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Friday, 18 March 2011 06:31
Partnerships In Clinical Trials Homes In On Change & Relationship Management In Uncertain Times
Revamped Program Features 100 Fresh Speakers, Advanced Networking and Time Management Tools, And Next Generation Partnership Guidance
Produced by The Institute for International Research (IIR USA) March 30 – April 1, 2011; Phoenix, AZ; Visit www.clinicaltrialpartnerships.com for information or to register.
IIR’s 20th annual Partnerships in Clinical Trials – the industry’s longest-running and most comprehensive event – has been revitalized and is primed to move at the pace of accelerating change.
The clinical trial research industry is now in flux:
Last year, we undertook an exhaustive research project to assess your needs and to identify your pain points in an era of uncertainty.
As a result, the 20th annual Partnerships in Clinical Trials has introduced an entirely new portfolio of innovative formats, tools and information services.
Your conference experience will be smarter and timelier, and it will be delivered with an unprecedented degree of precision:
– Market Insight Roundtable Discussions: a candid, interactive setting focused on mutual challenges – ongoing and emerging. Consolidate time-consuming, one-on-one networking conversations in one place, at one time. Space is limited!
The 2011 Partnerships in Clinical Trials program will not only raise the bar in clinical trials information and relationship-building services, but also shift it in line with changing times.
This may be the most important year to attend this event in two decades!
For more information or to register today, please visit www.clinicaltrialpartnerships.com.
Produced by The Institute for International Research (IIR USA) March 30 – April 1, 2011; Phoenix, AZ; Visit www.clinicaltrialpartnerships.com for information or to register.
IIR’s 20th annual Partnerships in Clinical Trials – the industry’s longest-running and most comprehensive event – has been revitalized and is primed to move at the pace of accelerating change.
The clinical trial research industry is now in flux:
- Sponsors are consolidating their outsource spend
- Specialty/niche pharma and biotechs are playing an increasingly prominent role
- Sponsors and providers are feeling the squeeze of rising regulatory scrutiny
Last year, we undertook an exhaustive research project to assess your needs and to identify your pain points in an era of uncertainty.
As a result, the 20th annual Partnerships in Clinical Trials has introduced an entirely new portfolio of innovative formats, tools and information services.
Your conference experience will be smarter and timelier, and it will be delivered with an unprecedented degree of precision:
- Highly focused learning opportunities segmented by specialization, and delivered in fresh, interactive environments
– Market Insight Roundtable Discussions: a candid, interactive setting focused on mutual challenges – ongoing and emerging. Consolidate time-consuming, one-on-one networking conversations in one place, at one time. Space is limited!
- Advanced networking, state-of-the-art connectivity and time management support
- Maximize and quickly customize your exhibition hall experience virtually
The 2011 Partnerships in Clinical Trials program will not only raise the bar in clinical trials information and relationship-building services, but also shift it in line with changing times.
This may be the most important year to attend this event in two decades!
For more information or to register today, please visit www.clinicaltrialpartnerships.com.
Published in
Clinical Trials Industry News
Wednesday, 09 March 2011 01:58
Partnerships In Clinical Trials Homes In On Change & Relationship Management In Uncertain Times
IIR’s 20th annual Partnerships in Clinical Trials – the industry’s longest-running and most comprehensive event – has been revitalized and is primed to move at the pace of accelerating change.
The clinical trial research industry is now in flux:
Last year, we undertook an exhaustive research project to assess your needs and to identify your pain points in an era of uncertainty.
As a result, the 20th annual Partnerships in Clinical Trials has introduced an entirely new portfolio of innovative formats, tools and information services.
Your conference experience will be smarter and timelier, and it will be delivered with an unprecedented degree of precision:
– Market Insight Roundtable Discussions: a candid, interactive setting focused on mutual challenges – ongoing and emerging. Consolidate time-consuming, one-on-one networking conversations in one place, at one time. Space is limited!
The 2011 Partnerships in Clinical Trials program will not only raise the bar in clinical trials information and relationship-building services, but also shift it in line with changing times.
This may be the most important year to attend this event in two decades!
For more information or to register today, please visit www.clinicaltrialpartnerships.com.
The clinical trial research industry is now in flux:
- Sponsors are consolidating their outsource spend
- Specialty/niche pharma and biotechs are playing an increasingly prominent role
- Sponsors and providers are feeling the squeeze of rising regulatory scrutiny
Last year, we undertook an exhaustive research project to assess your needs and to identify your pain points in an era of uncertainty.
As a result, the 20th annual Partnerships in Clinical Trials has introduced an entirely new portfolio of innovative formats, tools and information services.
Your conference experience will be smarter and timelier, and it will be delivered with an unprecedented degree of precision:
- Highly focused learning opportunities segmented by specialization, and delivered in fresh, interactive environments
– Market Insight Roundtable Discussions: a candid, interactive setting focused on mutual challenges – ongoing and emerging. Consolidate time-consuming, one-on-one networking conversations in one place, at one time. Space is limited!
- Advanced networking, state-of-the-art connectivity and time management support
- Maximize and quickly customize your exhibition hall experience virtually
The 2011 Partnerships in Clinical Trials program will not only raise the bar in clinical trials information and relationship-building services, but also shift it in line with changing times.
This may be the most important year to attend this event in two decades!
For more information or to register today, please visit www.clinicaltrialpartnerships.com.
Published in
Clinical Trials Industry News
Thursday, 24 February 2011 07:19
PRA Expands Operations in Europe and Middle East Continued Growth Prompts New Office Openings
PRA International, a leading Clinical Research Organization, announces the opening of new offices in Israel and the Ukraine to accommodate the firm’s continued global expansion and enhance our offerings for clients. This growth demonstrates PRA’s commitment to meet the increased demand for services in the Middle East and Eastern Europe.
PRA’s Israel office is conveniently located in Tel Aviv and will enhance local staff members’ availability to provide services in this area to our clients. PRA established an initial presence in Israel in 2007 through partnerships with local contractors. As demand increased, the company began hiring employees to advance operational capabilities there. Over the past several years, PRA has built a staff of 17 full‐time employees, including clinical research associates, clinical team managers and various other positions needed to conduct fullservice Phase II through IV clinical trials.
In the Ukraine, PRA has established an office in Kiev. Located in the business district of Podil, the facility is ideally situated to provide quality clinical research services in the country. PRA currently employs 15 staff members in the Ukraine, including 10 clinical research associates. With a population of nearly 50 million, the Ukraine has emerged as an attractive location for global studies.
“We are pleased to be able to provide an increased level of staffing through new offices in these two countries” said Dr. Ludger Langer, PRA’s Vice President of Clinical Operations in Europe, Asia‐Pacific and Africa. “These facilities bolster our offerings by providing centralized support for local teams to serve our clients in these regions.”
In addition to enhancing PRA’s abilities to manage a broad range of clinical trials across varying therapeutic indications, the new facilities further strengthen the company’s global presence.
About PRA
PRA conducts clinical trials across all therapeutic areas in more than 80 countries and provides services in all phases of clinical development through its 39 global offices.
PRA’s therapeutic expertise, global reach and project experience combined with its extensive local knowledge
and differentiating philosophy—THE PERSONAL ELEMENT— enable its project teams to deliver consistent and
on‐time performance. This unique PRA philosophy recognizes that true client service comes only from trained,
empowered and dedicated employees who are encouraged to be innovative and to use their personal
commitment to accelerate the development life cycle.
To learn more about PRA International, please visit www.
PRA’s Israel office is conveniently located in Tel Aviv and will enhance local staff members’ availability to provide services in this area to our clients. PRA established an initial presence in Israel in 2007 through partnerships with local contractors. As demand increased, the company began hiring employees to advance operational capabilities there. Over the past several years, PRA has built a staff of 17 full‐time employees, including clinical research associates, clinical team managers and various other positions needed to conduct fullservice Phase II through IV clinical trials.
In the Ukraine, PRA has established an office in Kiev. Located in the business district of Podil, the facility is ideally situated to provide quality clinical research services in the country. PRA currently employs 15 staff members in the Ukraine, including 10 clinical research associates. With a population of nearly 50 million, the Ukraine has emerged as an attractive location for global studies.
“We are pleased to be able to provide an increased level of staffing through new offices in these two countries” said Dr. Ludger Langer, PRA’s Vice President of Clinical Operations in Europe, Asia‐Pacific and Africa. “These facilities bolster our offerings by providing centralized support for local teams to serve our clients in these regions.”
In addition to enhancing PRA’s abilities to manage a broad range of clinical trials across varying therapeutic indications, the new facilities further strengthen the company’s global presence.
About PRA
PRA conducts clinical trials across all therapeutic areas in more than 80 countries and provides services in all phases of clinical development through its 39 global offices.
PRA’s therapeutic expertise, global reach and project experience combined with its extensive local knowledge
and differentiating philosophy—THE PERSONAL ELEMENT— enable its project teams to deliver consistent and
on‐time performance. This unique PRA philosophy recognizes that true client service comes only from trained,
empowered and dedicated employees who are encouraged to be innovative and to use their personal
commitment to accelerate the development life cycle.
To learn more about PRA International, please visit www.
Published in
Clinical Trials Industry News
Thursday, 24 February 2011 07:09
ERT Announces the Appointment of Eric Schwartz as Chief Legal Officer
ERT, a global technology-driven provider of clinical services and customizable medical devices to biopharmaceutical and healthcare organizations, announced today the appointment of Eric Ian Schwartz as Executive Vice President and Chief Legal Officer effective February 22, 2011.
Mr. Schwartz joins ERT with over 15 years of legal and executive management experience with high growth companies in the healthcare and technology industries. Most recently, Mr. Schwartz was Assistant General Counsel at Johnson & Johnson, where he served on the senior management teams of several of the fastest growing companies within Johnson & Johnson’s medical device and consumer products businesses. Previously, he was Vice President and General Counsel of Animas Corporation, a public medical devices company, manufacturing and distributing insulin delivery systems for people with diabetes. Animas was acquired by Johnson & Johnson in 2006. Mr. Schwartz also held several positions of increasing responsibility with Cable & Wireless Internet Services, Inc., and its predecessor, Digital Island, Inc. During his career, he has been responsible for a variety of legal, business development, and general management functions. Mr. Schwartz holds a B.A. and J.D. from the University of Virginia, as well as an MBA from the Wharton School of Business at the University of Pennsylvania.
Joel Morganroth, M.D., Chairman and Interim CEO commented: “We are all pleased that Eric will be joining the executive management team at ERT. In his position as Executive Vice President and Chief Legal Officer, he will be responsible for legal affairs, quality assurance, and regulatory compliance, contracts and proposals, and human resources for the Company. The increased complexity of ERT as a multi-service global company with plans to extend its products and services into adjacent markets makes the addition of a Chief Legal Officer particularly important in achieving the Company’s business plans.”
About eResearchTechnology, Inc.
ERT (www.ert.com) is a global technology-driven provider of clinical services and customizable medical devices to biopharmaceutical and healthcare organizations. It is the market leader for centralized cardiac safety and respiratory efficacy services in drug development and also collects, analyzes and distributes electronic Patient Reported Outcomes (ePRO) in multiple modalities across all phases of clinical research.
Mr. Schwartz joins ERT with over 15 years of legal and executive management experience with high growth companies in the healthcare and technology industries. Most recently, Mr. Schwartz was Assistant General Counsel at Johnson & Johnson, where he served on the senior management teams of several of the fastest growing companies within Johnson & Johnson’s medical device and consumer products businesses. Previously, he was Vice President and General Counsel of Animas Corporation, a public medical devices company, manufacturing and distributing insulin delivery systems for people with diabetes. Animas was acquired by Johnson & Johnson in 2006. Mr. Schwartz also held several positions of increasing responsibility with Cable & Wireless Internet Services, Inc., and its predecessor, Digital Island, Inc. During his career, he has been responsible for a variety of legal, business development, and general management functions. Mr. Schwartz holds a B.A. and J.D. from the University of Virginia, as well as an MBA from the Wharton School of Business at the University of Pennsylvania.
Joel Morganroth, M.D., Chairman and Interim CEO commented: “We are all pleased that Eric will be joining the executive management team at ERT. In his position as Executive Vice President and Chief Legal Officer, he will be responsible for legal affairs, quality assurance, and regulatory compliance, contracts and proposals, and human resources for the Company. The increased complexity of ERT as a multi-service global company with plans to extend its products and services into adjacent markets makes the addition of a Chief Legal Officer particularly important in achieving the Company’s business plans.”
About eResearchTechnology, Inc.
ERT (www.ert.com) is a global technology-driven provider of clinical services and customizable medical devices to biopharmaceutical and healthcare organizations. It is the market leader for centralized cardiac safety and respiratory efficacy services in drug development and also collects, analyzes and distributes electronic Patient Reported Outcomes (ePRO) in multiple modalities across all phases of clinical research.
Published in
Clinical Trials Industry News
Friday, 21 January 2011 06:35
eC-SSRS Solution from ERT Facilitates Compliance with New FDA Guidance
ERT, a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries, announced that its eC-SSRS (Electronic Columbia Suicide Severity Rating Scale) solution facilitates compliance with the newly introduced Food and Drug Administration (FDA) guidance document entitled “Suicidality: Prospective Assessment of Occurrence in Clinical Trials.” A copy of this guidance can be downloaded from www.ert.com.
The recently released FDA guidance document is intended to assist sponsors in assessing the occurrence of treatment-related suicidality in clinical trials or drug and biological products. The guidance highlights the increasingly recognized importance of suicidality assessment in psychiatric and non-psychiatric drug trials and provides general principles for how best to achieve effective assessment during the drug development process. The document highlights the Columbia Suicide Severity Rating Scale (C-SSRS), which comprises a detailed interview as an approved assessment instrument. The guidance intends to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the academic community and the public.
ERT’s eC-SSRS is an electronic self-rated version of the C-SSRS, which was developed in collaboration with the scale authors and provides a cost-effective method of proactively monitoring suicidality for trial sponsors. The solution was designed in anticipation of the FDA recommendations outlined in the newly released guidance document. Using interactive voice-response technology validated against the C-SSRS, the eC-SSRS is a fully structured interview providing standardized questions, relevant follow-up questions, error-handling routines and scoring conventions. Helping to facilitate the FDA requirements, the eC-SSRS solution enables timely identification of possible risks and supplies rapid feedback to study sites for evaluation and follow-up.
Michael Federico, Vice President, ePRO, comments, “The release of the FDA document highlights the growing focus on treatment-related suicidality and the need to develop an accurate and effective method for use in clinical trials to enhance effective patient-safety monitoring. Bearing in mind the concerns regarding the burdens placed on investigators, ERT has created the eC-SSRS, a validated representation of the interview version C-SSRS, which facilitates the ability to reliably and reproducibly assess suicidality and comply with FDA guidance.”
For further information on ERT and its technology and services, please email This email address is being protected from spambots. You need JavaScript enabled to view it. , call +1 215 972 0420 or visit www.ert.com.
For further press information, please contact Fiona Robinson, The Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom. Phone +44 1477 539539, Fax +44 1477 539540, email This email address is being protected from spambots. You need JavaScript enabled to view it. .
About ERT
Based in Philadelphia, PA, eResearchTechnology, Inc. (www.ert.com) is a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries. The Company is a market leader in providing centralized core-diagnostic electrocardiographic (ECG) technology and services to evaluate cardiac safety in clinical development. It is also a leading provider of centralized respiratory technology and services to evaluate pulmonary function efficacy and safety in clinical development. Sponsors can further use the Company’s solutions to streamline the clinical trials process by automating the collection, analysis, and distribution of ePRO clinical data using multi-mode technology in all phases of clinical development as well as selected medical devices for the clinical trials and healthcare industries.
The recently released FDA guidance document is intended to assist sponsors in assessing the occurrence of treatment-related suicidality in clinical trials or drug and biological products. The guidance highlights the increasingly recognized importance of suicidality assessment in psychiatric and non-psychiatric drug trials and provides general principles for how best to achieve effective assessment during the drug development process. The document highlights the Columbia Suicide Severity Rating Scale (C-SSRS), which comprises a detailed interview as an approved assessment instrument. The guidance intends to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the academic community and the public.
ERT’s eC-SSRS is an electronic self-rated version of the C-SSRS, which was developed in collaboration with the scale authors and provides a cost-effective method of proactively monitoring suicidality for trial sponsors. The solution was designed in anticipation of the FDA recommendations outlined in the newly released guidance document. Using interactive voice-response technology validated against the C-SSRS, the eC-SSRS is a fully structured interview providing standardized questions, relevant follow-up questions, error-handling routines and scoring conventions. Helping to facilitate the FDA requirements, the eC-SSRS solution enables timely identification of possible risks and supplies rapid feedback to study sites for evaluation and follow-up.
Michael Federico, Vice President, ePRO, comments, “The release of the FDA document highlights the growing focus on treatment-related suicidality and the need to develop an accurate and effective method for use in clinical trials to enhance effective patient-safety monitoring. Bearing in mind the concerns regarding the burdens placed on investigators, ERT has created the eC-SSRS, a validated representation of the interview version C-SSRS, which facilitates the ability to reliably and reproducibly assess suicidality and comply with FDA guidance.”
For further information on ERT and its technology and services, please email This email address is being protected from spambots. You need JavaScript enabled to view it. , call +1 215 972 0420 or visit www.ert.com.
For further press information, please contact Fiona Robinson, The Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom. Phone +44 1477 539539, Fax +44 1477 539540, email This email address is being protected from spambots. You need JavaScript enabled to view it. .
About ERT
Based in Philadelphia, PA, eResearchTechnology, Inc. (www.ert.com) is a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries. The Company is a market leader in providing centralized core-diagnostic electrocardiographic (ECG) technology and services to evaluate cardiac safety in clinical development. It is also a leading provider of centralized respiratory technology and services to evaluate pulmonary function efficacy and safety in clinical development. Sponsors can further use the Company’s solutions to streamline the clinical trials process by automating the collection, analysis, and distribution of ePRO clinical data using multi-mode technology in all phases of clinical development as well as selected medical devices for the clinical trials and healthcare industries.
Published in
Clinical Trials Industry News
Tuesday, 04 January 2011 11:13
Applied Clinical Intelligence, LLC Announces the Appointment of Vice President of Client Services
Applied Clinical Intelligence (ACI), LLC, announced today the appointment of Heather Mellon, MS to serve as Vice President, Client Services. In this role she will have responsibility for the sales and marketing efforts for the company.
Ms. Mellon comes to ACI with more than 15 years of experience, most recently serving as Executive Director, Business Operations at United BioSource Corporation, a medical and scientific affairs organization.
Ms. Mellon received her master’s degree in Applied Statistics from Villanova University and her bachelor’s degree in chemistry from Ursinus College.
She brings a strong track record in client management and operational leadership in clinical research organizations as well as extensive experience in data monitoring committee services.
“We are thrilled to have Heather join ACI”, said ACI President and CEO, Jonathon Seltzer, MD. “Her 15 years of pharmaceutical and clinical research experience will be an asset to ACI and our customers. Her skills in client, project, and financial management will assist ACI in reaching and serving more customers who will benefit from our services,” Seltzer said.
About ACI
ACI is a customer-focused contract research organization (CRO) serving the pharmaceutical, biotechnology, medical device and healthcare industries. ACI helps our customers achieve their goals by providing decision makers with the trusted information they need to clearly communicate the value and safety of medical treatments, drugs and devices, in a cost effective and business-focused manner. Our attention to customers is why ACI has among the highest rates of customer satisfaction and repeat business rate in the industry.
ACI: For more information, please visit www.a-ci.com.
Ms. Mellon comes to ACI with more than 15 years of experience, most recently serving as Executive Director, Business Operations at United BioSource Corporation, a medical and scientific affairs organization.
Ms. Mellon received her master’s degree in Applied Statistics from Villanova University and her bachelor’s degree in chemistry from Ursinus College.
She brings a strong track record in client management and operational leadership in clinical research organizations as well as extensive experience in data monitoring committee services.
“We are thrilled to have Heather join ACI”, said ACI President and CEO, Jonathon Seltzer, MD. “Her 15 years of pharmaceutical and clinical research experience will be an asset to ACI and our customers. Her skills in client, project, and financial management will assist ACI in reaching and serving more customers who will benefit from our services,” Seltzer said.
About ACI
ACI is a customer-focused contract research organization (CRO) serving the pharmaceutical, biotechnology, medical device and healthcare industries. ACI helps our customers achieve their goals by providing decision makers with the trusted information they need to clearly communicate the value and safety of medical treatments, drugs and devices, in a cost effective and business-focused manner. Our attention to customers is why ACI has among the highest rates of customer satisfaction and repeat business rate in the industry.
ACI: For more information, please visit www.a-ci.com.
Published in
Clinical Trials Industry News
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