Successful Vendor Management in Clinical Trials

is being presented by Laurie Halloran, President and CEO, of Halloran Consulting Group, Inc. and airs on Wednesday, October 20th, 2010. For more details or to register, please visit our site at www.fxconferences.com

Effective management of outsourced clinical programs is a critical skill in companies that use external vendors to provide the required services for conducting clinical trials. But why does a sponsor need to monitor a CRO, and what are the best methods to ensure adequate oversight? What best practices should companies follow to ensure quality and consistency of outsourced operational work? This audio conference discusses the essential knowledge and skills required to identify, qualify, select, set and manage expectations of vendors throughout clinical projects of all sizes.

The Virtual CRO: Future of Drug Development Partnerships?

is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Thursday, September 30th, 2010. For more details or to register, please visit our site at www.fxconferences.com

The virtual contract research organization, or vCRO, is a relatively new concept in the world of drug development. It is a business model based entirely on strategic outsourcing, and companies that boast little or nothing in the way of brick-and-mortar facilities. As a result, these companies also have minimal overhead where staffing and facilities are concerned, and can pass those savings on to sponsors. In a world where drug development costs are skyrocketing, and at a time when working with traditional CROs has become a chronic pain point for many sponsors, there are those who predict this model will change the face of the industry.

But is the virtual CRO all it appears to be? Is it the right choice for all sponsors and all aspects of clinical research? What about laboratory testing or seeing patients at the site? This audio conference takes a critical look at the vCRO model, and discusses where and when it might be an appropriate option for sponsors, and conversely, situations where the traditional model might be a better choice.

Contracts: Aligning Sponsor & CRO Interests

A primary objective for the outsourcing and procurement divisions of pharmaceutical and biotech companies is to select the best CRO to undertake their project and deliver it to success. A primary objective for the CRO is to deliver the project to success and earn repeat business with the Sponsor. Both parties' core objective is the same: to deliver the study to success. However, for both organizations it is essential that the business objectives are aligned and therefore, when entering into a Sponsor-CRO contractual arrangement, there are various elements of risk to be considered by both parties.

This presentation, the last in a three-part series on best practices for outsourcing, focuses on the components of managing both legal and financial risk through effective contracting.

Contracts: Aligning Sponsor & CRO Interests was presented by Lynn Polgar, Associate Director, US Contract Management Group, with Covance and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs

Management of registries and other longitudinal studies creates unique challenges for sponsors, CROs, and other vendors. Programs of many years’ duration are faced with management and operational challenges. Management challenges include staff turnover at the sponsor as well as CROs and vendors. Proactive management of these staff changes that ensure successful ongoing team interactions is essential to program survival. Maintenance of project document history and documentation is another management challenge for long term programs. Ensuring that project decisions and documentation are well specified and accessible to all relevant stakeholders ensures common understanding and expectations across all stakeholder groups and assists project teams in addressing questions about decisions made by predecessor teams or team members.

Operational challenges for managing long term programs include changes in the marketplace and standards of care. Changes in these over time can significantly impact sponsor needs for data. Additionally data collection tools and strategies can also change significantly over time. Use of sequential adaptive methodology to anticipate potential changes at the program planning stage can facilitate changes as these are required over time.

Finally, challenges can be posed by turnover of site staff site, and long term involvement and enthusiasm of sites can be difficult to maintain. Strategies for successful engagement of sites for the study’s duration, and retraining of site staff over time require upfront planning and ongoing re-examination. Representatives from stakeholder groups including CROs, Other Vendors/Sponsors/Sites will discuss lessons learned from the management of long term programs including strategies that have contributed to successful management as well as pitfalls to avoid in managing future programs.

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs was presented by Eunice Franklin-Becker, Project Manager, Registries and Observational Studies, with Covance Periapproval Services and aired on 2009-02-25. For more details, or to download this conference please visit our site at www.fxconferences.com

Optimizing RFPs: Simple Steps to Better Responses

Is your organization in the process of putting together an RFP? Have the responses to your past RFPs fallen short of expectations? CRO teams respond to hundreds of RFPs each year. It is clear which sponsors have invested time to build internal consensus and to develop a document that clearly articulates their needs and project goals. The result is a guide that assists the CRO in assembling a higher quality response that directly addresses the needs of the sponsor.

This audio conference is the first in a three-part series designed to share best practices for optimal outsourcing.

Optimizing RFPs: Simple Steps to Better Responses was presented by Beth Mandel, Director of Strategic Solutions, with Covance, and is previously recorded. For more details or to download this audio conference, please visit our site at www.fxconferences.com

How to Select a CRO: Best Practices

The outsourcing and procurement divisions of pharmaceutical and biotech companies are charged with identifying and selecting external vendors most suited to assist them with delivering success for their organizations. Today, with the broad selection of companies available, offering a variety of services, a streamlined, straightforward selection process presents a challenge.

As a whole, the selection process represents a significant time investment from Sponsor organizations. One method for streamlining the selection process is to develop a set of standard criteria to evaluate and judge the respondents. However, the underlying complexity of the multiple variables involved raises questions as to the effectiveness of a standardized approach.

This audio conference is the second in a three-part series designed to share observations on best practices. This presentation discusses the components of CRO selection and will focus on comparing and contrasting a standardized approach versus customized approach.

How to Select a CRO: Best Practices was presented by Teresa Ptaszynska, BSc., PhD, Director, Proposal Development, with Covance and is previously recorded. For more details or to download this audio conference, please visit our site at www.fxconferences.com

International Sponsor-CRO Relationships: A Legal View

An ever-present issue for sponsor companies is whether to partner with a Clinical Research Organization. From that follows questions and strategies on how to best select a CRO and manage the relationship. The process takes on added dimension when conducting research internationally.

In this presentation, the speaker highlights key contract and relationship issues and the recurrent problems that arise within these relationships, and also offer practical, experience-based tips for maximizing the relationship's value and efficiencies. We discuss the difference between partner and vendor, and contract versus relationship. The presentation also examines local vs. U.S.-based CROs, and how to assess a CRO's experience and ability to comply with local rules and regulations and FDA requirements, as well as cooperating with the sponsor and other participating CROs.

International Sponsor-CRO Relationships: A Legal View was presented by Maria D. Buckley, of Nutter, McLennen & Fish, LLP. This audio conference is available for download at www.fxconferences.com

Optimizing RFPs: Simple Steps to Better Responses

Is your organization in the process of putting together an RFP? Have the responses to your past RFPs fallen short of expectations? CRO teams respond to hundreds of RFPs each year. It is clear which sponsors have invested time to build internal consensus and to develop a document that clearly articulates their needs and project goals. The result is a guide that assists the CRO in assembling a higher quality response that directly addresses the needs of the sponsor.

This audio conference is the first in a three-part series designed to share best practices for optimal outsourcing.

Optimizing RFPs: Simple Steps to Better Responses was presented by Beth Mandel, Director of Strategic Solutions, with Covance. It aired on 2006-12-06 and is available to download at our site www.fxconferences.com