Navigation Links
New Safety Regulations Drive Greater Need for Resources and Expertise at Every Stage of Clinical Development
Date:6/18/2009

to find better tools and novel approaches to implement the requirements of regulations efficiently and cost effectively," says Dr. Suzanne Gagnon, Chief Medical Officer, ICON Clinical Research.

The report was commissioned by ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, and developed by IMS Health, the world's leading provider of market intelligence to the pharmaceutical and healthcare industries.

Phase IV activities, including observational trials or "safety registries" that gather data on the use and effectiveness of medications in the real world are expected to be particularly impacted by new regulations, according to the survey. Eighty percent of respondents anticipate the number of Phase IV trials to grow over the next five years, while 58 percent indicated that safety registries increasingly will be used to monitor drug safety at every stage of the clinical trial process.

"The move toward greater transparency around drug safety remains a regulatory and political priority worldwide," says Nigel Burrows, Senior Principal, Management Consulting, IMS. "The pharmaceutical industry has and continues to respond to this challenge, both in drug clinical development and commercialisation. These efforts have the potential to go beyond simply satisfying regulatory requirements, leading to more clinically effective and commercially viable advances that improve outcomes and set new standards of care."

Notes to editors

Survey methodology

ICON commissioned IMS Health to conduct a survey that explored global trends in drug safety issues, and to evaluate the impact of recent safety regulations on the industry. A total of 140 people were questioned via a telephone interview, and included the heads of pharmacovigilance, safety and clinical research functions among pharmaceutical and biotechn
'/>"/>

SOURCE ICON plc
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily
2. AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA
3. Researchers Present Safety and Efficacy Results of 429 Patients Treated With Radiofrequency Ablation for Pre-Cancerous Barretts Esophagus
4. Living Donor Kidney Transplants Using Alemtuzumab Pre-Conditioning and Tacrolimus Monotherapy: Long-Term Safety and Efficacy
5. Results and Additional Analyses From Efficacy and Safety Study of Cortheras Relaxin in Acute Heart Failure to be Presented at Heart Failure Congress 2009
6. VIVUS Initiates Open Label Safety Study of Avanafil for Erectile Dysfunction
7. New Study Suggests Rx Estrogen Delivery Through the Skin May Show Safety Benefits as Opposed to Oral Delivery
8. Results From Study Show Promising Efficacy and Safety Results for Cortheras Relaxin in Acute Heart Failure
9. Clinical Data Reinforce Safety and Efficacy of Boston Scientifics Two Drug- Eluting Stent Platforms
10. RenalGuard(R) Pilot Safety Clinical Trial Data to be Presented at ACC 2009
11. Results From Efficacy and Safety Study of Cortheras Relaxin in Acute Heart Failure to be Presented at Late-Breaking Clinical Trials Session at ACC 58th Annual Scientific Session
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/4/2015)... N.J. and LOS ANGELES ... Diagnostics (NYSE: DGX ), the world,s leading ... it has completed the previously announced acquisition of ... As a result of the transaction, ... extensive range of innovative services and network of ...
(Date:8/4/2015)...  Sutro Biopharma today announced that it has ... president of alliance and project management. Dr. Vasquez ... of Sutro,s collaborative partnerships and the development of ... antibodies and antibody-based therapeutics targeting immuno-oncology pathways. ... of experience in the biopharmaceutical sector with expertise ...
(Date:8/4/2015)... Aug. 4, 2015  Delcath Systems, Inc. (NASDAQ: ... focused on oncology with an emphasis on the treatment ... abstracts summarizing data from studies in Europe ... Delcath Hepatic CHEMOSAT ® Delivery System (CHEMOSAT) will be ... annual congress, which will be held in ...
Breaking Medicine Technology:Quest Diagnostics Completes Acquisition of MemorialCare Health System's Laboratory Outreach Service Business in Southern California 2Sutro Biopharma Appoints Nicki Vasquez, Ph.D. as VP of Alliance and Project Management 2Delcath Announces Acceptance of Abstracts for Presentation at the European Association of Dermato Oncology Annual Congress 2Delcath Announces Acceptance of Abstracts for Presentation at the European Association of Dermato Oncology Annual Congress 3Delcath Announces Acceptance of Abstracts for Presentation at the European Association of Dermato Oncology Annual Congress 4
... III Clinical Trial of Acetavance(TM) for the Treatment of Fever ... ... of Omigard(TM) Completes Patient Enrollment, SAN DIEGO, May 6 ... focused on in-licensing,developing and commercializing proprietary product candidates principally,for use ...
... 5 Diplomat Specialty Pharmacy,announced today that their ... is now live and being utilized to manage,their ... eNAV(TM) as a,disease management tool for all disease ... Crohn,s Disease,and Chronic Kidney Disease., "Our current ...
Cached Medicine Technology:Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update 2Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update 3Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update 4Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update 5Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update 6Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update 7Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update 8Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update 9Diplomat Specialty Pharmacy Develops and Launches Best-In-Class Electronic Navigator (eNAV(TM)) Patient Care System 2
(Date:8/4/2015)... ... August 05, 2015 , ... Renowned review site BestMillionaireDatingSites.com recently refreshed its list ... has been ranked as the best dating service in the segment. , A representative ... It is essential that people find the right dating platform so that they can ...
(Date:8/4/2015)... ... August 05, 2015 , ... The National Association ... inductee into its VIP Woman of the Year Circle. She is recognized with ... organization exclusively for professional women, boasting more than 700,000 members and over 200 ...
(Date:8/4/2015)... ... ... NOVA Pride , Northern Virginia’s largest and newest LGBTQ nonprofit organization, ... join them in paving “The Road Ahead” at the second annual Northern Virginia Pride ... 2015, from 12-9pm. In order to ensure the success of this important event, NOVA ...
(Date:8/4/2015)... ... 2015 , ... How cool is it to check in at your favorite ... "Now" feature will soon allow you to do just that. , Ahhaa is releasing ... the now feature. , Users will soon get to share what inspires them about ...
(Date:8/4/2015)... , ... August 04, 2015 , ... Statement by Paul ... the introduction of the Mental Health Reform Act of 2015 by Senators ... mental health reform a reality in America. , “This legislation and H.R. ...
Breaking Medicine News(10 mins):Health News:BestMillionaireDatingSites.com Publishes Reviews of the Best Dating Sites for Wealthy Singles 2Health News:NAPW Inducts Deborah Stevens, Executive Assistant to Chairman and CEO at Mirion Technologies, Inc., Into its VIP Woman of the Year Circle 2Health News:NOVA Pride Announces Theme for the 2015 Northern Virginia Pride Festival 2Health News:NOVA Pride Announces Theme for the 2015 Northern Virginia Pride Festival 3Health News:NOVA Pride Announces Theme for the 2015 Northern Virginia Pride Festival 4Health News:Ahhaa App Soon to Release the "Now" Feature 2Health News:MHA Applauds Introduction of Mental Health Reform Act of 2015 2Health News:MHA Applauds Introduction of Mental Health Reform Act of 2015 3
... a device to monitor diabetics' blood sugar levels and ... on finger-prick blood tests and injections. ,The ... computer to monitor the patient's blood sugar levels and ... a media report. ,The key is the ...
... playing in the park; ,Age is grey,a toothless hag ... four lines reflect the glory of youth and the dismal ... romanticize youth, they shrink from the thought of greying hair, ... infirmities of old age. ,With the changing ...
... of anabolic steroids is linked to criminal activity such ... study published on Monday. // ,The ... of the muscle-building drugs however also revealed that steroid ... violent crimes such as murder, assault, rape and property ...
... Canadians are getting heavier , but a new study by Statistics Canada ... the same pace as they did earlier. //Adults between 18-64 were ... The data showed that they have put on weight steadily , but ... decreased. ,This welcome news is thought to be due to the ...
... have no one to look out for them. They are ... in the community without any money or family of their ... condition that impairs their judgment or ability to communicate. ... baby boomers age. ,There is only one state-funded program ...
... many parts of the world, the moral and legal aspects ... Various methods of inducing //abortions have been used throughout history ... crossed five in North America, who died from toxic shock ... people questioning the safety of the combination of the drugs ...
Cached Medicine News:Health News:Botox – The 'Celebrity' Dru 2Health News:Steroid Use Linked to Crimes 2Health News:Hoosiers Live at the Mercy of Nursing Homes 2Health News:Hoosiers Live at the Mercy of Nursing Homes 3Health News:Medically Induced Abortions (MIAs) Causes More Deaths Due To Infection 2
Tendril DX active-fixation leads allows for lower thresholds initially and during the lead maturation phase....
The Guidant Fineline II EZ Sterox with protective capsule is a steroid-eluting pacing lead designed for permanent implantation for either atrial or ventricular applications....
... Guidant Flextend lead is ... lead with an extendable/retractable ... helix design offers various ... permanent implantation in the ...
The CapSureFix line of pacing leads combines the benefits of steroid-eluting technology with screw-in active fixation, to allow long-lasting, low-threshold delivery of pacing therapies....
Medicine Products: