India’s Supreme Court has called for all of the data supporting the approval of 162 clinical trials between July and August of this year by the Drug Controller General of India.
Full-service CRO JSS Medical Research is extending its presence in Latin America permanently with the acquisition of LatAm Clinical Trials, a multinational CRO based in South and Central America.
Quintiles is looking into a new way of using biomarkers to speed the process of selecting patients for trials and new treatments, Quintiles Chief Medical and Scientific Officer Dr. Jeff Spaeder told us.
The panic behind the patent cliff for big pharma is now hitting generic companies, which are increasingly turning to service providers and consultants to help find solutions for holes in their pipelines.
The US FDA has finalized guidance on electronic case report forms (eCRFs), which offers advice for sponsors and CROs on how and in what cases to capture electronic source data.
CRO sales representatives do a good job of explaining the basics of their service offerings but they need to be more innovative in tackling sponsors’ individual challenges, according to a new survey.
CRO Harlan Laboratories, has expanded its specialty research production facility in southern Europe to provide its complete portfolio of contract breeding and health monitoring services to clients in Europe.
German CRO Evotec and the Harvard Stem Cell Institute have partnered to discover compounds that might prevent or slow ALS (amyotrophic lateral sclerosis) and other motor-neuron diseases.
CRO inVentiv on Monday announced a joint venture with the partners of the US lobbying firm Mehlman Vogel Castagnetti to help pharma companies further understand the health policy and regulatory landscape.
Soon sponsors and CROs seeking ethical approval for clinical trials in the UK will have to register them in a public database under the HRA's transparency plan.
In a first for CROs, INC Research has implemented an international accreditation program for its clinical research associates to further understand trial monitoring and ensure consistency for biopharma sponsors.
India’s top drug regulator on Wednesday unveiled a list of all the pending clinical trials before its apex committee, which includes information on what the top CROs are working on in the subcontinent.
Clinical trial sponsors are now asking CROs to do more as an industry and as the top contracting companies build teams of scientists and physicians as varied as some hospital chains, sponsors’ reliance on outsourcing may have yet to peak.
inVentiv Health company Adheris filed a lawsuit against the US Department of Health and Human Services (HHS) last week claiming that a new regulation imposes unconstitutional restrictions on part of its patient reminder business.
Covance’s IT expenses are expected to taper off in 2014, which could contribute to driving wider margins for the CRO, Covance CFO Alison Cornell said Monday.
As questions continue to be raised over the policies governing clinical trials in India, new regulations and amendments to the country's pharmaceutical laws are now coming to light.
CRO Covance has partnered with the Indiana Clinical and Translational Sciences Institute (CTSI) to conduct more Phase I research in the Midwestern state.
The US FDA has sent a warning letter to CRO Drug Research and Analysis Corp. founder and president Henry Frazer for failing to adhere to the agency’s regulations governing clinical trials.
CROs across the board saw revenue increase by more than 10% between 2011 and 2012, which was largely fuelled by Quintiles' growth, according to a new report.
CROs may see an uptick in sponsors requesting expedited pediatric trials as the US FDA has decided this week to begin posting online letters to sponsors that don’t meet deadlines for the trials.
CRO Pharmaceutical Product Development (PPD) on Tuesday announced it has acquired Acurian to help build its clinical trial patient enrollment and retention tools.
Duke University will play contract research organisation (CRO) for clinical trials of a Parkinson’s disease treatment being developed by International Stem Cell Corp (ISCO).
Private equity group Parthenon Capital Partners has acquired eClinical services firm Bracket from US pharmacy benefit management organization Express Scripts.
A Non-profit group focused on reshaping the clinical research will have started registering research sites as part of an effort to set up a global network.
CRO momentum in Asia is picking up as Icon has partnered with a clinical research centre at the National Taiwan University Hospital to accelerate drug development on the Chinese island.
The TransCelerate BioPharma industry group has launched its clinical trial comparator network to establish a reliable means for sourcing quality drugs for clinical trials.
Quintiles today announced it will expand its reach into the world of oncology, medical device and diagnostic trials with the acquisition of CRO Novella Clinical.
Agilent Technologies and SomaLogic will partner to expand the dissemination of Soma’s proteomic assay to at least five academic and contract research centers by the end of the year as demand for the tool has skyrocketed among biopharma companies.
The US FDA has finalized guidance on clinical trial oversight, calling for more remote and targeted risk-based monitoring, though some experts believe such monitoring should be more judiciously employed.
CRO Parexel’s revenue, net income and earnings per share grew substantially in Q4 when compared to the same quarter last year and the company expects similar growth in the next fiscal year.
CRO Covance is looking to help its biopharmaceutical and medical device clients manage their contract terms and associated payments better as some companies are losing almost 5% of US revenue from insufficient processes and contract management systems.
inVentiv Health and Oncobiologics are employing a unique risk-sharing partnership to bring a number of the biggest blockbuster biologics to market as biosimilars.
CRO INC Research opened two new locations in Osaka and Tokyo, Japan, to further expand the company’s reach to conduct trials in the highly sought-after Asian region.
The Supreme Court of India late last week ordered all state government health secretaries to meet with the national Secretary of the Ministry of Health to discuss ways to strengthen the framework for regulating clinical trials.
CRO Quintiles last week announced its fourth consecutive quarter of at least $1B in net new business, as well as 13% growth in the second quarter of this year, though analysts said the company did not meet bookings expectations.
Covance reported 10% revenue growth between the second quarter of this year and the same quarter last year, mostly due to central laboratories and late-stage development growth.
PRA CEO Colin Shannon tells Outsourcing-pharma.com merger with RPS will provide geographic and client base growth. Analysts say it is a positive move for two mid-sized CROs.
Private equity firm KKR announced today it will acquire RPS (ReSearch Pharmaceutical Services) from Warburg Pincus and will merge the company with PRA International.
