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”.
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.
PPD and Southern Research are collaborating to strengthen their pandemic and seasonal influenza development services by working together on client bids and projects.
Indian CRO GVK Biosciences hopes new clinical pharmacology unit in Ahmedabad will help boost patient recruitment to meet growing demand for clinical trials in the region.
Quintiles has relocated its global central laboratory in Japan to meet rising demand from the local market and US and European pharmas keen to include the country in their clinical trial network.
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.
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.
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.
US CRO PPD has been busy on both sides of the Atlantic, opening a clinical testing facility in Ireland and, in the US, moving forward with plans to spin-off its compound partnering business as Furiex Pharmaceuticals
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.
MedNet Solutions is introducing iMedNet, a pay-as-you-go web-based EDC platform to support collaboration and communication between clinical trial stakeholders.
Kendle posted a 37 per cent drop in operating income in 2009 and will lay off employees this quarter in response to the market’s “continued volatility” and late stage cancellations.
Parexel has opened a 40 bed early phase clinical trial unit in South Africa, increasing its Phase I capabilities in the country and adding to its patient recruitment focused SuperSites network.
US Pharma firms can benefit from the sourcing, storage and distribution efficiencies offered by comparator drug sourcing and distribution specialist Pharmarama says managing director Rosemary Bensley.
Almac Clinical Services says novel temperature monitoring system speeds shipping and cuts quarantine times by allowing authorised personnel to make decisions on trial supplies at clinical sites 24/7.
Clinical trials are often biased against the recruitment of older people says the European Union's PREDICT group, which has launched a charter designed to protect such patients' right to take part.
The US Food and Drug Administration (FDA) has issued guidance on the use of Bayesian analysis in clinical trials of medical devices and says the technique can cut costs and boost efficiency.
Parexel has formed an alliance with Proteome Sciences to enhance its biomarker capabilities, allowing it to help clients make earlier assessments of new compounds in development.
Using intelligent compliance packaging in clinical trials can result in “huge cost savings” and this will ensure demand even during a period of cost-cutting, according to a sales manager at Stora Enso.
Consolidation in pharma, coupled to the trend for strategic partnerships, will lead to CRO mergers, with large companies getting bigger and small firms focusing on niche opportunities, according to a report.
SIRO Clinpharm has formed an alliance with South Korea-based CRO DreamCIS to expand its clinical trial offering in Asia Pacific and provide clients with more options for patient recruitment.
Integrated solutions are the future of trial data management according to Phase Forward as growth of the electronic data capture (EDC) market begins to slow.
BioClinica is providing Cephalon with end-to-end clinical data management services and hiring some of the biotech’s staff under a three-year, multi-million dollar deal.
Improving healthcare infrastructure across the region and a large treatment-naïve patient population makes the Middle East and North Africa (MENA) an increasingly attractive destination for drug trials says ClinTec CEO Rabinder Buttar.
Oracle Health Sciences has launched pharmacovigilance software Argus Safety Suite 5.1 to help pharma and CROs meet regulatory compliance and support safety processes from clinical development through post-marketing.