Genelux is an oncolytic virus company that was formed in 2001 and has been conducting clinical trials since 2009. The company completed four Phase 1 studies which have enabled it to design what CEO Thomas Zindrick describes as an advanced clinical program.
In May 2014, I interviewed Mithra Bindhu of India-based Asiatic Clinical Research to get an update on performing clinical trials in that country. The DCGI (Drug Controller General of India) had recently attempted to overhaul the entire system, which took a long time, complicated the process of conducting trials in India, and caused some sponsors to question the value of doing business there. Has the situation changed?
The recent clinical research tragedy in France that resulted in the death of one patient and the hospitalization of four others shocked many who work in the clinical research space. The adverse effects experienced by the previously healthy patients, reportedly involving deep brain bleeds, were both rare and disturbing.
ANSM, the national drug safety agency in France, has issued a timeline of the events that culminated in the death of one trial participant and the hospitalization of five others at a clinical trial performed at clinical research firm BIOTRIAL. As was speculated by researchers at the UK’s Royal Statistical Society (RSS) last week, the timeline confirms that all six of the volunteers who were hospitalized after the study received an escalation of the dose at the same time.
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.
In this whitepaper we review the key drivers impacting “traditional” biobanking and detail the challenges such biobanks face in delivering new biomarker-based research. To facilitate the discussion of approaches to overcoming these challenges, we introduce the concept of Next Generation Biobanking and define the attributes an “ideal” Next Generation Biobank would need to drive effective biomarker-based research. Finally we demonstrate the benefits of adopting a Next Generation Biobanking approach, with a case study in cancer biomarker discovery. By Mark A Collins Ph.D., BioFortis, Inc.
Clinilabs, a contract research organization (CRO), was selected by an international drug discovery and development company to provide full-service CRO management of a phase II primary insomnia program.
ICON is one of the world’s largest providers of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies.
ICON’s experience supporting early phase studies in subjects with renal and hepatic impairment, as well as our close contact with local IRBs, allows our team to expedite study start-up project activities and meet enrollment objectives.
MMS Holdings Inc. recently announced that it has successfully executed disclosure management services for several clients and is poised to make strides in this area with its proprietary software, TrialAssure.
Quanticate, one of the worlds leading data-focused CROs specializing in the provision of biostatistics, programming, data management, medical writing and pharmacovigilance services has been named category winner for Innovation in the 2013 CRO Leadership Awards presented by Life Science Leader magazine.
CRF Health, the developer of the TrialMax® Suite of electronic Clinical Outcome Assessment Solutions (eCOA) for the life sciences industry, becomes the first eCOA company to complete a full validation study for Professor Juniper’s ACQ and AQLQ questionnaires to the “Gold Standard” based on her recently released “Levels of Acceptability of Electronic Versions” rating system.
Stiris Research has entered into a strategic partnership with Statistics & Data Corporation (SDC) to offer seamless implementation of full-service Clinical + Biostatistics and Data Management/EDC solutions.
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.
Chief executive officer Dr. Emma Banks of Datatrial, a boutique clinical data organization, has accepted an invitation to join the Strategic Advisory Board of Bionow, a life science membership organization focused on the North of England.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, today announced that Tigermed Consulting Co., Ltd. has selected Merge eClinical's CTMS solution for Sponsors and CROs to streamline clinical trial management (CTMS) and maximize operational efficiency across its studies.
Darlene Panzitta, President and Founder of DSP Clinical, is among this year's PharmaVOICE 100 List of the most influential people in lifes sciences industries.
Synteract, Inc., a full-service contract research organization (CRO), will host the roundtable, “Beyond number-crunching and data-monitoring: challenging roles for CRO statisticians,” at the Joint Statistical Meetings (JSM), on August 1, 2012 at 12:30 p.m., PDT. The roundtable will be moderated by Jia Hu, biostatistician II, from Synteract. JSM is the largest gathering of statisticians held in North America, attended by more than 6,000 people.
Lophius Biosciences, a leading developer of novel T-cell based diagnostic testing systems, today announces the successful completion of a prospective multicenter clinical validation study for its T-Track® CMV/EBV tests
This quarter, DataCeutics, Inc. generously donated an iPad and a mobile iPad stand for patients in the Lehigh Valley Hospital Burn Center. Liz Dideon Hess, the Social Worker who provides emotional support to patients and family members coping with burn injuries said, “To call it a wild success would be quite an understatement!”