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LATEST NEWS
Partnering site publishes clinical site information
16 February 2010
Online drug development partnering site goBalto, has released over 16,000 clinical sites, physicians and hospitals so its members can find outsourced partnering providers. The database has added the sites from 175 countries to the list of over 10,000 service providers that goBalto has assembled and ...
Patient recruitment site launched...
New alliance helps share clinical site data...
Medpedia launches online trial matching tool for patients and doctors
15 February 2010
The Medpedia Project is to launch an online tool for patients and investigators searching for clinical trials that allow matching clinical trials to be 'pushed' to those searching in the appropriate context. According to industry statistics presented to the IOM Drug Forum in October 2009, between ...
Investigator pay findings could increase pressure on CROs
13 January 2010
Discrepancies between the actual reported compensation of clinical investigators and the amount budgeted for them by pharmaceutical companies could allow drug companies to strike harder bargains with CROs in the drive to lower outsourcing costs, according to a new report. The report, Clinical ...
PPD selected to train investigators in diabetes trials
21 December 2009
PPD has entered into an exclusive alliance with DiabetesAmerica™ to provide clinical research training and support to more than 20 clinical trial investigators who conduct diabetes clinical trials in DiabetesAmerica's 17 centres across Texas and Arizona. DiabetesAmerica will work exclusively with ...
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FEATURES
Fail-proof preparation for audit success
09 December 2009
An audit is a systematic and independent examination of trial-related activities and documents that determines whether these evaluated trial activities were conducted appropriately, and that the data were recorded, analysed and reported as specified in the protocol, the sponsor's Standard Operating ...
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 ...
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 ...
>> More Features...
PEOPLE
ACM appoints Asia Pacific manager
ACM Global Central Laboratory has appointed a new general manager of Asia Pacific, Nandan Rao , who will spearhead the company's growth in India and Southeast Asia. His first responsibility will be to oversee trials conducted by ACM's partner laboratory, before building the company’s own local ...
Venn Life Sciences hires new VP of business development
Venn Life Sciences has hired Dale Trask as vice-president of global business development. Mr Trask brings extensive experience in CRO business development and will be responsible for enhancing Venn's business partnerships, strategic relationships and growth into new markets. Mr Trask joins Venn ...
Entest Biomedical adds CRO experience to scientific board
Entest BioMedical has appointed Dr Vladimir Bogin to its scientific advisory board (SAB). Dr Bogin is the CEO of CRO Cromos Pharma. The company feels the addition of Dr Bogin to the SAB will "greatly assist in developing its clinical protocols as it moves forward to conducting both preclinical and ...
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COMMENTARY
Renal Failure: challenges and opportunities
The term renal failure describes a decline in the excretory function of the kidney due to a reduction in glomerular filtration rate. In adults, renal failure may be either acute, lasting from a few days to a few weeks, or chronic, lasting months to years. Acute renal failure is a medical ...
Filling the gaps
Most stakeholders in Europe are in favour of some form of EU centralised approval system for multinational clinical trials, with the pharmaceutical industry and the European Medicines Agency among the strongest backers for such a move. But the support is not unanimous: many national regulatory ...
The fight against malaria - all still to play for
If you didn't know, how many cases of malaria would you guess occur every year around the globe? A million? Two million? In fact, around 250 million cases of malaria occur each year. Most of these occur in developing countries, although malaria is also an issue for travellers from developed ...
UK wants harmonisation, not centralisation, of European trial approvals
The UK drug regulator, the MHRA, says it does not want a centralised approvals system for clinical trials in Europe, preferring instead the voluntary harmonisation project for authorising multinational studies that is currently being piloted in the EU. The MHRA also feels that introducing a single ...
EU promises multinational CTA harmonisation at last
The problem stems mainly from the way that the EU clinical trials Directive (2001/20/EC) has been implemented by the various member states. National authorities have different format, language and content requirements for clinical trial approvals, as well as different timelines for reviewing ...
Search continues for improved BPH treatments
The recent announcement by Boehringer Ingelheim that it plans to make the alpha blocker tamsulosin available without a prescription in the UK is a reflection of the continued interest in the benign prostatic hyperplasia (BPH) market. The condition affects some 15 million men across the seven major ...
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Designing the Future Conditions for Clinical Research in Europe
17 March 2010
Brussels, Belgium
ICR Annual Spring Conference and Exhibition
19 April 2010
London, UK
CDISC Interchange Europe
26 April 2010
London, UK
