It has been approximately 10 years since Bayer’s medicine Nexavar was approved for the treatment of advanced hepatocellular (liver) cancer. Despite all of the research and money put into this effort since then, there has not been another drug approved for this disease. However, in April 2017, patients did finally see a new treatment (Stivarga) approved by FDA.
Collecting payments has long been an issue for clinical sites, especially those without the financial resources to withstand payment terms of 90 to 120 days. At the SCRS Global Site Solutions summit last fall, I even heard site personnel state they will pay less attention to studies where the sponsor or CRO does not make payments in a timely manner. We know that 40 percent of sites have cited slow payments as a primary operating concern. Financial stress at sites may even be negatively impacting the success of clinical trials.
For companies wanting to outsource their trials but also harbor concerns over CRO size and staffing, is there a solution? One group thinks they have come up with the answer. Four companies have come together to form a consortium designed to provide pharma with a dedicated team of trial experts focused on making studies more efficient and cost effective. Current members of the alliance include FMD K&L, inSeption Group, Pyxa Solutions, and OneSource Regulatory, with a plan to add more members in the future.
Pharma companies that conduct clinical research inhouse essentially get a 100 percent tax break on the expenses incurred from that research (about 70 percent of which are normally wages). If they instead outsource that research to a CRO, they may claim only 65 percent of eligible expenses. The CRO gets no tax break, so that 35 percent difference simply disappears. If a group of congressmen get their way, that situation might soon change.
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
On-site monitoring is one of the largest cost drivers in a trial, accounting for 30 percent on average of the cost of a clinical trial. Fifty percent of the cost of on-site monitoring involves ensuring data quality through source document verification (SDV).
The Coastal Carolina Research Center began using Clinical Conductor Site CTMS in 2008.
At inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.
On a global scale, the number of new molecular entities (NMEs) in development—and, more importantly, the number being approved by regulatory authorities— has dropped significantly in recent years.
You want a clinical trial management system (CTMS) that is simple enough for all stakeholders to use and that delivers results.
PRA, a leading clinical research organization, recently announced it was voted “Best CRO” for the 3rd annual BioPharma Asia Industry Awards 2013. The winner was announced March 19 at an awards dinner in Singapore.
WuXi PharmaTech, a leading contract research organization with operations in China and the United States, and PRA, a leading global clinical contract research organization, recently announced that they have signed a joint venture agreement to offer a broad platform of Phase I-IV clinical trial services in China, Hong Kong and Macau.
Spaulding Clinical Research Announces Collaboration with Blinded Diagnostics for centralized cardiac safety services for select pharmaceutical clients.
Spaulding Clinical Research has agreed to offer ECG services using the new Spaulding webECG Diagnostic ECG Management system for late stage clinical trials through Blinded Diagnostics.
Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) announces today that Immunovative Therapies, Ltd. ("ITL") has been granted regulatory clearance from Thailand authorities to advance its lead AlloStim™ immunotherapy product candidate to the Phase II/III clinical development stage in advanced metastatic breast cancer.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, will unveil a national mobile and internet platform for consumers and demonstrate how enterprise imaging solutions support achieving Meaningful Use objectives at the Radiological Society of North America (RSNA) in booth #4845.
Accelovance, an award-winning clinical services company, announced recently the addition of Stephan A. Bart Sr., MD as Chief Medical Officer for the organization.
Greenphire, the leading provider of payment technologies for the clinical trials industry, recently announced that a top 5 pharmaceutical company will use its ClinCard Technology Platform in a large, phase III clinical trial.
Early registrations have begun from clinical research professionals for the 9th PRO & eCOA Congress, hosted by PHT Corp., being held March 26-28, 2013, in Baltimore, Maryland.
Clinical Research Advantage, Inc. (CRA), a provider of a range of research services to pharmaceutical companies and contract research organizations (CROs), announced recently that its senior vice president of clinical operations, Kim Kundert, RN, BSN, CCRC, was named a finalist in one of the Best Executive (service businesses) categories in the 8th annual Stevie Awards for Women in Business.
DATATRAK International, Inc. (OTCQX: DATA), a leader in developing cloud-based, unified eClinical technologies and delivering related services for the clinical trials industry, today announced its participation at several industry events during the month of October.
INC Research, LLC, a therapeutically focused clinical research organization (CRO) with a Trusted Process® for delivering reliable results, recently announced the opening of a facility in South Korea to manage the growing demand for world-class clinical development programs. Located in the heart of Seoul's business district, the Company's South Korean team is primarily focused on study start-up and clinical operations activities around key therapeutic areas.
Chiltern International Limited (Chiltern), a global contract research organization (CRO), announced that Drs. Dieter Seitz-Tutter and Alexandra Adams have joined Chiltern, bringing their extensive expertise in clinical research to serve our clients’ needs and to strengthen our Global Clinical Development service.
QPS, LLC, a leading full-service GLP/GCP-compliant contract research organization providing testing services to support preclinical and clinical research and development, announced the acquisition of a majority interest in JSW Life Sciences GmbH. JSW provides preclinical and clinical Phase II – IV drug development services to pharmaceutical and biotech companies worldwide, and will be known as QPS JSW.