Pharmaceutical companies, CROs, and software/application vendors with operations in the European Union (EU) may be at serious risk from the new EU General Data Protection Regulation (GDPR). Violations of the regulation, which is set to go into effect in 2018, can result in penalties of €20 million or 4 percent of worldwide revenue.
Clinical News Roundup for the week of April 10, 2017 with information on Scott Gottlieb and adaptive approaches, preparing for epidemic clinical trials, proposed tax law changes for clinical research, and using selfies to improve medicine adherence.
Clinical news roundup for the week of April 1, 2017 with information on RBM and cost savings, a culture change around clinical data, proposed clinical research tax credits, increasing patient diversity, the pharma industry in Mexico, and patient trust and satisfaction.
As CEO for France-based biotech Onxeo, CEO Judith Greciet is always looking for new opportunities to bring complementary products on board to expand her company’s pipeline. Onxeo currently has three compounds in clinical development, with one at the end of its Phase 3 trial. “External development is a key path in our strategy to grow the company,” says Greciet. “Whether you refer to this as an acquisition or inlicensing, we knew we would require additional, innovative assets to widen our pipeline and increase the value of the company.”
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.
Fitness trackers were popular holiday gifts this year and sales are on the rise. While counting steps and getting fit may be the primary reason consumers are purchasing Fitbits and other wearables, other sensors these devices include, such as heart rate and sleep monitors, could actually help big pharma collect a wealth of valuable data to revolutionize personalized medicine.
If your organization has yet to adopt the use of eCOA (electronic clinical outcome assessments) in your clinical trials, then this white paper on successfully implementing the use of this technology should be of interest to you.
Several recent analyses have called attention to the increased scientific and operational complexity of today’s clinical trials.
PRA Health Sciences performed data management activities for this project while the client was responsible for all other services, including site monitoring. When the client reduced the timelines for database lock by approximately 9 months, PRA immediately created a detailed closure plan, listing all tasks and activities that required completion within the given timelines. This plan was reviewed and approved by all parties involved. To successfully complete the closeout period, PRA calculated data flows and trained additional staff members.
As technology solutions are increasing in adoption in the clinical research industry, ways to maximize their efficiencies are being more closely considered. eSource is emerging as a possible process to remove complexities and deliver time and cost savings to studies. By Niki Kutac, Director, Product Management, DATATRAK
With more than two decades of experience providing customized data management services for clinical trials to our clients, SynteractHCR is a contract research organization that has developed a reputation for high quality, cost effective solutions to fit your unique project needs. We know the importance of accurate, timely data management for clinical trials, and that’s why we have implemented the right combination of technologies with the care and insight of experienced personnel. Our clinical data managers have medical and life science backgrounds and as well as specialized programming experience.
SynteractHCR offers full-featured global Interactive Voice and Web Response Systems for your clinical trial operations, through our validated 21 CRF Part 11 compliant proprietary system. Once implemented, the system is available 24/7 for use by sites, study participants and project team members. Transactions are recorded into a study-specific database, and information can be exported into custom reports. Live technical support is available to sites and study participants via phone, email or web access. SynteractHCR has successfully implemented IWRS in 30 countries and has the capability to translate 26 different languages.
Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.
RAVE RTSM is the randomization and trial supply management (RTSM) application built within the Medidata platform to unify randomization, trial supply and EDC.
Our dedicated functional teams have the experience to be your partner in clinical research. We deliver a variety of clinical development services customized to fit your objectives, whether you need a single function across several drug programs, a range of functions within a single therapeutic area, a complete staff lift-out or any other defined need.
Trial Interactive is the all inclusive source for all of your clinical data management needs. In addition to hosting clinical trial solutions and electronic case site solutions, we also provide a full array of scanning and clinical document management services.
Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the completion of a method development project conducted in partnership with GlaxoSmithKline plc (GSK) to evaluate the impact of unifying mobile health (mHealth) devices with cloud-based technologies in a clinical trial setting. The joint initiative assessed the capabilities of mHealth tools and evaluated how they could be used to enable a new model for clinical trial conduct that aligns site and patient needs with faster study execution and reduced costs.
Medidata (NASDAQ: MDSO), a leading global provider of cloud-based solutions for clinical research in life sciences, and Pharmaceutical Product Development, LLC (PPD), a global contract research organization (CRO), today announced they are expanding their partnership to provide the life science industry with a more comprehensive approach to risk-based
monitoring (RBM)—aimed at conducting drug development more intelligently, more quickly and more cost-effectively.
Comprehend today announced it has secured $21 million in Series B financing to accelerate clinical development through its cloud-based business intelligence solutions, enabling life science companies to bring new treatments and devices to market faster and more affordably. The round was led by Lightspeed Venture Partners with support from existing investor Sequoia Capital. Lightspeed partner Peter Nieh joined the company’s board of directors.
Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that it is partnering with TransCelerate BioPharma Inc. ("TransCelerate") on a project designed to inform the nonprofit organization’s continued efforts to modernize and streamline the way clinical trials are conducted and monitored worldwide.
The finalists have been selected for the Society for Clinical Data Management’s Data Driven Innovation Award Program.
DATATRAK International, Inc. (OTCQX: DTRK), a leader in developing cloud-based, unified eClinical™ technologies and delivering related services for the clinical trials industry, today announced its operating results for the fourth quarter and full year of 2012.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that NorthWise Services (NWS) has partnered with Merge and selected eClinical OS™ to collect, manage and report on clinical trials data across all studies.
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.
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.
PSI CRO, a full-service Contract Research Organization, known for its time and money saving ability, by offering pharmaceutical sponsors delivery of clinical trials on-schedule and on-budget, announces recently successful expansion of its clinical data management services.
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.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that NCGS Incorporated has selected Merge’s eClinical OS™ and clinical trial management (CTMS) solution to streamline data management activity through electronic data capture (EDC) technology transfer and improve study management efficiency.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that Datapharm Australia Pty Ltd. has selected Merge’s eClinical OS™ solution to bring EDC in-house and provide control of electronic case report form (eCRF) creation and mid-study adjustments.
DaVita Clinical Research (DCR), a provider of clinical research services focused on kidney research as well as a multitude of specialty therapeutic populations, has hired four individuals to ignite the expansion of DCR at its latest clinical research facility in Denver, Colo., scheduled to open this month.
