Applied Clinical Intelligence (ACI) has launched iCommittees to provide a platform to support sponsors’ needs for clinical endpoint adjudication and data monitoring committees (DMC).
Quintiles’ Jay Norman tells Outsourcing-pharma that data sharing and patient and payer concerns will drive drug industry competition and clinical development decisions accord to new research.
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.
Quintiles is establishing its first Prime Site in Asia by entering into a strategic alliance with the University Malaya Medical Centre (UMMC) in Malaysia.
The opening of a New York office will help communicate Clintec’s global reach to US Pharmaceutical according to new associate director of US business operations, Susan Pavone.
Indian CROs Max Neeman International and QED Pharmaceutical Services have both added US Food and Drug Administration’s (FDA) CDISC compliance to their data management offering this month.
Demand for biomarker analysis is strong, but the pace of technological change is causing an investment headache for CROs according to a new report by Industry Standard Research (ISR).
The Singaporean government has launched two new certification courses for clinical researchers in a bid to “deepen the pool of skilled manpower” available to the country’s rapidly expanding contract research sector.
A US group representing hospitals in New York wants to accelerate clinical research process by improving trial access to electronic patient records, while maintaining patient privacy.
US CRO Kendle has opened a new services centre in India, attracted by the country’s thriving contract research sector and favourable climate for clinical trials.
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.
The ACRO says greater regulatory harmonization, expansion of trial registries and clarification of liability issues are needed to address the “alarming” drop in number of investigators participating in trials in US and Europe
Bristol-Myers Squibb (B-MS) has inked deals with Icon and Parexel to support the large volume of clinical development work it expects to perform in coming years.
CRO PFC Pharma Focus is using a HMO database to provide feasibility information before a clinical trial starts, reducing costs, risks and developmental timelines.
US CRO Quintiles expands PI3K assay offering, predicting increased drug industry demand for expertise in key survival pathway in era of personalised cancer treatments.
Chiltern’s early phase unit in Dundee, Scotland has achieved supplementary accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA).
US-based contract research organisation (CRO) Novella Clinical has acquired Prologue Research to enhance its offering of oncology clinical trial services.
Celerion has implemented a hybrid ECG core lab across its Phase I network to help clients get through this early developmental stage “much cheaper and much faster”.
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.
Clearstone Central Laboratories is to wind down or sell its centralised cardiac services (CCS) business because significant investment would be required to remain competitive.
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.
Contract research organisation (CRO) Quintiles Transnational has boosted its UK marketing teams through a deal with Nycomed but is planning cutbacks at US operations in RTP.
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.
Contract research organisation (CRO) Chiltern says new Australia and Singapore offices are a natural progression for its contract research business in the Asia-Pacific region.
CRO Quintiles says Southern California Permanente Medical Group (SCPMG) partnership will improve patient recruitment and, ultimately, accelerate the drug development process.
Encorium has posted a $1.9m (€1.6m) operating loss in the first quarter, with contract cancellations and reduced new business driving net revenues down by almost 34 per cent.
Operating income at Medidata grew in the first quarter, underpinned by record bookings by contract research organisations (CRO) and rising revenues from Asia Pacific.
Parexel has opened two offices in China, expanding its presence in Asia Pacific to 17 sites, as part of efforts to provide cheaper, faster drug development services.
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.
Operating income at Kendle fell by 48 per cent in the first quarter, driven by a dip in net revenues, but the CRO is encouraged that improvements in April suggest the market is improving.
Covance has cut its full-year guidance despite an increase in Q1 revenue, citing delayed late-stage trials, lower demand for chemistry services and costs associated with facility closures as the reason for the adjustment.
Cardiac monitoring and ePRO specialist ERT has added respiratory diagnostics and device manufacturing services to its offering with the acquisition of CareFusion Research Services (CRS) for $81m (€61m).
Norwich Pharmaceuticals is expanding beyond its traditional manufacturing focus by launching a CRO in India to provide clients, and its parent company Alvogen, with clinical research services.