The cost of new drug discovery has skyrocketed in recent years, and is something that should have everyone in the drug discovery industry concerned. Sergei Varshavsky, M.D., Ph.D., and senior VP of global strategy for contract research firm Synergy Research Group (SynRG), notes it was not always this way. Some of the greatest medicinal discoveries in the history of mankind were inexpensive to develop and test. “There was the discovery of the smallpox vaccine in 1796, ether anesthesia in 1846, and insulin and penicillin in the early 20th century,” he says. “None of them cost much. In fact, the patent for insulin was sold to the University of Toronto for a half-dollar. Despite the low cost, these drugs have saved billions of lives.” Unfortunately today’s medical community is no longer able to accomplish similar feats for such a low cost.
Continuing with the review of the key points in FDA’s guidance. This is the second of three postings. By Bart Cobert
J&J executives realized that to design the clinical trial process in the future they would have to look outside their walls and collaborate.
Craig Lipset discusses the lessons learned from Pfizer’s REMOTE clinical trial was conducted with less than stellar patient responses.
With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.
Merge CTMS for Investigators offers groundbreaking ease-of-use, power, and flexibility, helping you organize and centralize your clinical research. Scalable, secure, and backed by the most comprehensive customer support program in the industry, Merge CTMS is the site success solution.
Today, 8 of the top 10 pharmas and 6 of the top 10 CROs use ARX’s CoSign® digital signature solution to help them benefit from fully electronic regulatory document lifecycles, compliance with various FDA GxP regulations, and efficiency in supporting audits.
Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.
A solid outsourcing strategy is critical to leading your organization to a successful outsourcing experience. Of course every organization in need of outsourced services must consider their priorities: Is it cost? Timelines? Team experience? Some combination? Inevitably the salient considerations are a combination of each of these factors, yet some will be weighed more heavily than others. By Kevin Boos, RDP Clinical Outsourcing, Scott Connor, Acurian, and Meenal Patel, RDP Clinical Outsourcing
A whitepaper describing how a Unified Approach enhances the safety, simplicity and speed of clinical trials.
One of the many challenges in conducting clinical trials is the speed to completion and finalization of essential and regulatory documents by the investigative site personnel.
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La Jolla Pharmaceutical Company (
TransPerfect, a leading provider of solutions for global development and commercialization of products to the life sciences industry, announced that Aptalis Pharma ("Aptalis") has implemented Trial Interactive as its global pharmacovigilance system master file (PSMF) solution.
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering small molecule drugs for hard to treat diseases, is pleased to update shareholders on the status of clinical trials for the Company's novel anti-cancer drug, Kevetrin™, at Harvard Cancer Center's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center.
A clinical trial to treat dengue fever with a new antiviral medicine, Celgosivir, has been initiated in Singapore. The trial follows successful mouse model studies by researchers at the Duke-National University of Singapore (NUS) Graduate Medical School, who established its efficacy (1). Celgosivir, also known as butyl-castanospermine, is derived from the seeds of the Moreton Bay Chestnut tree.
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to announce that the U.S. Food and Drug Administration ("FDA") has completed the review of the Company's Investigational New Drug (IND) application for Kevetrin™, the Cellcetix's novel anti-cancer compound, and has yesterday informed Cellceutix that "we have completed the review of your submission, and have concluded that you may proceed with the proposed study."
PRA, a leading Clinical Research Organization, announces that two of our experts will speak at the DIA 48th Annual Meeting being held in Philadelphia from 24-28 June.
TransPerfect, a leading provider of e-clinical technologies to the life sciences industry, recently announced that INC Research, a therapeutically focused clinical research organization (CRO), has selected Trial Interactive as its global electronic Trial Master File (eTMF) solution.
