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.
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.
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.
Increased use of adaptive clinical trials and biomarkers will benefit smaller laboratory services companies, according to Pacific Biometrics (PBI) that turned its operating income from loss to profit in fiscal 2009.
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.
ethica Clinical has added biomarker data analysis technology to its roster of services in a C$1.25m (€782,899) deal with fellow Canadian CRO Matrix Pharma.
GATC Biotech has expanded its human genome sequencing services and, having performed a pilot study, is “amazed” by the potential the techniques have for cancer research and diagnostics.
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.
A totally outsourced model of discovery is “probably valid”, according to a report that believes pharma must overhaul its operations because its business model is in danger of becoming “irrelevant”.
Lab Research (LRI) aims to boost its Korean presence in a new agency deal with Safe Chemicals that, CEO Luc Mainville says, will meet growing demand for large molecule contract R&D.
QPS’ bioanalytical laboratory in Taiwan is the first in the country to be certified as compliant with good laboratory practice (GLP) standards by the Department of health (DoH), according to unit president Vincent Yen.
Pharma companies can cut the risk of taking a TKI into Phase I by using the HemoRANK in vitro test, according to ReachBio that has developed the assay to evaluate a molecules clinical hematotoxicity.
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.
Orasi Medical claims CROs and pharmas can cut the cost and length of Alzheimer’s trials, and improve accuracy, by using its brain function measuring service, which is now being promoted in Japan.
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.
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.
US contract research organisation (CRO) Advion BioServices has expanded its biomarker business in an effort to meet growing industry demand for pharmacological analysis.
Aushon BioSystems has added laboratory and manufacturing capacity to its corporate headquarters to meet rising demand from clinical trials for some of its protein biomarker services.
Covance says its new clinical development offices in Brazil and Mexico will increase access to treatment-naïve patients and, ultimately, save pharmaceutical sponsors money.
US CRO and central laboratory services provider Pacific Biometrics (PBI) has entered into a $4m (€2.7m) loan agreement that it says will help further the development of its contract biomarkers business.
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.
Drug development partnering site goBalto’s addition of Latin American clinical sites to its database in a deal with Chilean CRO Clinical Trials Support (CTS) is timely given the pharma and biotech industry’s focus on emerging markets.
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.
Sigma-Aldrich is using a novel methodology to create rats with targeted gene deletion in as little as four months, which it believes could eliminate years of research and improve drug development.
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.”
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.”
India-based CRO Vimta Labs is aiming to lower the cost of diagnostic services by developing new panels using MassTag PCR technology licensed from Columbia University, New York.
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.
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.
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.
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).
US software company Velos hopes its new “software as a service” (SaaS) internet offering will attract CROs and Pharma firms seeking low-cost trial management solutions.
