Breaking News on Contract Research, Manufacturing & Clinical Trials

Hot Topics > Clinical evolution

Clinical evolution

Randomised clinical trials have been the mainstay of pharmaceutical product development for decades, but will they be designed and carried out the same way in future? With trials tipped to get smaller and patient selection more complex as pharma’s blockbuster model is dismantled, interactive technologies, adaptive designs and new ways to recruit and monitor patients will come to the fore.

EFPIA and PhRMA Accused of Mobilising Patients Against EU Trial Transparency Plans

23-Jul-2013 - The EFPIA and PhRMA are targeting an "army" of patient groups to lobby EU plans to publish clinical trial data, according to a leaked memo.

Wuxi Buys Instem’s Remote Study Monitoring Tool

23-Jul-2013 - China’s top CRO Wuxi Apptec has purchased a remote clinical trial monitoring tool that will allow its toxicology clients log onto a secure Web site to view data from on-going studies....

Update

AstraZeneca Partners with CRO-Like Institute to Develop Personalized Oncology Compounds

08-Jul-2013 - AstraZeneca has selected the Sarah Cannon Research Institute (SCRI) to help develop oncology compounds using molecular profiling to more accurately predict a patient's response.

Trial Site Feasibility Platform Looks to End Onerous Paper Questionnaires

03-Jul-2013 - The antiquated process of evaluating clinical trial sites through paper questionnaires may be coming to an end thanks to a new online platform.

Dispatches from DIA

CROs, Sponsors Yet to Cement Appropriate Risk-Sharing Models, Execs Say

01-Jul-2013 - Sponsors are piling on more responsibilities for their CRO partners, but the question of how that will translate into increases in risk and profit sharing is a point of contention.

DISPATCHES FROM GPCM

BIg Pharma's Shift from R&D Opportunity for CDMOs, Says Expert

26-Jun-2013 - With small companies and biotechs increasingly discovering new products, there are big opportunities for contract development and manufacturing organisations (CDMO), says ex-GSK expert.

Online Adverse Event Monitoring Could Guide Ph IV Spending say Researchers

24-Jun-2013 - Researchers behind a new automated adverse drug event monitoring method say it could act as an early warning system and guide Phase IV trials. 

Clinical Cymru Can Compete on Costs says PRA

15-May-2013 - PRA International says technology and IT innovation will help it compete with rivals that have moved their service centres to cheaper locations in the East to cut costs.

Eisai Appoints New Trials Exec To Help Stop Late-Stage Failures

16-Apr-2013 - Eisai has tasked a new exec with making trials more likely to succeed just a few months after its candidate ovarian cancer blockbuster failed at Phase III.

Particle Science, Agility, Cliantha: CRO Collaborations

06-Mar-2013 - Welcome to Outsourcing-Pharma.com’s round-up of CRO focused partnerships and collaborations including news from Particle Science and Agility Clinical Partners.

M&A motivations differ for CROs and PE investors but deals will continue, says broker

06-Feb-2013 - CROs invest in scope and scale while private-equity groups buy firms they can expand according to Fairmount Partners’ managing director, Neal McCarthy.

update

Trials published by Pfizer didn't match internal docs say researchers calling for CONSORT revision

05-Feb-2013 - Clinical trials made public by Pfizer did not match internal reports or reflect what was done in studies of the seizure drug gabapentin say researchers calling for revision of journal...

JLL bids $123m for Bioclinica and plans imaging bolt-on

31-Jan-2013 - Bioclinica has agreed to a takeover by JLL Partners in a deal that would see the eClinical provider merge with medical imaging firm CoreLab Partners.

FDA Adopts 'Practical' ICH Q&A to Clarify Clinical Study Reports

30-Jan-2013 - The US Food and Drug Administration (FDA) has adopted a practical Q&A  from the International Conference on Harmonisation (ICH) to help sponsors and CROs craft clinical study reports (CSRs), an expert...

Variations in site recruitment performance a risk, says Tufts

16-Jan-2013 - Variation in site recruitment performance is a major risk factor for CROs and their sponsors according to new research.

New Guideline Lays Out Minimum Content of a Clinical Trial Protocol

15-Jan-2013 - Experts have created a new minimum content guideline addressing quality gaps seen in many trial protocols.

News in brief

Icon teams with EHR speclalist Cerner

10-Jan-2013 - Icon claims its collaboration with electronic Health record (EHR) specialist Cerner will help drug and device makers streamline data collection.

Parexel buys Liquent for $72m

03-Jan-2013 - Parexel has acquired niche regulatory information management software firm Liquent and raised its guidance for 2013.

Pfizer could re-launch virtual trial programme as soon as 2013

27-Nov-2012 - Pfizer is re-jigging its failed virtual trial model and could re-launch the programme as soon as 2013.

News from CPhI

India will stamp out "fly by night operators" in trial industry, says Gov

27-Nov-2012 - The Indian Government will stamp out “fly by night operators” in its clinical trials sector by plugging "loopholes" in the regulations.

Risk-based monitoring could simplify trial data QC, according to Annex Clinical

26-Nov-2012 - Risk-based monitoring means certain aspects of clinical trials can be quality checked using a segment of the data, according to Annex Clinical.

News from PCT

CRA turnover in China too high: PCT discussion

21-Nov-2012 - High CRA turnover in China often hinders trials, according to an Oxford University expert.

News in brief

Boehringer set to make E.coli for clinical trials

12-Nov-2012 - Molecular Partners has contracted Boehringer Ingelheim to produce a range of highly potent molecules for its clinical pipeline.

Report from PCT Europe

Is risk-based clinical trial monitoring too flexible for the regulators?

12-Nov-2012 - Risk-based monitoring for clinical trials was a hot topic at this year’s PCT Europe thanks to recent draft guidances from the FDA and the EMA.

DISPATCHES FROM PCT EUROPE

Strategic deals fit with regulators' risk-based site monitoring

08-Nov-2012 - Risk-based site monitoring is easier under strategic partnerships than other relationship models according to Covance.

Key Industry Events

 

Access all events listing

Our events, Events from partners...