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Headlines > Clinical Development

Former Cetero researcher hit with US FDA warning letter

20-Aug-2014 - A researcher with the now dissolved CRO Cetero Research received a warning letter released Tuesday from the US FDA after inspectors found that he, among other things, failed to ensure that...

Small molecule, biologics manufacturing drive WuXi growth in Q2

18-Aug-2014 - With almost 20% year-over-year growth in its manufacturing services, Chinese CRO and CMO WuXi now expects its small molecule manufacturing and biologics to be the key drivers of growth for...

Top CROs dominate competition in trial totals, review finds

18-Aug-2014 - A breakdown of trials run by the top contract research organizations (CROs) reveals that the big players are leaving little room for smaller firm to compete, according to a review...

Chiltern becomes a member of CDISC

14-Aug-2014 - CRO Chiltern International has purchased a Gold Membership from non-profit standards consortium CDISC (Clinical Data Interchange Standards Consortium).

Venn acquires part of French CRO for about €500k

12-Aug-2014 - In its third acquisition in the past 10 months, European CRO (contract research organization) Venn Life Sciences has acquired Cardinal Systems, a France-based CRO specialising in data management and randomisation systems.

Biotech cash to be a boon for CROs, Parexel says

11-Aug-2014 - As small and medium sized biopharma companies continue to raise cash through IPOs and elsewhere, CROs will see an uptick in outsourced work, Parexel founder, chairman and CEO Joseph von...

Quintiles partnership to offer companion diagnostic services in China

07-Aug-2014 - Roche subsidiary Ventana Medical Systems has agreed to partner with Quintiles to offer companion diagnostic testing services in China for pharma and biotech clients conducting early phase clinical trials. 

Pfizer, Roche join consortium of adaptive trial sponsors

05-Aug-2014 - Pfizer and Roche have joined a consortium of clinical trial sponsors that are looking to design and implement adaptive trial designs. The consortium was partly founded by CRO Icon’s new...

EMA concept paper focuses on quality control with animal tests

05-Aug-2014 - The European Medicines Agency (EMA) has issued a concept paper  on transferring quality control methods validated in collaborative trials that is intended to encourage the uptake of better tests in terms of...

Icon's robust Q2 driven by strategic partners and new clients

05-Aug-2014 - Icon has picked up new clients and expanded existing contracts in a robust Q2, but the CRO says it has seen no overall shift in its client concentration with strategic partners...

NIH looks to crowdsource and repurpose older drugs

04-Aug-2014 - This summer, the National Institutes of Health (NIH) announced another funding opportunity for experimental drugs proven safe but sitting on the shelves of pharmaceutical companies.  The NIH-sponsored effort is based...

US Senate bill to offer CROs a share of R&D tax credit

04-Aug-2014 - Sen. Tom Carper (D-Del.) introduced a bill last week that aims to further incentivize research in the US and allows CROs (contract research organizations) to capture a share of the...

Quintiles sees strong demand from large pharma

04-Aug-2014 - Quintiles CEO Tom Pike told investors last week that the company is seeing “very strong demand from the larger pharmaceutical firms because their pipelines are full right now,” and at...

Covance finds early phase work rebound in Q2 as central labs growth continues

31-Jul-2014 - The season of quarterly reports is in full swing, with CRO Covance seeing its income and revenue rise in Q2 compared with the same quarter last year due to stronger-than...

Global trials growth driving CRO consolidation, says M&A report

29-Jul-2014 - Increased emphasis on global clinical trials is promoting consolidation of contract research organisations (CROs), according to an industry report by M&A services firm 11T Partners.

SRI International wins $49m NIH contract to study new HIV, AIDS therapies

29-Jul-2014 - SRI International was awarded a seven-year, $49m contract from the NIAID (National Institute of Allergy and Infectious Diseases), which is a division of the NIH (National Institutes of Health), for...

Strategic alliances can benefit SMEs as well as Big Pharma, says CRO DZS

28-Jul-2014 - Strategic partnerships are “flexible, cost-effective and will become the trend over the next few years,” says CRO DZS, which has signed a multi-year deal with SBI Pharmaceuticals.

Accovion continues expansions across Europe

23-Jul-2014 - Germany-based full-service CRO (contract research organization) Accovion has expanded European presence with new offices in Italy, France and Eastern Europe. 

Biosimilar trials: the ‘under the radar’ sourcing race

23-Jul-2014 - Timescales and sourcing comparator biologics are the biggest challenges for biopharmas running biosimilars studies, says an expert.

CRO SynteractHCR recognized by Swiss for clinical training program

22-Jul-2014 - A Swiss association has recognized the European Centre for Clinical Research Training (ECCRT), a SynteractHCR company, for training investigators and sub-investigators on GCP (good clinical practice).  

Indian clinical trial approvals see early spike in 2014

21-Jul-2014 - The approval of clinical trials in India is rebounding in 2014 after a year in which the country’s regulations were in constant flux.

ACRES, inVentiv partner to help develop global trial standards

17-Jul-2014 - CRO inVentiv’s Clinical Trial Recruitment Solutions (iCTRS) and the non-profit Alliance for Clinical Research Excellence and Safety (ACRES) are partnering to accelerate the development of a global standards system to...

FDA offers new draft guidance on informed consent process

17-Jul-2014 - For the first time since 1998, the US FDA is offering draft guidance on what it expects from IRBs (institutional review boards), clinical investigators and sponsors regarding informed consent.

Update

Theorem pushes further into India as regulatory hurdles mount

16-Jul-2014 - CRO Theorem Clinical Research and Excel Life Sciences have formed a strategic relationship to bolster Theorem’s clinical development offerings in India just as regulations begin to shift on the subcontinent....

Chiltern taps oncology expertise with Ockham acquisition

16-Jul-2014 - UK-based CRO Chiltern has agreed to acquire Ockham, a North Carolina-based full-service CRO, and the combined company will now compete with mid-sized CROs. Financial terms of the acquisition were not...