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Standards Implementation | d-Wise Technologies, Inc

Standards Implementation | d-Wise Technologies, Inc | Clinical trial optimization | Scoop.it

"Implementing compliant data standards and governance has become Job 1 in in clinical research"

d-Wise 's insight:

d-Wise has a unique combination of clinical research experience and technology expertise including delivering SAS solutions within Life Sciences, clinical data management, programming, analytics, and FDA submissions. We also have extensive knowledge of CDISC, HL7 and other industry standards

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Clinical trial optimization

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Big Data Peeps At Your Medical Records To Find Drug Problems

Big Data Peeps At Your Medical Records To Find Drug Problems | Clinical trial optimization | Scoop.it
It's been tough to identify the problems that only turn up after medicines are on the market. An experimental project is now combing through data to get earlier, more accurate warnings.
d-Wise 's insight:

Mini-Sentinel was a $116 million government project to actively go out and look for adverse events linked to marketed drugs. It has been an experiment to see what's possible, but its contract ends in September and the FDA will be deciding what to do next. Problem has been, almost all of that data comes from billing records (codes for any diagnostic tests and procedures you undergo) not physician input. Billing data were never meant to be used this way because things may change depending on what claims data set you use, or how you run your definitions, or how you set up your parameters and so forth. So far, all the money for this particular project has come from pharmaceutical companies like Merck, Pfizer, Novartis, Johnson & Johnson, GlaxoSmithKline, AstraZeneca and Eli Lilly.

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R: The most powerful and most widely used statistical software

In the last ten years, the open source R statistics language has exploded in popularity and functionality, emerging as the data scientist's tool of choice. T...
d-Wise 's insight:

R is a language and environment for statistical computing and graphics. R, like S, is designed around a true computer language, and it allows users to add additional functionality by defining new functions. Much of the system is itself written in the R dialect of S, which makes it easy for users to follow the algorithmic choices made. For computationally-intensive tasks, C, C++ and Fortran code can be linked and called at run time. Advanced users can write C code to manipulate R objects directly. R provides a wide variety of statistical (linear and nonlinear modelling, classical statistical tests, time-series analysis, classification, clustering, ...) and graphical techniques, and is highly extensible. 

Production statistical computing environments must be validated and compliant; no exceptions. With limited resources, minimal QA, and  IT staff, it is difficult to know how to proceed.

Download d-Wise's case study on building a hosted Statistical Computing Environment 

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The Era Of Big Data And Its Implications For Big Pharma

The Era Of Big Data And Its Implications For Big Pharma | Clinical trial optimization | Scoop.it
Health Affairs is the leading peer-reviewed journal at the intersection of health, health care, and policy.
d-Wise 's insight:

Do you know the difference between clinical trial data and other real world data? In Life Sciences trial data is collected for the specific purpose of obtaining regulatory approval for a new medicine, or a new indication for a medicine. They are focused on specific patient populations, and take significant time, effort and money to complete. Real world data, or basically everything else, has fewer regulations around how the analyses are designed, executed and disseminated. This article describes many of the issues involved with leveraging this data from data ownership to data liberation, EHR Implementation and private and public sector collaboration. 

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JJ’s Approach To Capturing Disruptive Innovation In Clinical Trials

JJ’s Approach To Capturing Disruptive Innovation In Clinical Trials | Clinical trial optimization | Scoop.it
In the pharmaceutical industry, gaps often exist between companies and internal working groups. Consider one of the industry’s largest players, ...
d-Wise 's insight:

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.

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FDA teams with 18 Clinical Partners to use EHR data analytics in Mini-Sentinel Project

d-Wise 's insight:

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.

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CDISC Members Only Mini-Training Series: SDTM: What Data Managers Need to Know

CDISC Members Only Mini-Training Series: SDTM: What Data Managers Need to Know | Clinical trial optimization | Scoop.it
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 membership@cdisc.org for inquiries on membership--otherwise contact training@cdisc.org for all other inquiries.
d-Wise 's insight:

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


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Balancing strategic priorities with all things regulatory - Top CIOs reveal their biggest information technology issues

Balancing strategic priorities with all things regulatory - Top CIOs reveal their biggest information technology issues | Clinical trial optimization | Scoop.it
Every IT organization struggles to balance strategic priorities with regulatory demands, but it's an especially burdensome task in healthcare. CIO Kristin Darby explains.
d-Wise 's insight:

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


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JumpStart! - Modernizing the Drug Review ProcessSelectScience

JumpStart! - Modernizing the Drug Review ProcessSelectScience | Clinical trial optimization | Scoop.it
JumpStart! - Modernizing the Drug Review Process read SelectScience news in the SelectScience scientific news archive
d-Wise 's insight:

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

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CDISC Data Standard for Multiple Sclerosis Spurs Sharing of Clinical Data

CDISC Data Standard for Multiple Sclerosis Spurs Sharing of Clinical Data | Clinical trial optimization | Scoop.it
>PRWEB.COM Newswire
d-Wise 's insight:

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

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FDA approves first implantable wireless device with remote monitoring to safeguard heart attack patients.

FDA approves first implantable wireless device with remote monitoring to safeguard heart attack patients. | Clinical trial optimization | Scoop.it
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.
d-Wise 's insight:

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.

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Clinical Trial Optimization | d-Wise.com

Read the latest d-Wise blog posts, visit us online to read full articles and download them for free.

d-Wise 's insight:

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?”

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Monday’s Top Health Care Stories: AstraZeneca, Pfizer, Intermune, and Compugen (AZN, CGEN, ITMN, PFE)

Monday’s Top Health Care Stories: AstraZeneca, Pfizer, Intermune, and Compugen (AZN, CGEN, ITMN, PFE) | Clinical trial optimization | Scoop.it
AstraZeneca, Pfizer, Intermune, and Compugen could loom large in health care headlines this Monday morning. - Leo Sun - Health Care
d-Wise 's insight:

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.

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PhUSE on Track to Beat All Records for Its 10th Anniversary Annual Conference

PhUSE on Track to Beat All Records for Its 10th Anniversary Annual Conference | Clinical trial optimization | Scoop.it
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.
d-Wise 's insight:

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 EventMore than 185 abstracts for posters and presentations were submitted for the conference.

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FDA Adds Recall Information to Open Access Data Initiative - iHealthBeat

FDA Adds Recall Information to Open Access Data Initiative - iHealthBeat | Clinical trial optimization | Scoop.it
FDA has expanded its open access data platform to include an Application Programming Interface that allows developers, researchers and other users to access reports on adverse drug events and medication recalls submitted to the agency's database since 2004. Health Data Management, FDA's "FDA Voice."
d-Wise 's insight:

The FDA is now offering an API as part of Open FDA that gives users access to a recall database of several million reports on adverse drug events and medication errors received by the FDA since 2004, and is the second dataset to be included in the OpenFDA initiative.

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Modernization as a Mindset for Clinical Trials: Your Key to Addressing Smaller Budgets, Reducing Frustration, and Increasing Efficiency

Modernization as a Mindset for Clinical Trials: Your Key to Addressing Smaller Budgets, Reducing Frustration, and Increasing Efficiency | Clinical trial optimization | Scoop.it
Are you and your co-workers frustrated by older technology and processes, yet somewhat resistant to updates that require an investment of time, resources and learning?
d-Wise 's insight:

CIMI Corporation is a full-service consulting firm that provides strategic product, service, market, and positioning guidance to service providers, equipment/software vendors, and select enterprises. The company blends research,surveys and computer modeling of buyer/market behavior to create a true market model.


According to a 2013 survey, 1/3 of businesses run major applications more than 10 years old and 1/5 have at least one major application that's largely gone unchanged for 15 years or more.


While modernizing solutions and processes require investments of time, resources and budget, wise investments result in reduced total costs, higher quality results and flexible approaches to future modernization activities.

d-Wise Clinical Advisory and Modernization Services will enable you to adopt a progressive and comprehensive approach to modernizing your clinical trial solutions and processes. Our 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.

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Fundamental Ways We Use Data Visualizations

The fundamental ways we use data visualizations effectively (with examples).
d-Wise 's insight:

Interesting statistics on how our brains are wired for visualization as opposed to reading. Without visualization, we depend on numbers, which most often represent summaries or aggregations, statistics, or other computed results. These can hint at structure in the data but are often too precise to show related structures. Currently, the trends in Life Sciences and Healthcare around visualization are 1.) a stronger relationship between analysis & reporting and visualization. 2.) the use of larger data 3.)  Use of algorithms and visualizations in parallel 4.) the pre-processing of large data sets prior to use of visualization tools. d-Wise can help get you started on the right foundation for anlytics and the use of visualization tools: http://www.d-wise.com/health-data-services


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DNA Block Chain Project Boosts Research, Preserves Patient Anonimity

DNA Block Chain Project Boosts Research, Preserves Patient Anonimity | Clinical trial optimization | Scoop.it
Publishing genetic records on a block chain could help researchers design better drugs, while still maintaining patients' privacy.
d-Wise 's insight:

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.

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d-Wise Fosters Innovation through Clinical Advisory Services and Modernization

d-Wise Fosters Innovation through Clinical Advisory Services and Modernization | Clinical trial optimization | Scoop.it
Last week d-Wise exhibited at the Drug Information Associations’ “DIA 2014” the organizations 50th Annual Meeting in San Diego, CA.
d-Wise 's insight:

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


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The Analytic Trifecta: Abstraction, the Cloud and Visualization

The Analytic Trifecta: Abstraction, the Cloud and Visualization | Clinical trial optimization | Scoop.it
How today s life sciences companies are embracing a data unification strategy to become more data capable organizations
d-Wise 's insight:

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


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d-Wise launches Clinical Advisory and Modernization Services for Life Science ... - Busbyway

d-Wise launches Clinical Advisory and Modernization Services for Life Science ... - Busbyway | Clinical trial optimization | Scoop.it
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 insight:

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.

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openFDA-a beta research project but not for clinical use

openFDA-a beta research project but not for clinical use | Clinical trial optimization | Scoop.it

API Access to Adverse Event Reporting System (FAERS), Real time data feeds...Transparency for All?

d-Wise 's insight:

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.

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Life as a Healthcare CIO: Apple Enters the Healthcare Software Ecosystem

Life as a Healthcare CIO: Apple Enters the Healthcare Software Ecosystem | Clinical trial optimization | Scoop.it
d-Wise 's insight:
Apple Enters the Healthcare – with Health app but more importantly with technology development in mind, enter HealthKit – provides for  a “common platform” (sound familiar? http://www.d-wise.com/enterprise-data-warehouses/) internally for health apps allowing for common data formats, data exchange, storage and presentation to the patient; Apple again is establishing an ecosystem here. Having centralized support for healthcare data, makes applications more interoperable and useful.
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Pfizer walks away from AstraZeneca takeover attempt

Pfizer walks away from AstraZeneca takeover attempt | Clinical trial optimization | Scoop.it
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.
d-Wise 's insight:

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. 

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Researchers Slam Transparency 'U-Turn' at E.U. Medicines Agency

Researchers Slam Transparency 'U-Turn' at E.U. Medicines Agency | Clinical trial optimization | Scoop.it
Alarms raised about plans to limit access to clinical trials data
d-Wise 's insight:

Europe has been leading the clinical trial transparency bandwagon and promised to be more transparent in 2010. In 2012 they launched a system to publish full clinical trial datasets with a target date of January 2014 for release. Now in a draft “terms of use document”, they are backpedalling and saying that registered users would only be allowed to view trial information on screen, making it more difficult to reanalyze data. They would not be permitted to “download, save, edit, photograph, print, distribute or transfer the information.”

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Analysis Data Reviewer’s Guide Work Package now Available

Analysis Data Reviewer’s Guide Work Package now Available | Clinical trial optimization | Scoop.it
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.
d-Wise 's insight:

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#ixzz32CCUUWdB

Read more at http://www.virtual-strategy.com/2014/05/15/phuse-announces-analysis-data-reviewer%E2%80%99s-guide-work-package-finalization#zbUK0RuKw9HH2gpX.99

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