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.
The CRO and eClinical results period is underway, with Icon, Parexel, Phase Forward and OmniComm publishing generally positive financials in the past two days.
Integration expenses, lower revenues, higher R&D spending and rising corporate costs impact PPD in Q1, but cancellations back to normal levels and requests for proposals increase.
US CRO Medpace has move into medical device trials with acquisition of Symbios Clinical in a bid to tap into what CEO August Troendle said was a growth area for the contract research sector.
ACRO is aiming to increase recognition and analysis of the value CROs bring to drug development, spanning their role as strategic partners throughout the process, by funding academic research.
Datatrak has added Safety Export to its eClinical suite, reducing errors, shortening timelines and cutting costs by ending reliance on paper to exchange data between sites, sponsors and regulators.
KryoTrans International claims its developmental KT1500 reusable container for drug shipments will be first passive temperature-controlled unit capable of accepting pallets and a boon for CROs in the globalised trial sector.
Indian CRO Siro Clinpharm says partnering with Taiwanese counterpart Virginia Contract Research Organisation (VCRO) furthers its geographical reach and access to patients.
PRA has expanded into New Zealand, complementing its Asia-Pacific network and establishing a point of contact for pharmas interested in benefiting from the county’s high recruitment rates.
IT giant Oracle will pay $685m (€507m) for eClinical solutions firm Phase Forward, significantly expanding its presence in the billion dollar contract clinical research sector.
ePharmaSolutions has launched Clinical Trial Portal (CTP) 4.0, adding new capabilities including electronic monitor visit report (eMVR) and improved site feasibility application (SFA).
Perceptive Informatics has added industry standard performance metrics to its medical imaging capabilities, allowing users to track progress against Metrics Champion Consortium (MCC) criteria.
Russia, the Ukraine and Belarus have emerged as destinations for clinical studies and now offer “enormous” potential according to US-based CRO ClinStar.
ClearTrial has launched an upgrade to its clinical trial operations (CTO) software, adding more country specific knowledge, such as labour rates, to help companies forecast costs and timelines.
Aris Global has introduced Total Clinical 2.0, a software package which integrates EDC, safety and adverse event systems to streamline operations and cut costs.
Chiltern has invested in endpoint to establish a strategic relationship which allows it to offer an IRT capable of cutting timelines and costs, a company EVP told Outsourcing-Pharma.
Almac has launched an online tool that allows trial sponsors to view, trace and amend trial material labels from anywhere in the world which, it claims, will improve and accelerate the approval process.
Datatrak recorded a $1.9m (€1.4m) operating loss in 2009, and revenue declined by 31 per cent, but believes measures it has taken have laid the foundation for the coming year.
The FDA’s draft guidance on adaptive design in clinical trials is a balanced, practical publication, according to the EVP of a CRO who expects the document to generate a “robust discussion”.
