Parexel has entered into an alliance with Mortara Instrument to bolster its early phase cardiac safety capabilities and improve the assesment of new compounds.
Canada’s Biovail Contract Research says its stand-alone biostatistics unit will help sponsors “anticipate roadblocks ahead of time and create a sound statistical analysis plan for optimal results.”
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
Ohio, US-based CTI Clinical Trial and Consulting Services (CTI) has bought German trial staffing specialist CRS Clinical Research Services (CRS) to build its presence in Europe’s contract research sector.
Quintiles is continuing to build alliances with large pharmas, inking deals to perform “the majority” of AstraZeneca’s (AZ) clinical pharmacology work and develop six oncology products in Eisai’s pipeline.
In Q3 Phase Forward’s revenues from CROs grew by 44 per cent year-on-year and it predicts a bright 2010, as a backlog of delayed trials are started and big pharma attempts to cut IT costs.
Novotech says its new “management hub” in Kuala Lumpur, Malaysia will serve as a base for expansion in the booming Asia-Pacific contract research sector.
inVentiv Clinical Solutions' new Clinical Global Alliance will help meet industry demand for rapid access to “concentrated patient populations” according to CEO Michael Hlinak.
Quintiles is collaborating with Guy’s and St Thomas’ NHS Foundation Trust and King’s College London to establish a 30 bed Phase I site which will help meet demand for early-stage research conducted in patients.
Australia-based CROs, state government and a clinical trails network are collaborating with a Japanese company to encourage businesses to outsource preclinical and early-stage research to Queensland.
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.
The CRO results season is underway with Icon and Covance both posting mixed Q3 figures as the challenges facing pharma, and businesses in general, continue to impact on operations.
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”.
Health Decisions is “effectively franchising” its clinical trial model to other CROs to create a network of partners that it believes will offer “great flexibility” to clients, according to its COO.
Encorium has abandoned plans to sell its Finnish unit, Encorium OY, citing its new strategic focus and recent contract wins as the basis for the decision.
ChemDiv’s subsidiary Chemical Diversity Research Institute (CDRI), based in Moscow, Russia, will carry out development work on a range of HIV antivirals on behalf of new drugmaker Viriom.
Lonza says that to the Indian market was a key motivation for its acquisition of Simbiosys Biowares India preclinical cell and molecular biology assets.
MDS Pharma Services’ Central Labs division is to be acquired by Czura Thornton, a private investment group that owns Chiltern, for approximately $8m (€5.4m) as part of the CRO’s repositioning.
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.
Following a “significant increase in demand” GVK Biosciences has partnered with Quantitative Solutions (QS) to develop and market clinical trial outcome databases, which they believe can improve drug development.
CROs believe that finding the right principal investigators is the hardest part of recruitment, according to a survey that adds that 80 per cent of respondents would prefer to reach enrolment goals 10 per cent quicker than cut costs by 20 per cent.
Hungarian drugmaker Gedeon Richter will use Phase Forward’s Clintrial software package to manage its study programmes under a deal signed late last week.
Diabetes focused drugmaker Diamyd Medical has called in CRO Inclinix Medical to help recruit patients for “rapidly expanding” late-stage trials of its candidate diabetes vaccine Diamyd.
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.
French neuroscience CRO Forenap Pharma has won the contract to conduct Phase I trials of an Alzheimer’s disease treatment candidate being developed by Swiss drugmaker Anavex Life Sciences.
ClearTrial has expanded its eClinical offering to create “the only system in the industry” that can provide fast and accurate project tracking, management of accrued liabilities and midstream study adjustments.
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.
Japanese CRO CMIC says rising demand for Medidata Solutions’ Rave EDC system in Asia drove its decision to seek top-level provider status under the US firm’s accreditation scheme.
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.
Improved access to data and the ability for users to share comments are among the features added to latest version of Veracity, an electronic data capture (EDC) system from Kika Clinical Solutions.
The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing a FDA audit.
The FDA is hoping to increase the likelihood of a clinical trial being successful by making best use of science and alternative study designs and has issued end-of-Phase IIa (EOP2A) meeting guidance to explain the process.
The Sentinel Initiative will help pharma and CROs pinpoint study objectives, according to a director at PRA who told Outsourcing-Pharma about the company’s postmarketing safety surveillance.
Funding increases have failed to boost pharma drug development productivity and, with budgets tightening, the industry must revise its operations to improve output, according to a research paper.
Quintiles has targeted Africa as the next non-traditional area to develop new medicines and the opening of its office in Ghana, which is now fully operational, is a major step in this process, Gillian Corken, head of Quintiles in Africa, told Outsourcing-Pharma.
Phase Forward has adopted technologies from BMC Software to improve its operational efficiency, make “substantial cost savings” and ensure its systems maintain the availability, reliability and compliance demanded by clients.
Recruiting patients with rare diseases for clinical trials could become easier if the US Congress passes a bill to allow patients on supplemental security income (SSI) benefits to receive compensation.
BioClinica is continuing to acquire companies in the wake of the collapse of its etrials bid, buying software and services provider Tourtellotte Solutions just over two weeks after its last takeover.
Virtify says the new online version of its Virtx CTRR system can help drugmakers comply with the increasingly complex disclosure rules that regulators worldwide apply to clinical trials, in an automated approach that saves time and money.
