The Dublin-based CRO has launched a next-generation electronic informed consent tool that incorporates some of the recommendations from the FDA’s recent draft guidance on informed consent.
With the aim of addressing the FDA’s recommendation for a more patient centric approach to presenting clinical trial information, the tool employs videos and visual aids to assist in the explanation of scientific concepts and medical terms found in trial protocols.
The world’s largest CRO announced a proposed offering of $800m principal amount of senior unsecured notes due 2023. The notes will be offered in a private placement that is exempt from the registration requirements of the Securities Act of 1933.
Quintiles said it intends to use the net proceeds of the offering, together with proceeds from its previously announced proposed new senior secured credit facility, to refinance its existing credit facilities, as well as for general corporate purposes, including corporate transactions and equity repurchases.
Evotec and Facio Therapies have agreed to jointly identify compounds with the potential to stop the progression of FSHD (Facioscapulohumeral dystrophy), a muscle wasting disease.
The project will include the set-up and execution of an automated high-throughput screen to identify small molecules having a positive effect on SMCHD1 and DUX4 activity in human FSHD-affected muscle cell lines. The compounds that show promising activity in this screen are expected to be available in the first half of 2016. The project may take several years before clinical testing in humans can begin, Evotec said.
Allergan has selected imaging software and CRO ImageIQ to provide clinical research imaging support services and technology for a safety and efficacy study of their LiRIS product in females presenting with interstitial cystitis with Hunner's Lesions.
Specifically, Allergan will leverage ImageIQ's imaging-enabled electronic data capture (EDC) system.
The privately-held digital health software and services provider of medical imaging analysis in clinical trials and daily clinical practice, has completed a $5.2m venture financing with Danish Research Foundation (DRF) and RBV Capital.
The new financing will be used to expand the company’s global client base and to further develop its proprietary software platform, as well as its clinical research services.
Ergomed’s co-development partner Aeterna Zentaris has received a positive recommendation from the Data Safety Monitoring Board (DSMB) for a Phase III study of ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer.
CEO Miroslav Reljanovic said: “The study is progressing well – patient recruitment is ahead of schedule with approximately 90% of patients enrolled.”
SDC, PRC Clinical
Statistics & Data Corporation (SDC), a specialized biostatistics and clinical data management CRO, and PRC Clinical, a clinical trial management expert CRO based in the Silicon Valley of California, have formalized their partnership by signing a Strategic Alliance Agreement.
The Society for Clinical Research Sites (SCRS), a global trade organization representing the interests of clinical research sites, and Total Clinical Trial Management (TCTM), a Dallas, Texas-based CRO, announced that over 500 clinical research sites have been awarded one-year SCRS memberships. The SCRS Site Scholarship Program awards membership to qualifying sites striving for excellence in clinical research who are not current or previous SCRS members.
Imperial, parent company to DAC Patient Recruitment Services, ClinicaLingua Translation Services, and Imperial Graphics, acquired Shepperton, UK-based Four Point Printing, which specializes in the production of printed clinical trial and regulatory materials.
Over the next several months, Imperial will be integrating systems and investing in infrastructure at Four Point, as well as expanding the capabilities of Four Point’s facilities to support both DAC Patient Recruitment Services and ClinicaLingua Translation Services.