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

Controlling Schedule II Narcotics: Operational Challenges in Conducting Clinical Trials

Many drugs that have safe and effective medical uses in clinical trials can also carry a potential risk for abuse. The United States Drug Enforcement Administration (DEA) has grouped these drugs into schedules, ranking them by their potential for abuse, from highest to lowest. This conference explores the steps necessary to comply with DEA and state regulations. It also focuses on the regulations surrounding use, distribution and control of Schedule II narcotics in a clinical trial, as well as the roles and responsibilities of the sites, monitors, managers and sponsors.

Controlling Schedule II Narcotics: Operational Challenges in Conducting Clinical Trials is being presented by Michelle D'Ovidio & Vanesa Castillo, Product Manager and Project Director, with Covance Periapproval Services and airs on Wednesday, June 3, 2009. For more details, or to register for this event, please visit our site at www.fxconferences.com

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies

Outsourcing in the life sciences industry is an established business practice that saves time and money. Medical device post-approval studies differ in both subtle and considerable ways from that of drugs or biologics, including how to approach and conduct mandated post-marketing studies. Successful partners in this realm require a firm understanding not only of the regulations, but also how to nurture seamless, high-functioning project teams.

This conference provides insights into building successful CRO partnerships that focus on medical device manufacturer needs, including risk analyses, communication plans, safety considerations (adjudications and DSMBs), effective team building and setting milestones and metrics to track success.

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies is being presented by Yvonne Albright and Barbara Vargas, Project Managers, with Covance Periapproval Services and airs on Thursday, April 16, 2009. For more details or to register, please visit our site at www.fxconferences.com

Preserving Relationships in the Face of Divergent Project Expectations

Managing divergent project expectations is a challenge that is often faced by project managers at CROs and sponsor companies. If a relationship becomes compromised, which strategies can address misunderstandings and improve relationships among shakeholders?

In this audio conference we discuss best practices for project planning to help ensure consistent expectations, and strategies for addressing divergent expectations and improving working relationships. We also talk about the importance of up-front planning to ensure consistent project expectations among stakeholders, and identify processes available to clearly define expectations and open channels of communication.

Preserving Relationships in the Face of Divergent Project Expectations is being presented by Michael Hill, Project Manager, Registries and Observational Studies, with Covance Periapproval Services and airs on Wednesday, April 8th, 2009. For more details or to register for this conference, please visit our site 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 is being presented by Eunice Franklin-Becker, Project Manager, Registries and Observational Studies, with Covance Periapproval Services and airs on Wednesday, February 25th, 2009. For more details or to register, please visit our site at www.fxconferences.com

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies

Outsourcing in the life sciences industry is an established business practice that saves time and money. Medical device post-approval studies differ in both subtle and considerable ways from that of drugs or biologics, including how to approach and conduct mandated post-marketing studies. Successful partners in this realm require a firm understanding not only of the regulations, but also how to nurture seamless, high-functioning project teams.

This conference will provide insights into building successful CRO partnerships that focus on medical device manufacturer needs, including risk analyses, communication plans, safety considerations (adjudications and DSMBs), effective team building and setting milestones and metrics to track success.

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies is being presented by Yvonne Albright and Barbara Vargas, Project Managers, with Covance Periapproval Services and airs on Wednesday, March 11th, 2009. For more details or to register for this conference, please visit our site 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 is being presented by Eunice Franklin-Becker, Project Manager, Registries and Observational Studies, with Covance Periapproval Services and airs on Thursday, February 25, 2008. For more information or to register for the conference, please visit our site www.fxconferences.com