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d-Wise Technologies can cost-effectively implement and integrate projects for your company.
d-Wise handles both systems implementation and integration.Many systems implementation projects today involve the integration of purchased, enterprise level software packages. Unless there is a unique competitive advantage, it is simply not cost-effective to develop your own corporate systems.hese projects are complex because they involve so many users, departments, locations and require buy-in from systems development, audit, and computer operations groups to name a few. They also involve many different activities that must be closely coordinated in order to get the software installed and functioning successfully. By using a technology expert like d-Wise to complete the implementation and integration of your project you can often realize cost-savingsover doing it yourself.
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In the pharmaceutical industry, gaps often exist between companies and internal working groups. Consider one of the industry’s largest players, ...
If you want disruptive innovation, seek disruptive innovators
In the spring of 2011, executives at J&J sat down to tackle a growing problem — inefficiencies in clinical trials. J&J created Clinical Trial Innovation a different group which had the 'luxury' to focus only on innovation while not being tasked with executing on the pipeline. This group was to develop solutions that would modernize clinical trials, improve data quality, and enhance the clinical trial process for patients and investigators. Having 13 new medicines approved in the last decade, J&J ranks at the pinnacle of the most productive pharmas, and perhaps is one of the most disruptively innovative.
d-Wise's clinical advisory services can help you identify the gaps between your current state and disruptive innovation.
Using an active surveillance pilot called Mini-Sentinel, the FDA has enlisted 18 major clinical partners to provide secure, de-identified patient data to examine massive quantities of information related to the effectiveness and safety of pharmaceuticals. The Agency is exploring a variety of approaches for improving the Agency’s ability to quickly identify and assess safety issues.
On 26 June, CDISC will continue its Members Only Mini-Training (formerly known as 'webinar') series with a presentation on: SDTM: What Data Managers Need to Know. Please fill in the registration details below to request access to this event. Confirmations will be sent out within a few days after your completed registration. Please contact email@example.com for inquiries on membership--otherwise contact firstname.lastname@example.org for all other inquiries.
The d-Wise Standards Implementation team will be on the call to hear what CDISC has to say about SDTM. We provide current data warehousing, systems development and integration, and CDISC standards expertise to establish or refine your conversion processes, including standard CRF development (CDASH/SDTM), CRF annotations, dataset (SDTM, SDTM+, and ADaM) and Define.xml specifications, and the development and validation of these outputs.
For late-stage implementation, d-Wise supports conversion services off of “legacy” data, as well as generation of integrated databases (ISS/ISE), creation or regeneration of TFL’s, and reconciliation against original CSR’s, all with a focus on regulatory compliance. http://www.d-wise.com/cdsdm-datasheet
Every IT organization struggles to balance strategic priorities with regulatory demands, but it's an especially burdensome task in healthcare. CIO Kristin Darby explains.
According to a survey at MIT’s Sloan CIO Symposium in Cambridge, Massachusetts, today's #1 challenge for CIO’s is grappling with the wave of new technologies available to them and putting the right tools and data in the hands of the right people and finding enough time to evaluate them correctly. http://www.d-wise.com/Default.aspx?app=bizblogger&tabid=1041995&subctrl=post&bid=345907&mid=2350982
JumpStart! - Modernizing the Drug Review Process read SelectScience news in the SelectScience scientific news archive
With the exponential increase in clinical trial data being submitted in a standardized format, the creation of this integrated review environment that partitions work enables data experts to really focus on data fitness and exploratory safety analyses. The FDA houses the largest repository of clinical trial data, when it is not in standard format it is more difficult to review. JumpStart runs a series of drug clinical trial data analyses within two weeks of the receipt of a new submission. The review process to assess data composition, quality, analyses options, and tools for the analyses, empowers reviewers to better understand the data and have the information to conduct an effective evaluation of the drug submission. Modernization is appearing in downstream processes like Jumpstart but also in upstream technology. d-Wise can help: http://www.prweb.com/releases/2014/06/prweb11910169.htm
Like other open CDISC data standards, the new MS standard is freely available (http://www.cdisc.org/therapeutic#MS). "This new tool is more than another resource for the MS research community," indicated Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer at the National MS Society. "This new MS standard signals a commitment to ensure that data does not remain in silos. By standardizing data we expect that research will move us faster toward our goal of a world free of MS."Read more: http://www.digitaljournal.com/pr/1962704#ixzz33gfurU3Y
The U.S. Food and Drug Administration today approved the CardioMEMSHF System that measures the pulmonary artery (PA) pressures and heart rates of patients with New York Heart Association (NYHA) Class III heart failure who have been hospitalized for heart failure in the previous year. The device allows health care professionals to monitor the condition of their patients remotely.
The FDA approved the first permanently implantable wireless device to monitor heart attack patients. who have been hospitalized for heart failure in the previous year. The device is intended to provide PA pressure measurements, including systolic, diastolic and mean PA pressures. In order to get approval, the company submitted data from its pivotal clinical study, and is requiring a thorough Post-Approval Study to continue to learn about the device’s performance when used outside the context of a clinical study.
Read the latest d-Wise blog posts, visit us online to read full articles and download them for free.
d-Wise’s Jack Shoemaker, VP of Healthcare Practice will be presenting “A Survey of Population Risk Management Applications Using SAS®” - The business of health insurance has always been to manage medical costs so that they don't exceed premium revenue. Shelley Dunn, d-Wise’s Senior Life Sciences Consultant will be presenting “How Valued is Value Level Metadata?”
AstraZeneca, Pfizer, Intermune, and Compugen could loom large in health care headlines this Monday morning. - Leo Sun - Health Care
Certainly, given the tax benefits available from moving to Great Britain from the U.S., AstraZeneca has the upper hand in any negotiations of a purchase price. Yet AstraZeneca shareholders clearly believe that there's no further room for negotiation, and the message they're sending the company today is that they'd prefer to take the best offer yet rather than rolling the dice and going it solo for the foreseeable future.
London (PRWEB) May 12, 2014 -- This October, PhUSE will celebrate its 10th anniversary at the annual conference that will be held in the Grange Tower Bridge Hotel in London. Conference chair Pierre Mayeur and his conference committee met their first target and managed to close the call for paper tool again on time with a new record breaking number of abstracts submitted.
This year PhUSE will celebrate it's 10th anniversary at the Annual event at the Grange Tower Bridge Hotel in London, October 12th to 15th. The theme of the event is Data Transparency and d-Wise will be there, sponsoring the Evening Gala Event. More than 185 abstracts for posters and presentations were submitted for the conference.
The recently published April CDISC newsletter
http://content.yudu.com/A2tq1h/April2014/resources/index.htm?referrerUrl= provides an update on the progress on the SHARE initiative. Also, expect a new website by summer that will host foundational standards, published machine-readable standards to eSHARE and a new prototype of their solution for research concepts.
For information on how they are using SOA's metadata repository to support SHARE, or to find out if SOA's Semantic Manager is for you get their FREE eBook: "Moving to a Standards-based, Agile Clinical Development Lifecycle" go to: http://www.d-wise.com/soa-whitepaper
CDISC has been actively collaborating with a variety of partners, including the Critical Path Institute, FDA, National Cancer Institute, other National Institutes of Health and TransCelerate Biopharma Inc. on the development of Therapeutic Area Data Standards. They just released the approved Therapeutic areas today and they include Alzheimer’s Disease, Asthma, Breast Cancer, COPD, CV Endpoints, CV Imaging, Diabetes, Hepatitis C, Influenza, Lipid-Lowering Drugs, Major Depressive Disorder (MDD), Multiple Sclerosis, Plaque Psoriasis [Ps], QT Studies, Rheumatoid Arthritis (RA), and Schizophrenia most propose the creation of User Guides, including concept maps, metadata, examples and controlled terminology.
This whitepaper presents a variety of perspectives on standards implementation, and technology implementation choices.
Is your company struggling with Technology Selection for a Clinical Data Repository, a Statistical Computing Environment or a Metadata Repository?
Many companies are considering the benefits of external help in guiding a company through the selection process:
Publishing genetic records on a block chain could help researchers design better drugs, while still maintaining patients' privacy.
This start-up company plans to store genetic and medical record data information using block chain technology making genetic data fully accessible to the researchers who need it, while using strong private keys to maintain digital DNA-wallet privacy and individual anonymity.
Last week d-Wise exhibited at the Drug Information Associations’ “DIA 2014” the organizations 50th Annual Meeting in San Diego, CA.
For most life sciences companies, existing tools and processes are already in place to accomplish the traditional tasks associated with data preparation, data delivery and analysis. And most companies also know that many of their existing tools and processes are dated and inefficient. Desperate to keep pace with their peers, or to respond to performance goals from senior management, organizations continue to invest in solutions that overpromise and underdeliver.http://www.d-wise.com/clinical-advisory-services-brochure
How today s life sciences companies are embracing a data unification strategy to become more data capable organizations
Does your organization have the data integration agility to overcome multiple data source hurdles facing life sciences today? Are you truly leveraging metadata within a modernized infrastructure that defines access and permissions while addressing governance challenges? d-Wise will help you face these and other challenges by leveraging extensive clinical domain expertise, proven collaborative methodologies and transformative solutions like semantics, cloud and self-service analytics and visualization. http://www.d-wise.com/systems-implementation
d-Wise launches Clinical Advisory and Modernization Services for Life Science ...Busbyway“d-Wise has recently completed clinical advisory assessments for both CRO and Sponsor clients with existing SAS infrastructures.
d-Wise's end-to-end consulting and assessment services encompass business process and change management; data and metadata-driven strategies; and vendor-agnostic infrastructure and technology assessment. We work with you to identify those business problems – systems, processes, architecture, etc. – that are inhibiting your ability to achieve your clinical research goals. And then we enable you to reach those goals by modernizing your software and solutions, business processes, and infrastructure.
API Access to Adverse Event Reporting System (FAERS), Real time data feeds...Transparency for All?
FDA released a beta version of OpenFDA http://open.fda.gov/ releasing more than 3 million reports on adverse drug events and medication errors recorded between 2004 and 2013. Before releasing the information the agency d-identified all patient identification and other sensitive information. It has also been formatted to let researchers, mobile applications and Web developers easily analyze the data and present it in a way that can help improve how people take drugs.The availability of this data also offers developers the ability to build their own applications on top of openFDA.
Pfizer Inc. said Monday that it had abandoned its current attempt to buy AstraZeneca PLC for nearly $118 billion — a deal watched warily by Maryland officials — as a deadline approached without a last-minute change of heart by the British drugmaker.
After a month long debate, Pfizer is walking away from a $118Billion dollar offer for AztraZeneca. A merger would have restored Pfizer as the world's largest drug manufacturer by sales, a position it relinquished to Swiss-based Novartis when billions of dollars in annual revenue evaporated after its top-selling cholesterol fighter Lipitor began facing generic competition in 2011.
Alarms raised about plans to limit access to clinical trials data
The Analysis Data Reviewer’s Guide Template, a creation of a PhUSE CSS working group with members from CDISC, the pharmaceutical industry and the FDA, is now available. The ADRG package provides an orientation to the submitted data in a consistent and usable format. | Virtual Strategy Magazine is an online publication devoted entirely to virtualization technologies.
FDA Reviewers benefit from additional, human-readable, documentation of analysis methods, datasets, and programs that cannot be fully explained within the ADaM metadata. To that end, PhUSE announced the availability of the Analysis Data Reviewer’s Guide (ADRG) package. The package contains templates, instructions, and examples to be used in submissions. Read more: http://www.virtual-strategy.com/2014/05/15/phuse-announces-analysis-data-reviewer%E2%80%99s-guide-work-package-finalization#ixzz32CCUUWdBRead more at http://www.virtual-strategy.com/2014/05/15/phuse-announces-analysis-data-reviewer%E2%80%99s-guide-work-package-finalization#zbUK0RuKw9HH2gpX.99
CDI provides a shared metadata environment that is both independent (for data integration) and part of SAS’ comprehensive platform.
In this example, reusable content is deployed as templates within SAS Clinical Data Integration, and it is these validated templates that result in the work reduction.. For example, using more traditional SAS programming to create the Demographics (DM) domain requires individually programming 26 variables. By using the validated template created within SAS Clinical Data Integration, only 4 variables need individual programming. Re-useable validated code already exists to create the other 22 variables. http://www.d-wise.com/sas-cdi/
An Interesting article on why implementing a cost efficient and seamless clinical supply chain is critical. Thirty-five percent of businesses recently surveyed by Gartner Inc. identified the inability to synchronize end-to-end business processes as an issue. The key success factor to streamline the collection and exchange of data is the development of secure e-platforms for capturing, gathering, consulting, sharing, and tracking all study data. The real added value, therefore, comes from the development of the e-platform best suited to support each clinical trial.
This datasheet presents our approach and understanding of the challenges to implement a successful clinical data standards governance program.
d-Wise's approach when implementing clinical data standards is iterative, building, evaluating, and improving the quality of the program with each iteration. Our proven methodology includes assessment, development of a strategy around the standards implementation, building CDISC and company-specific models, and addressing the often forgotten change management pieces. Download the Datasheet Now: