Applied Clinical Intelligence (ACI) has launched iCommittees to provide a platform to support sponsors’ needs for clinical endpoint adjudication and data monitoring committees (DMC).
M&A can help revitalize firms but failure to properly integrate the companies can create an inefficient, demoralized business. In this article, Viq Pervaaz, senior vice president at Aon Consulting, takes a look at M&A processes, pitfalls and keys...
Ireland-based Firecrest Clinical says focusing on trial specific training and visits for principal investigators can speed recruitment, cut protocol deviations and produce cleaner data.
PhRMA, EFPIA, JPMA and the IFPMA have adopted a “joint position” that calls on member companies to submit summaries of all Phase III studies and those of “significant medical importance” for publication in peer reviewed journals.
Increased focus on post-market safety and value has resulted in CROs handling more Phase IV work, according to a PharmaNet EVP, and this trend may continue as regulators seek real world evidence.
The EMA has published its thoughts on monitoring overseas trials and will seek to establish an international network of regulators to develop and implement a robust oversight framework.
More than 50 per cent of large pharma keep all pharmacovigilance in-house but among smaller firms, and even some big businesses, outsourcing is considerable, according to a new report.
The US FDA should change its disclosure policy relating to manufacturing site inspections according to new draft recommendations by the Department of Health and Human Services (HHS) Transparency taskforce.
Increasingly complex clinical trials are making it difficult for biopharm companies to make time and cost savings and improve patient recruitment and retention, according to a report.
Datatrak has added Safety Export to its eClinical suite, reducing errors, shortening timelines and cutting costs by ending reliance on paper to exchange data between sites, sponsors and regulators.
MLawGroup and WS Partners are collaborating to offer pharma and biotech advisory services, including help in preparing and negotiating agreements with CROs and CMOs.
Hyde Engineering + Consulting has opened an office in Dublin, Ireland, enhancing its ability to provide Europe-based biopharm with compliance, qualification and automation services.
Clinical trials that finish early due to positive treatment effects often have misleading findings, according to a journal paper which recommends researchers resist pressures to end studies prematurely.
Liquent and Take Solutions say their new partnership provides pharmaceutical firms with an efficient, cost effective outsourced solution for regulatory publication and submissions.
Cambridge Major Laboratories (CML), Avantium, Xcelience and Beckloff have formed a consortium to offer tailored, client-focused CMC packages which are particularly suited to atypical compounds.
The US Food and Drug Administration (FDA) has issued guidance on the use of Bayesian analysis in clinical trials of medical devices and says the technique can cut costs and boost efficiency.
Improving healthcare infrastructure across the region and a large treatment-naïve patient population makes the Middle East and North Africa (MENA) an increasingly attractive destination for drug trials says ClinTec CEO Rabinder Buttar.
CRO Novella Clinical is providing OSI Pharmaceuticals with clinical research and related services over the next two years and will gain use of facilities in Boulder, Colorado, US as part of the deal.
Arizona moved a step closer to excluding federally regulated research facilities from animal cruelty laws yesterday after the Senate National Resources, Infrastructure and Public Debt Committee voted in favour of such a move.
The FDA has issued draft guidance detailing the information that should be submitted to an IRB as part of the continuing review of a clinical trial, with particular emphasis placed on the rise of multi-site studies.
US clinical trial review groups Independent Review Consulting (IRC) and Ethical Review Committee (ERC) are to merge and operate under the name Ethical and Independent Review Services (E&I).
US eClinical firm Phase Forward has created the new executive role, “chief privacy officer,” to ensure it complies with the latest data protection and privacy regulations governing the trial sector.
Irish CRO Icon has received a US Food and Drug Administration (FDA) warning letter relating to two studies of an antibiotic it conducted between 2004 and 2006.
PPD is targeting growing demand for contract data analysis with a new biostatistics infrastructure that, it says, offers improved security and reporting.
A MEP has questioned the EC’s estimate that 20,000 API producers supply the EU, which was used to justify not having mandatory inspections, and the CEO of Hovione added that the numbers have been “dramatically misunderstood”.
The market for contract manufacturing organisations (CMO) will be worth $33.7bn (€22.4bn) by 2014, according to a report which says developing biologics capabilities is a key imperative for growth.
Regulators, industry and academia must do more to close the knowledge gap created by a historic shortage of women in clinical trials, according to speakers at AAPS 2009.
Parexel has established The Expert Office to provide a single point of contact for clients which want the CRO’s team to assist them with optimising all aspects of the clinical trial process
Globalisation and “heightened awareness and scrutiny of clinical trials” in the wake of the Northwick Park, UK incident, where some patients suffered multiple organ failure, have had a significant impact on study insurance, according to a MD.
Comparative effectiveness research (CER) represents a “historical market opportunity”, according to a VP at Quintiles who explained that pharmas that do the work will be “properly rewarded for their innovations”.
Environmental and safety matters concern pharma “less than they should” when outsourcing to Asia, according to the CEO of Ash Stevens who believes there are long term benefits of using US-based companies.
A spectrum of systems could eventually replace animal testing and provide a more ethical and economical route through preclinical, according to Kate Darley, business development manager at Kirkstall.
Quintiles and Cerner are combining their “unique sets of experience and expertise” to improve the efficiency of late phase research, the market for which exceeds $1bn (€677m), according to a SVP at the CRO.
Hungarian drugmaker Gedeon Richter will use Phase Forward’s Clintrial software package to manage its study programmes under a deal signed late last week.
The AAHRPP has issued a major revision of its standards, the first time it has done so, adding sections on transnational research and the separation of business interests from ethics review.
MDS Pharma Services has become the first CRO in the UK and second in the US to gain certification from the Brazilian regulatory agency after a “major client” requested it sought accreditation.
US companies Savvion and Patni Life Sciences hope their new alliance help pharmas biotechs and CROs meet regulatory challenges “across the drug development cycle.”
Axiom Accelerated Patient Recruitment hopes its new range of SMS, text messaging, services can help CROs and pharma sponsors reach more potential study participants.
Clinical trials of cancer vaccines should enrol patients with no evidence of residual disease, according to FDA guidance, but this will increase development times compared to cytotoxic agents.
Fierce competition from India and China means it is unlikely that CROs and CMOs in CEE can generate sustainable growth, according to a report that believes the service model must be a “stepping stone” to creating innovative R&D businesses.
The Pan-African Clinical Trials Registry (PACTR) has become the first such database to be endorsed by the WHO, providing the world with access to studies on the continent and improving efficiencies.
US CRO Health Decision says the new “Monitor View” module for its HD360 trial management system makes assessing study site performance an easier and more cost effective process.
A US court has ordered the USDA to disclose 1,017 pages of animal testing documents relating to its investigation into HLS, despite testimonies stating that their release could be detrimental to the CRO’s business.
Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...
