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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.

News in brief

Synexus sets up Poland office

04-Nov-2013 - Patient recruitment firm Synexus has opened a new office in Wroclaw, Poland in the latest stage in in expansion in the country.

Quintiles ups EPS and narrows rev forecast

31-Oct-2013 - Quintiles issued a mixed set of revised financial predictions for 2013, increasing its earnings per share forecast after a surge of new business wins and narrowing its service revenue.

Covance reports strong Q3 with signs of early development recovery

30-Oct-2013 - Covance produced solid Q3 results as expected by analysts though whether the CRO can fire both early and late stage development cylinders at once remains a question. 

Parexel strikes another eClinical deal in Asia

15-Oct-2013 - Parexel has teamed up with Japanese trial management services firm Fuijitsu Systems West in an agreement that underlines the CROs eClinical growth ambitions in Asia.

Quintiles calls for voluntary, non-public release of masked clinical trial data

08-Oct-2013 - CRO Quintiles says it is in favor of the voluntary sharing of de-identified and masked clinical and preclinical data that protects the interests of research participants and proprietary data, though...

Almac launches online system to manage drug supply in trials

26-Sep-2013 - Almac has launched an online tool which it says will increase accuracy and save money in managing the supply of clinical trial supplies.

Update

InVentiv partnership will increase its access to trial site database

19-Sep-2013 - iCTRS (inVentiv Clinical Trial Recruitment Solutions) has partnered with ViS Research to accelerate the way it evaluates clinical trial sites.

Private Equity Group Buys eClinical Firm Bracket

22-Aug-2013 - Private equity group Parthenon Capital Partners has acquired eClinical services firm Bracket from US pharmacy benefit management organization Express Scripts.

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.