International. To learn more, please visit www.fxconferences.com.

Optimizing Country Selection for Clinical Research

A number of elements can influence decision-making when developing a global footprint within the clinical research environment. These elements include: knowledge of the regulatory framework and timelines, suitability of the healthcare setting, compatibility of standard of care, interest within the physician community, internal resource availability to train sites and monitor high quality data, and the competitive landscape.

In this presentation, Dr. Stansfield will discuss these elements, with a primary focus on the ways that patient access can influence the successful outcome of clinical research for a new product. She will also highlight the pros and cons of different approaches.

The audio conference is presented by Susan Stansfield, PhD, Executive Vice President Product Registration Europe, Africa & Asia Pacific, of PRA International. For more details, please visit our site www.fxconferences.com

Leveraging Clinical Development Opportunities in India

India presents a compelling environment for global clinical trials because of its access to investigators, large patient populations with diseases of the industrialized and developing world, a cost-effective, English-speaking graduate workforce, and progressive regulatory environment. These benefits are now well recognized by the global pharmaceutical industry. Moreover, because of India's pristine FDA audits, continued streamlining of regulatory approvals and demonstrated intent to uphold international intellectual property standards, the country has become even more attractive as an important locale for clinical development.

As a result, multinational pharmaceutical companies are striving to build clinical development capabilities within their local operating companies in India, and the country's nascent CRO industry is enjoying an annual growth of about 40%. This, however, poses resourcing constraints and unresolved ethical issues about the robustness of patient consent. Hence, it is becoming increasingly important for sponsors to select investigators, sites and resources that will be able to deliver data of the quality and integrity that they seek. This presentation will draw on recent experiences and case studies related to the benefits and challenges of conducting clinical trials as well as data management in India.

This audio conference is presented by Nermeen Varawalla of PRA International. To learn more, please visit www.fxconferences.com.