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.
Quintiles believes there is a “dire need” for trial sites that can raise standards and reduce inefficiencies in the clinical research process and is expanding its Prime Site programme to meet this demand.
Colorado trial support services group nSpire Health says its Koko spirometry and PiKoLogic ePro technologies were crucial factors in winning more than $9m (€6.1m) worth of clinical research contracts.
Canadian group Clinical Logistics (CL) and US analysis specialist Gentris have teamed up to develop a dedicated low temperature storage service for clinical cell and DNA samples collected during drug trials.
Hyderabad, India-based Makro Care says its GCP “helpdesk” website has already proved to be an invaluable information source for contract research organisations (CRO), investigators and pharma trial sponsors.
The new partnership with Indian CRO Abridge Clinical Research (ACR) is a unique collaboration offering cost efficient and timely trial solutions according to Global Pharmaceutical Services (GPSI) spokesperson Keith Russell.
Russia-based CRO SynRG has cut the time to prepare a detailed proposal from two weeks to two hours, giving the company a competitive advantage over its rivals, and established a presence in the US to target small to mid-sized companies.
The outsourcing “market is poised to return to healthier growth rates in 2010”, according to the president of MDS Pharma Services who also told Outsourcing-Pharma that CROs will play an increasingly important role in drug development.
Covance says its new clinical development offices in Brazil and Mexico will increase access to treatment-naïve patients and, ultimately, save pharmaceutical sponsors money.
Encorium has outlined plans to specialise in vaccines, which it believes is an area it can be more flexible than big CROs, and inked a swine flu deal as part of $8.7m (€6m) of new contracts.
CRO Averion is planning to become a private company to reduce expenditure on auditor fees, which could realise savings of $805,000 (€561,000), and allow management to better focus on long-term goals.
Following a review of the backlog of postmarketing studies the FDA has initiated changes to improve its processes, including developing Manuals of Policies and Procedures (MAPP) to track the status of trials.
AstraZeneca (AZ) has dramatically cut the time taken to initiate a Phase I oncology trial by working with its strategic partner to improve administrative processes and eliminate delays, according to research.
An “enormous leap in productivity” can be achieved by applying the principles of adaptive trials to broader operations, such as recruitment, according to a CEO that thinks CROs have to adopt the method.
Synexus is meeting the rising demand for its services, which it says can dramatically increase recruitment rates, by acquiring clinical trial sites in Poland and is hoping to expand in India soon.
The number of registered clinical trials in Russia slipped in Q2, with the country attracting fewer international sponsors and regulatory inspections than in pervious years.
US analysis group CRL will set up a new laboratory at Quotient Bioresearch’s facility in Cambridge in the UK, in a collaboration designed to expand the US company’s business on the global stage and extend Quotient's offering.
Xceleron will provide services to GSK and its collaborators, such as academics and biotechs, under a novel deal that emphasises the big pharma’s attempts to change its drug development model.
US drug giant Pfizer has joined the growing list of organisations seeking to boost trial recruitment via the web, teaming up with IT firm Private Access to create a website designed to “increase clinical trial awareness and participation.”
Bias in publications in medical journals is facing intense scrutiny again, following media reports GSK used a ghostwriting programme and separate research into combating the problem.
A new partnership between CenterWatch and TrialX may help boost flagging recruitment rates by “helping patients more easily and rapidly connect with relevant clinical trials.”
Datatrak believes that to compete against the eClinical giants companies should focus on a specific niche and hopes this plan will help it post a profit after recording a small loss in Q2.
Medidata has followed its successful IPO by posting an operating profit in Q2, having made a loss last year, and giving a positive outlook for the rest of the year.
Accounting errors related to the purchase of ClinPhone reduced Parexel’s operating income by $15.9m (€11.2m) in fiscal 2009 and the impact of these charges will continue into the next year.
Pharsight has launched PKS Online to provide small companies with a PK/PD data and analyses storage system, which it claims saves users money and can improve early-stage development.
The US Food and Drug Administration (FDA) has enhanced its debarment and disqualification procedures to ensure clinical trial investigators meet legal requirements.
OmniComm has acquired Logos Technologies’ electronic data capture (EDC) assets, the second deal of this type it has made in the past 6 weeks, further strengthening its presence in the market.
The FDA and EMEA are launching an 18 month pilot programme focused on good clinical practice (GCP), which is intended to increase collaboration and reduce the burden on the agencies.
eResearch Technologies (ERT) posted a Q2 operating income of $4.8m (€3.4m), down from $10.8m last year, and attributed the decline to companies delaying thorough QT trials.
US pharmaceutical giant Pfizer has teamed up with China’s Fudan University to set up a Master’s degree programme in clinical data management and statistical programming.
Ecron Acunova’s global partnering team had a busy end to July with the Indian CRO entering into collaboration deals on both sides of the Atlantic to further expand its global reach.
US firm Isogen says the combination of aseptic filling, engineering and containment know-how on offer at its new Science Center is unique among facilities serving the clinical market.
Glenmark Pharmaceuticals and Omnicare have closed a clinical trial site in India operated by the contract research organisation (CRO) amid accusations that an investigator acted fraudulently.
Clinical trials in the developing world meet the same standards as those in Europe and the US and are vital for accelerating drug development says the Association of Clinical Research Organisations (ACRO).