Global News

Factory-CRO launches clinical trial rescue program for medical devices

Wednesday, July 16, 2014 01:17 PM

Factory-CRO, a medical device CRO based in the Netherlands, has announced a new early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by the FDA or European regulators.

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WIRB Copernicus Group

Eli Lilly, Immunocore collaborate for novel cancer therapies

Wednesday, July 16, 2014 01:15 PM

Eli Lilly and Immunocore, a privately owned, clinical-stage biotechnology company, have entered into a co-discovery and co-development collaboration to research and potentially develop novel T cell-based cancer therapies.

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Clinical Conductor CTMS launches configurations

Wednesday, July 16, 2014 01:14 PM

The Clinical Conductor CTMS team has launched CTMS configurations for Clinical Conductor. These configurations are designed for research sites, site networks, CROs, hospitals, health systems and sponsors. With CTMS configurations, Clinical Conductor now provides unique feature sets and functionalities required by different types of research organizations to operate most effectively.

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Theorem Clinical Research, Excel Life Sciences partner

Wednesday, July 16, 2014 01:13 PM

CRO Theorem Clinical Research and Excel Life Sciences (ELS) have formed a strategic relationship to bolster Theorem’s clinical development offerings in India, including local site management experience. ELS has long-standing relationships with more than 1,000 hospitals and research centers across 25 cities throughout India, covering a broad range of therapeutic disciplines.

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Harlan Laboratories, Fluofarma collaborate

Wednesday, July 16, 2014 01:10 PM

Harlan Laboratories, a privately held provider of general and specialty toxicology services through its Contract Research Services (CRS) business, and Fluofarma, a CRO specializing in high content analysis, have partnered to strengthen the companies’ drug discovery and translational medicine services.

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Chiltern acquires Ockham, strengthening oncology, CRO services, job placement

Tuesday, July 15, 2014 03:38 PM

U.K.-based Chiltern, a 32-year-old global CRO specializing in oncology services and a range of other therapeutic areas, has acquired Ockham, a 28-year-old oncology-focused CRO, and the two companies will merge their operations.

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FDA approves IDE for VENITI VICI Venous Stent System

Monday, July 14, 2014 01:33 PM

Veniti, a provider of innovative technology for the treatment of venous disease, announced has received approval from the FDA for an Investigational Device Exemption (IDE) to begin the VIRTUS trial of the VENITI VICI Venous Stent System. The VICI Venous Stent System was designed from inception to be compatible with the unique anatomy and pathophysiology of the venous system. Hundreds of thousands of people around the world suffer from lower-extremity venous disease, and until recently, the only treatment options available involved the use of re-purposed vascular stents originally designed for use in the arterial system.

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Health Canada approves APTIOM (eslicarbazepine acetate) for epilepsy

Monday, July 14, 2014 01:13 PM

Sunovion Pharmaceuticals Canada has announced that Health Canada approved APTIOM (eslicarbazepine acetate) for use as a once-daily adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy. APTIOM is not indicated for use in patients under 18 years of age.

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Covance adds two to clinical development services leadership team

Monday, July 14, 2014 01:04 PM

Covance has announced two key additions to its clinical development services scientific leadership team with the appointments of Robert Wasserman, M.D., as vice president and global therapeutic area head, oncology, and Rogelio Mosqueda-Garcia, M.D., Ph.D., as global vice president, early clinical services within medical and scientific affairs. Both are based in Princeton, N.J.

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Merck's biopharmaceutical division appoints Luciano Rossetti global head of R&D

Monday, July 14, 2014 12:59 PM

Merck's biopharmaceutical division has appointed Luciano Rossetti, M.D., executive vice president and global head of R&D as of July 21.

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August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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