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
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.
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.
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.
Hungary-based Ubichem Research has gained approval to supply cGMP radiolabelled APIs in the European Union (EU), positioning it to benefit from increased demand.
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.
Operating income at Medidata grew in the first quarter, underpinned by record bookings by contract research organisations (CRO) and rising revenues from Asia Pacific.
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.
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.
Indian CRO Siro Clinpharm says partnering with Taiwanese counterpart Virginia Contract Research Organisation (VCRO) furthers its geographical reach and access to patients.
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.
Russia, the Ukraine and Belarus have emerged as destinations for clinical studies and now offer “enormous” potential according to US-based CRO ClinStar.
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.
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”.
Thermo Fisher Scientific will take charge of clinical trial material production at Eli Lilly’s research technology facility in Indianapolis as the pharmaceutical firm further reduces in-house capacity to cut costs.
Clinical trials that finish early due to positive treatment effects often have misleading findings, according to a journal paper which recommends researchers resist pressures to end studies prematurely.
PPD has added capabilities at the facility acquired from Merck & Co and improved integration of other sites to create its Vaccines & Biologics Center of Excellence, a single provider of multiple laboratory services.
Compugen has developed a computer-based, in silico system which can assist drug delivery research by identifying peptides that have the potential to penetrate cell membranes.
Indian CMO Bilcare says need to test new drugs in diverse patient groups drove expansion of its cold chain clinical trial supply packaging and storage facility in Crickhowell, Wales.
INC Research is partnering with invivodata to add ePRO to its offering, selecting the eClinical firm over its competitors in part because it understands the “aggressive” approach the CRO takes.
Australia-based CRO TetraQ is doubling throughput of trial samples, resulting in a 30 per cent time saving for clients, by installing a Spark Symbiosis system at its site in Brisbane.
E Research Technology (ERT) launches Centralised Cardiac Safety 2.0 (CCS 2.0) service for ECG data and says approach improves efficiency, cuts costs and helps sponsors reach database lock quicker than distributed model.
Kendle has implemented a centralised biostatistics platform which will “create significant time savings” by improving global access to clinical trial data, according to the company.
An adaptive approach to both the design and operation of a clinical trial can boost efficiency, reduce timelines and cut costs says Health Decisions' CEO Michael Rosenberg.
OmniComm has launched a comprehensive Phase I eClinical tool, which it believes is the first of its kind, to help users make cost and time savings by improving efficiencies.
Trial planning can be a big challenge for small pharmas says US software group ClearTrial, which has launched a brand new contract study costing and optimisation service (SCOS).
URMC has set up the Center for Human Experimental Therapeutics (CHET) to help biotechs and academics advance product candidates from preclinical studies into trials in human.
BioClinica Optimizer has launched to allow users to simulate and optimise their clinical trials, providing information to identify potential supply shortages or excesses and study delays.
