is being presented by Dr Pete Harpum, Harpum Consulting and airs on Thursday, March 22nd, 2012. For more details or to register, please visit our site at www.fxconferences.com
The focus of work in the drug development industry is inexorably moving away from vertically integrated pharmaceutical and biotechnology companies – the ‘sponsors’ – to contract research organizations (CROs) and other third-party suppliers of services. Approximately 350,000 people have left employment in pharmaceutical and biotechnology companies – but they did not leave the industry. Many of these people moved from the sponsor/client side to the CRO/seller side. Drug development work is now increasingly done by third parties: the challenge facing industry is how to maintain and improve quality of service?
Partnering is a valuable strategy for clients and sellers to work together. In this presentation our speaker draws upon the lessons of other industries in which the majority of work is carried out by third parties in partnership with buyers, and looks at how partnering can facilitate high quality service provision by CROs.
Showing posts with label CROs. Show all posts
Showing posts with label CROs. Show all posts
Monday, March 19, 2012
Monday, January 9, 2012
An Overview of Recent Risk-based Monitoring Guidance from the FDA
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, January 25th, 2012. For more details, or to register please visit our site at www.fxconferences.com
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
Friday, May 27, 2011
Choosing and Managing Contract Medical Writers
is being presented by Dr. Susan Sisk, Principal, with SFP Consulting, LLC and airs on Thursday, July 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Contract writers, whether freelancers or CRO personnel, can be an important extension of medical writing resources during planned workload peaks or when unexpected writing projects arise.
This audio conference presentation is designed to provide sponsors with information on how to get the best product from a contract writer, and to show contractors how to ensure they produce materials that meet sponsors’ expectations.
Our speaker provides attendees with practical recommendations and case studies of successful collaborations, and emphasizes the process of report writing – including preparation of a shell report prior to availability of final data displays, and other activities that can maximize sponsor input and minimize the timeline after database lock.
Contract writers, whether freelancers or CRO personnel, can be an important extension of medical writing resources during planned workload peaks or when unexpected writing projects arise.
This audio conference presentation is designed to provide sponsors with information on how to get the best product from a contract writer, and to show contractors how to ensure they produce materials that meet sponsors’ expectations.
Our speaker provides attendees with practical recommendations and case studies of successful collaborations, and emphasizes the process of report writing – including preparation of a shell report prior to availability of final data displays, and other activities that can maximize sponsor input and minimize the timeline after database lock.
Tuesday, September 14, 2010
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.
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.
Wednesday, August 18, 2010
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.
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.
Thursday, August 12, 2010
Optimizing Resource Allocation and Capacity Planning
is being presented by Vladimir Shnaydman, President, of ORBee Consulting and airs on Wednesday, September 15th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Under constant pressure to reduce the cost of drug development, many biopharmaceutical companies and CROs are looking for ways to improve their capacity planning and resource allocation. It is critical for clinical organizations to find a better approach to increase effectiveness in resource capacity planning, especially for a portfolio of clinical trials. An optimal capacity planning solution includes proper resource utilization, allocation between ongoing and new trials, outsourcing strategy, hiring trend and budget allocation strategy for a variety of employee roles, and resource reallocation due to new or cancelled trials. It means identifying resource bottlenecks and optimal scheduling of new trials.
In this presentation, the speaker discusses a powerful decision-making methodology based on rigorous mathematical models for optimal capacity planning and resource allocation in clinical research, a technique which has been shown to reduce costs by up to 30% in some cases by uncovering better resource allocation solutions.
Under constant pressure to reduce the cost of drug development, many biopharmaceutical companies and CROs are looking for ways to improve their capacity planning and resource allocation. It is critical for clinical organizations to find a better approach to increase effectiveness in resource capacity planning, especially for a portfolio of clinical trials. An optimal capacity planning solution includes proper resource utilization, allocation between ongoing and new trials, outsourcing strategy, hiring trend and budget allocation strategy for a variety of employee roles, and resource reallocation due to new or cancelled trials. It means identifying resource bottlenecks and optimal scheduling of new trials.
In this presentation, the speaker discusses a powerful decision-making methodology based on rigorous mathematical models for optimal capacity planning and resource allocation in clinical research, a technique which has been shown to reduce costs by up to 30% in some cases by uncovering better resource allocation solutions.
Wednesday, June 30, 2010
SAFE-BioPharma – The Final Step to Fully Electronic Processes
is being presented by Kay Bross, Program Director, Member and Vendor Relations, with SAFE-BioPharma Association and airs on Wednesday, July 28th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Many large pharmaceutical companies are transitioning to the SAFE-BioPharma digital identity and digital signature standard. The standard was developed by a consortium of biopharmaceutical and related companies with participation from the US FDA and the European Medicines Agency, and is used to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents.
These sponsors are now asking CROs to obtain the necessary SAFE-BioPharma credentials to complete a fully electronic communication/transaction sharing circle. The payoff is faster exchanges and more readily accessible records, with accelerated turnaround for trial contract execution. Also, R&D eLab Notebook entries are secured into the future, and can be used as court evidence.
But how exactly do these digital identities and signatures differ from other electronic signatures, and what are the legal implications of using one over the other? In this audio conference, attendees get all the answers from Kay Bross of SAFE-BioPharma Association, the non-profit group that created and manages the SAFE-BioPharma® digital identity and digital signature standard.
Many large pharmaceutical companies are transitioning to the SAFE-BioPharma digital identity and digital signature standard. The standard was developed by a consortium of biopharmaceutical and related companies with participation from the US FDA and the European Medicines Agency, and is used to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents.
These sponsors are now asking CROs to obtain the necessary SAFE-BioPharma credentials to complete a fully electronic communication/transaction sharing circle. The payoff is faster exchanges and more readily accessible records, with accelerated turnaround for trial contract execution. Also, R&D eLab Notebook entries are secured into the future, and can be used as court evidence.
But how exactly do these digital identities and signatures differ from other electronic signatures, and what are the legal implications of using one over the other? In this audio conference, attendees get all the answers from Kay Bross of SAFE-BioPharma Association, the non-profit group that created and manages the SAFE-BioPharma® digital identity and digital signature standard.
Thursday, June 24, 2010
The Future of Clinical Trial Site and Patient Recruitment Is Here
is being presented by Kent Tholke, Senior Vice President, Scientific and Medical Affairs, with PRA International and airs on Thursday, July 22nd, 2010. For more details or to register, please visit our site at www.fxconferences.com
The key to successful site and patient recruitment is having the ability to mine electronic health records as well as pharmacy, claims, laboratory and historical CRO recruitment data using proprietary search algorithms. Current research indicates that more than 25% of clinical trial sites are unproductive. Relying on a data-driven decision making process will lead to far fewer non-productive clinical trial sites, shorter development timelines, greater patient recruitment and ultimately lower drug development costs.
With more clinical trials being conducted — and with the majority of them operating under delayed timelines — patient access has become the critical piece to solving what has become a very inefficient and costly puzzle known as drug development. While the process of drug development over the last few decades has been heavily driven by scientific methodology, the process by which clinical trials are conducted has consistently lacked the same rigor. Achieving successful patient access and meeting clinical trial timelines will require CROs to use more accurate processes for site selection and targeted patient enrollment.
Although having access to relevant data is important to enhancing site selection and patient recruitment, sponsors and CROs must also mine this data with algorithms that have been established to match planned patient populations and inclusion/exclusion criteria. When sponsors and CROs apply detailed search algorithms across multiple patient data platforms, they are able to find and target sites with the appropriate patient populations and confirm that the planned trial design matches customary care practices. This confirmation is the first step to both determining a trial’s feasibility and mining patient data. In addition, sponsor companies can use data-mining algorithms to determine if medical professionals are treating the target patient population as expected and to locate the patients by physician practice.
This audio conference explores the power of mining EHR/EMR, lab, pharmacy, claims and historical CRO recruitment data. It will also review how using data-driven decision making to validate trial designs and patient and site selection is a key to successful drug development.
The key to successful site and patient recruitment is having the ability to mine electronic health records as well as pharmacy, claims, laboratory and historical CRO recruitment data using proprietary search algorithms. Current research indicates that more than 25% of clinical trial sites are unproductive. Relying on a data-driven decision making process will lead to far fewer non-productive clinical trial sites, shorter development timelines, greater patient recruitment and ultimately lower drug development costs.
With more clinical trials being conducted — and with the majority of them operating under delayed timelines — patient access has become the critical piece to solving what has become a very inefficient and costly puzzle known as drug development. While the process of drug development over the last few decades has been heavily driven by scientific methodology, the process by which clinical trials are conducted has consistently lacked the same rigor. Achieving successful patient access and meeting clinical trial timelines will require CROs to use more accurate processes for site selection and targeted patient enrollment.
Although having access to relevant data is important to enhancing site selection and patient recruitment, sponsors and CROs must also mine this data with algorithms that have been established to match planned patient populations and inclusion/exclusion criteria. When sponsors and CROs apply detailed search algorithms across multiple patient data platforms, they are able to find and target sites with the appropriate patient populations and confirm that the planned trial design matches customary care practices. This confirmation is the first step to both determining a trial’s feasibility and mining patient data. In addition, sponsor companies can use data-mining algorithms to determine if medical professionals are treating the target patient population as expected and to locate the patients by physician practice.
This audio conference explores the power of mining EHR/EMR, lab, pharmacy, claims and historical CRO recruitment data. It will also review how using data-driven decision making to validate trial designs and patient and site selection is a key to successful drug development.
Friday, May 14, 2010
How to Avoid GCP Non-Compliance Issues in Your Clinical Trials
is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, June 22nd, 2010. For more details or to register please visit our site at www.fxconferences.com
Good Clinical Practice (GCP) is a set of ethical and operational principles which assure that the conduct of clinical trials and the data derived from those trials protect the participating human subjects and assure the quality, reliability and integrity of the clinical data. Because of the complexity of clinical trials, multiple personnel in the trial process have responsibilities for maintaining GCP compliance. However, in many instances, clinical trials are GCP non-compliant in at least one component of the study, at some point during the study. Depending on the non-compliant issues, GCP non-compliance can potentially lead to warning letters, suspension of the trial or rejection of some or all of the trial data by regulatory agencies.
In this audio conference, the speaker defines GCP, outlines the roles of those working on various aspects of the clinical trial (including sponsors, investigators, CROs, monitors and IRBs) and describes the documents necessary for performing a clinical trial. In addition, regulatory inspections and audits of clinical trials are discussed, along with common GCP non-compliance findings and resultant regulatory actions. Strategies and actions will be presented for maintaining GCP compliance.
Good Clinical Practice (GCP) is a set of ethical and operational principles which assure that the conduct of clinical trials and the data derived from those trials protect the participating human subjects and assure the quality, reliability and integrity of the clinical data. Because of the complexity of clinical trials, multiple personnel in the trial process have responsibilities for maintaining GCP compliance. However, in many instances, clinical trials are GCP non-compliant in at least one component of the study, at some point during the study. Depending on the non-compliant issues, GCP non-compliance can potentially lead to warning letters, suspension of the trial or rejection of some or all of the trial data by regulatory agencies.
In this audio conference, the speaker defines GCP, outlines the roles of those working on various aspects of the clinical trial (including sponsors, investigators, CROs, monitors and IRBs) and describes the documents necessary for performing a clinical trial. In addition, regulatory inspections and audits of clinical trials are discussed, along with common GCP non-compliance findings and resultant regulatory actions. Strategies and actions will be presented for maintaining GCP compliance.
Wednesday, May 5, 2010
Start-Up Strategies for Medical Device Trials
is being presented by Amy Wise, Clinical Research Manager, with PharmaNet Development Group and airs on Wednesday, June 16th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com
The start-up phase of any clinical trial is a hectic time, but there are several areas that require additional consideration and planning for medical device trials. The primary goals of the start-up phase are to distribute and collect documentation to approve each site for the initiation visit so enrollment can begin. However, additonal support and planning is needed by sponsors/CROs for device trials to assist sites with specific tasks such as medicare approval; device shipment, storage, and accountability; planning for maintenance of a blind; and documentation of staff training on the investigational device.
This audio conference discusses how proactive planning and timely responsiveness to site requests can help make the start-up phase for medical device studies more efficient, and can lay the foundation for a positive relationship with the sites that will continue through the life of the study.
The start-up phase of any clinical trial is a hectic time, but there are several areas that require additional consideration and planning for medical device trials. The primary goals of the start-up phase are to distribute and collect documentation to approve each site for the initiation visit so enrollment can begin. However, additonal support and planning is needed by sponsors/CROs for device trials to assist sites with specific tasks such as medicare approval; device shipment, storage, and accountability; planning for maintenance of a blind; and documentation of staff training on the investigational device.
This audio conference discusses how proactive planning and timely responsiveness to site requests can help make the start-up phase for medical device studies more efficient, and can lay the foundation for a positive relationship with the sites that will continue through the life of the study.
Thursday, March 11, 2010
Optimizing Regulatory Compliance Throughout the Drug Development Process
is being presented by Dr. Ruth Ann Lee, Director and Executive Consultant, Scientific Consulting, with Beckloff Associates, Inc. and airs on Tuesday, April 20, 2010. For more details or to register, please visit our site at www.fxconferences.com
Compliance is not passive! The regulatory agencies expect you to continuously evaluate and monitor your state of compliance, maintain compliance, and ensure sustained compliance. By understanding the interplay of regulations as the drug substance and drug product transition from lead compound through final commercialization, a drug development program can be optimized to prevent delays that can result in lost time, delayed return on investment and a shorter market life cycle.
This audio conference provides an overview of the regulatory compliance requirements through the various phases of product development. The speaker discusses the take-away message from current FDA compliance activities and present options to prevent, respond, and remediate compliance issues as necessary.
Compliance is not passive! The regulatory agencies expect you to continuously evaluate and monitor your state of compliance, maintain compliance, and ensure sustained compliance. By understanding the interplay of regulations as the drug substance and drug product transition from lead compound through final commercialization, a drug development program can be optimized to prevent delays that can result in lost time, delayed return on investment and a shorter market life cycle.
This audio conference provides an overview of the regulatory compliance requirements through the various phases of product development. The speaker discusses the take-away message from current FDA compliance activities and present options to prevent, respond, and remediate compliance issues as necessary.
Wednesday, January 13, 2010
Finding and Assessing Global Drug Development Partners
It takes, on average, somewhere around 15 years and a billion dollars to take a drug development project “from bench to bedside.” One factor contributing greatly to that protracted timeline is the significant difficulty in finding and then collaborating with qualified partners. The problem is exacerbated when development is taking place on a global scale. Asking colleagues and consultants might net you a recommendation for the largest CROs, but if you need a good regulatory consultant familiar with Chinese Investigator Document Review, for example, you could be out of luck. And even when a pharma company does identify a service provider, the interaction isn't straightforward: there is no simple way of searching for and comparing services, profiles and reputation.
There are myriad websites designed to help consumers find hotels and local businesses, and they have made these transactions much more transparent. However, the life sciences industry has lagged behind: companies still mainly generate leads on development partners largely by word of mouth and by attending industry trade shows and conferences. In this audio conference, our speaker explores new ways to connect, evaluate and engage drug development partners around the world.
Finding and Assessing Global Drug Development Partners is being presented by Jae Chung, Founder & CEO, of goBalto and airs on Tuesday, February 9, 2010. For more details or to register, please visit our site at www.fxconferences.com
There are myriad websites designed to help consumers find hotels and local businesses, and they have made these transactions much more transparent. However, the life sciences industry has lagged behind: companies still mainly generate leads on development partners largely by word of mouth and by attending industry trade shows and conferences. In this audio conference, our speaker explores new ways to connect, evaluate and engage drug development partners around the world.
Finding and Assessing Global Drug Development Partners is being presented by Jae Chung, Founder & CEO, of goBalto and airs on Tuesday, February 9, 2010. For more details or to register, please visit our site at www.fxconferences.com
Monday, December 7, 2009
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
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
Friday, December 4, 2009
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 draws on recent experiences and case studies related to the benefits and challenges of conducting clinical trials as well as data management in India.
Leveraging Clinical Development Opportunities in India was presented by Dr. Nermeen Varawalla, Vice President, Investigator Relations, with PRA International and aired on 2007-05-30. For more details or to download this event, please visit our site at www.fxconferences.com
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 draws on recent experiences and case studies related to the benefits and challenges of conducting clinical trials as well as data management in India.
Leveraging Clinical Development Opportunities in India was presented by Dr. Nermeen Varawalla, Vice President, Investigator Relations, with PRA International and aired on 2007-05-30. For more details or to download this event, please visit our site at www.fxconferences.com
Thursday, December 3, 2009
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
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
Thursday, November 19, 2009
Clinical Investigations in Asia
Managing clinical studies in Asia can be both rewarding and challenging, as researchers face such issues as language, regulatory requirements and logistics. However, delays and frustrations can also arise if local practices -- such as standard treatments, insurance and reimbursement, indemnification of sites and investigators, and administration of study grants -- are not considered and anticipated. In addition to a well-structured feasibility study which provides meaningful information and data, the unique considerations of "locality" and corresponding solutions would be of value.
Whether or not a sponsor engages a CRO for Asian studies, it is important that they thoroughly understand the differences, the uniqueness (what and why things are done the way they are in Asia), and the latest on the local regulatory fronts, in order to assemble a solid and achievable clinical management plan.
Focused on China, Taiwan, Hong Kong, South Korea, Japan, Thailand and Singapore, this presentation draws on the benefits and challenges of managing clinical trials in Asia, based on recent experiences. The speaker also addresses critical points to ensure successful project start-up and conduct.
Clinical Investigations in Asia was presented by Edward C. Ian, Director of Operations in Asia, with PRA International and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com
ForeignExchange Translations provides specialized Korean, Japanese, and Chinese translation services to medical device and pharmaceutical companies.
Whether or not a sponsor engages a CRO for Asian studies, it is important that they thoroughly understand the differences, the uniqueness (what and why things are done the way they are in Asia), and the latest on the local regulatory fronts, in order to assemble a solid and achievable clinical management plan.
Focused on China, Taiwan, Hong Kong, South Korea, Japan, Thailand and Singapore, this presentation draws on the benefits and challenges of managing clinical trials in Asia, based on recent experiences. The speaker also addresses critical points to ensure successful project start-up and conduct.
Clinical Investigations in Asia was presented by Edward C. Ian, Director of Operations in Asia, with PRA International and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com
ForeignExchange Translations provides specialized Korean, Japanese, and Chinese translation services to medical device and pharmaceutical companies.
Tuesday, September 15, 2009
Outsourced Data Management: How to Align Performance Expectations
When it comes to clinical development outsourcing, it is not uncommon to see that data management has not been included in the process until it is well underway or nearly complete. Unfortunately, this tactical approach to data management outsourcing opens the door for performance expectations to diverge once the trial is underway, as initial expectations were never made transparent and fully aligned.
This session explores the challenges and strategies involved in successful data management outsourcing between sponsor companies and CROs. The speaker shares his insights and offers actionable, pragmatic approaches to consider, and reviews case studies which measure the impact of these approaches on a sponsor’s business success.
Outsourced Data Management: How to Align Performance Expectations is being presented by Mark Anderson, Senior Director, Clinical Data Management, with Covance and airs on Wednesday, October 28, 2009. For more details or to register, please visit our site at www.fxconferences.com
This session explores the challenges and strategies involved in successful data management outsourcing between sponsor companies and CROs. The speaker shares his insights and offers actionable, pragmatic approaches to consider, and reviews case studies which measure the impact of these approaches on a sponsor’s business success.
Outsourced Data Management: How to Align Performance Expectations is being presented by Mark Anderson, Senior Director, Clinical Data Management, with Covance and airs on Wednesday, October 28, 2009. For more details or to register, please visit our site at www.fxconferences.com
Monday, July 13, 2009
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
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
Thursday, July 9, 2009
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
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
Tuesday, June 16, 2009
Improving Patient Recruitment Through Better CRA Training
The clinical trial industry's single greatest challenge continues to be timely patient recruitment and retention. One major obstacle is trial drift -- the gradual reduction in study knowledge as a clinical trial ages, resulting largely from inadequate staff training about the protocol and good clinical practices (GCP). The problem is further compounded by high turnover among site staff, with industry data suggesting an average CRA tenure of only 18 months to 2 years -- shorter than many studies.
At the same time, regulatory agencies are increasingly demanding proof that global clinical study staff are appropriately trained and assessed in a standardized manner and, depending on the therapeutic area, that ongoing "recalibrations" in staff education and training are performed during the term of a study in order to minimize trial drift. What's more, there is a growing movement in the industry to require site managers and CRAs to earn GCP certification, further underscoring why effective training is a business imperative.
This presentation focuses on how a well-planned, consistent training program can help sponsors and CROs meet or even exceed enrollment deadlines, and thereby speed drug development.
Improving Patient Recruitment Through Better CRA Training was presented by Linda Wolf, with BBK Worldwide Alliance and aired on 2008-05-22. For more details, or to download this conference please visit our site at www.fxconferences.com
At the same time, regulatory agencies are increasingly demanding proof that global clinical study staff are appropriately trained and assessed in a standardized manner and, depending on the therapeutic area, that ongoing "recalibrations" in staff education and training are performed during the term of a study in order to minimize trial drift. What's more, there is a growing movement in the industry to require site managers and CRAs to earn GCP certification, further underscoring why effective training is a business imperative.
This presentation focuses on how a well-planned, consistent training program can help sponsors and CROs meet or even exceed enrollment deadlines, and thereby speed drug development.
Improving Patient Recruitment Through Better CRA Training was presented by Linda Wolf, with BBK Worldwide Alliance and aired on 2008-05-22. For more details, or to download this conference please visit our site at www.fxconferences.com
Subscribe to:
Posts (Atom)