Email ID
Password
Forgotten your password?
Advanced Search
Home
Companies
Patients
Investigators
Trials & Research
Regulatory
Therapeutics
Regulatory
LATEST NEWS
FDA issues draft guidance on adaptive trial protocols
10 March 2010
The US FDA has issued draft guidance on adaptive trial designs which encourages sponsors to have early meetings with agencies. The guidance "discusses clinical, statistical, and regulatory aspects of a wide range of adaptive design clinical studies that can be proposed as part of a drug development ...
ICR suggests Clinical Trials Directive be revised...
FDA chief moves to limit secrecy...
Sponsors must report falsified data within 45 days under FDA proposed rule
26 February 2010
The US FDA has proposed a new rule that would make trial sponsors report any falsified trial data to the FDA within 45 days. The FDA is hoping that the information collated from sponsors will inform any pattern indication and help to identify signals of misconduct to form the basis of increased ...
FDA emphasises postmarketing safety in 2011 budget outline
04 February 2010
The FDA is asking for an extra $28million in its 2011 budget request to enhance its postmarketing safety activities, with the Sentinel Initiative to benefit as well as the CDER's centre and field activities. The budget request, which comes under the Protecting Patients Initiative, "will support the ...
CDISC appoints new chairperson
20 January 2010
A Quintiles executive will become the next chair of the board of directors of the Clinical Data Interchange Standards Consortium (CDISC), helping to shape the direction of a body which seeks to streamline standards and reduce complexity in biomedical research. Paula Brown Stafford , executive vp ...
>> More Latest News...
FEATURES
Strategies for periodic safety reporting: update on the new DSUR concept
04 February 2010
The submission of periodic reports to Regulatory Authorities (and ethics committees) is mandatory in many countries. In the USA for instance, an Investigational New Drug (IND) Annual Report detailing the safety profile of an investigational drug is submitted to the FDA on an annual basis. ...
Reviving the Japanese clinical trial system
21 January 2010
Japan is one of a few countries that develop innovative medicine for patients globally and as in other countries, such as America and China, Japan has some unique regulatory requirements for conducting its clinical trials. In 1996 the ICH-GCP standards were agreed across Japan, the US and the EU, ...
EndPoint: Janette Benaddi
21 January 2010
Janette Benaddi, chair of the Institute of Clinical Research Janette Benaddi has over 20 years experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Prior to founding Medvance 12 years ago, she worked in Paris for a medical device consultancy group as a ...
GPP versus GCP: design, conduct, implementation and interpretation of observational studies
30 November 2009
Observationalstudies involve the examination and evaluation of "medical care without 'controlling' the therapy beyond normal medical practice," and in general, GCPs were mainly designed for experimental studies to ensure a controlled framework in which investigational product is given to a subject ...
>> 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 ...
>> More People...
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 ...
>> More Commentary...
About Us
Getting Started
Subscribe
FREE Trial
Advertise
Awards
White Papers
EVENTS
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
