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LATEST NEWS
New joint-venture between US and Panamanian investigators
06 January 2011
An innovative joint-venture between investigators working in Panama and their colleagues in the US has been launched, which aims to help Panamanian investigators establish clinical sites along the model pioneered by the Jacksonville Centre for Clinical Research (JCCR). The new Pan-American Medical ...
ICR collaborates with Cranfield University to launch training fellowships
10 September 2010
Cranfield University and the Institute of Clinical Research (ICR) are launching two funded research training fellowships for healthcare research professionals. The partnership, which currently runs an established MSc in Clinical Research, will extend this to award an MSc by Research and PhD ...
FDA issues draft investigator responsibility guidance
30 October 2009
US FDA has issued its draft guidance on investigator responsibilities with little change to the guidance issued in May 2007 apart from slight changes to the supervision of field engineers in device trials and sub-investigators. The goal of the guidance is to, "help investigators better meet their ...
Doctors want more information on trials
20 August 2009
Efforts by CROs to advertise their trials to physicians in the US are failing, according to a new survey by CenterWatch. Responses from 250 physicians across the US suggest that a lack of information about the drugs in trials prevented them from putting their patients forward. Director of market ...
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FEATURES
Strategies for dispute resolution with the FDA: a case study
25 August 2009
When disputes between sponsors and FDA reviewers cannot be resolved at the division level, a sponsor may appeal such disputes to higher levels within the FDA according to the agency's own guidance document on dispute resolution issued in February 2000. The dispute-resolution process may take months ...
What bothers clinical investigators?
25 August 2009
As the industry struggles with declining productivity as evidenced by the decreased number of submitted New Drug Applications (NDAs) and approved New Molecular Entities (NMEs), pharmaceutical management is examining every aspect of the R&D process to bring commercially attractive new drugs to ...
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PEOPLE
Biotec hires project managers to support growth
The clinical trials supply company Biotec Services International , has appointed two new project managers to strengthen the company’s expanding team. Clare Aubrey and Nicola Jenkins have been tasked with dealing with the increasing number of studies which are being undertaken by Biotec, which will ...
PharmaNet's Maida joins OncoSec board
OncoSec Medical , a therapeutic oncology company developing its advanced-stage ElectroOncology therapies to treat solid tumour cancers, has appointed Dr Anthony Maida to its board of directors and chair of its audit committee. Dr Maida was most recently vice-president of clinical research and ...
CRO veteran joins Waife & Associates
Waife & Associates , change management consultants in clinical research, has appointed Mark Di Ianni , of MDI Consulting Services , to head up its service provider management practice. Di Ianni has been a senior executive in the CRO industry for 30 years, founding and/or managing a series of ...
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COMMENTARY
Portfolio strategies for maximum effect
If your company is fortunate enough to have multiple projects in your development pipeline, and assuming that you do not have an unlimited resource pool, then you will be faced with some critical choices as to which projects to support and which projects not to support. Support of a project ...
ICH-GCP: older but perhaps not wiser
The ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1), to give it its full name, was adopted in Europe in 1996 (and in the US and Japan the following year). The aim of ICH-GCP is to provide a unified standard for the EU, the US and Japan to facilitate the mutual acceptance of ...
Breathing new life into the COPD market
Chronic obstructive pulmonary disease (COPD) is an umbrella term that refers to chronic lung diseases that share the common feature of restricted airflow. According to the most recent estimates from the WHO, there are currently 210 million COPD patients worldwide, of whom 80 million have moderate ...
Prevention is better than cure
Safety concerns are never far from view where pharmaceutical R&D is concerned. Early pre-clinical testing helps to determine whether a new substance is likely to cause serious adverse events in humans, and whether it should be progressed to clinical trials. While this has been the case for many ...
Excellence in site identification begins at home
We are all aware of a sponsor’s requirement to select investigators who are, as it states in the US Code of Federal Regulations, "qualified by training and experience as appropriate experts to investigate the drug" 1 in accordance with good clinical practices. However, the current competitive ...
Acne market fails to excite
Acne, the scourge of teenagers, is a chronic condition associated with blockage of the pilosebaceous ducts typically on the face, chest and back. The blockage is manifested as a comedo or ‘blackhead’ – the pigmentation is caused by melanin arising from the hair. In cases with more severe blockage ...
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