Parexel’s future course may depend on the outlook of competing CROs (contract research organizations), a couple of which could potentially go public in the near future, Ingo Bank, SVP and CFO of Parexel, said Wednesday at the Baird 2014 Healthcare Conference.
Ohio-based CRO (contract research organization) Ricerca Biosciences is holding “ongoing discussions with several parties” about the possible sale of one or more of its divisions or the entire company, CEO Tim Derrington told us.
Industry group TransCelerate Biopharma has developed a new recommended approach for protecting patients’ personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others as part of plans to release more data under consideration...
A former researcher of the now dissolved CRO Cetero Research told us the warning letter he received from US FDA was “contrived” because of the way the inspection was conducted.
Contract research organisations (CROs) are turning to technology to fight dual patient enrolment in trials, but rival service companies refuse to sync their methods, says an early-phase expert.
Regulators are showing interest in a database of clinical trial endpoints to cut redundant research, although contract research organisation Parexel has expressed reservations.
CROs must design their abuse liability studies to cope with volunteers who arrive under the influence or give misleading patient histories, says a specialist consultancy.
As the US FDA, EMA and Japan’s PMDA have released guidelines and related position papers on multi-regional clinical trials, the ICH is now proposing to do the same but with a more multi-national approach.
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 the investigation was conducted according to plan.
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 by Outsourcing-Pharma.com of trials in clinicaltrials.gov.
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 the next several years, Ge Li, chairman and CEO of WuXi, said.
CRO Chiltern International has purchased a Gold Membership from non-profit standards consortium CDISC (Clinical Data Interchange Standards Consortium).
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.
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 Rickenbach predicted in the company’s earnings call last week.
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.
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 the replacement, reduction and refinement of...
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 subsidiary Aptiv Solutions.
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 continuing to make up half its revenues.
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 the same time, small biotech, with their plethora of funding, are starting...
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 R&D tax credit when research is outsourced.
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 on a crowdsourcing strategy to establish...
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 expected early phase development and central labs work.
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 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 preclinical HIV/AIDS work.
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.
Germany-based full-service CRO (contract research organization) Accovion has expanded European presence with new offices in Italy, France and Eastern Europe.
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).
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.
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 improve the conduct of clinical trials...
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.
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 announced.
While the overall bioscience industry has seen 7.4% jobs growth between 2001 and 2012, the sector encompassing CROs and other research, testing and medical labs has grown by more than 28%, according to a new report from industry group BIO and Battelle.
The Association of Clinical Research Organizations (ACRO) offered a number of recommendations to the US House Energy and Commerce Committee’s “21st Century Cures” initiative last week as part of an effort to keep the US research industry competitive globally.
The Management Board of the EMA (European Medicines Agency) has postponed the formal adoption of its policy on publication of clinical trial data, though the agency stopped short of revealing exactly why.
European drugmaker Nicox has agreed to acquire all of the outstanding equity of US-based Aciex Therapeutics, an ophthalmic development company, which will also be a boon for ophthalmic CRO Ora.
The latest draft revisions of the Declaration of Helsinki (DoH) weaken protections for trial participants in low and middle income countries, Rafael Dal-Ré, director of clinical research at Universidad Autónoma de Madrid, and other researchers argue.
Sponsors and CROs must ensure that clinical studies are properly designed and that investigators work on a maximum of three trials simultaneously under new guidelines issued by Indian regulators.
The Center for Responsible Science has asked the US FDA to adopt informed consent rules which ensure that trial participants know the experimental drugs they receive may be unsafe or ineffective.
CRO Parexel has shifted its attention overseas with the acquisition of Atlas Medical Services, a provider of clinical research services in Turkey, the Middle East, and North Africa.
Contract research organisations (CROs) have been slow to adopt next-generation means of recording study documents, with only 13% using the most up-to-date technologies, according to cloud-based services company Veeva.
Three years after Pfizer began strategic partnerships with CROs Icon and Parexel, and the companies are still ironing out differences and tweaking their relationships, Mark Sanders, senior director of global sourcing, told attendees at DIA’s annual conference.
Small biotechs thinking of outsourcing should carefully weigh up the pros and cons say industry experts, who warn that for firms that do contract out clinical development choosing the right CRO is vital.
Parexel has predicted ten per cent year-on-year revenue growth for FY2015 but has been more modest about its operating margins ahead of its Investor Day tomorrow.
