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Remote Patient Monitoring will Lead Value-Based Healthcare | The ...

Remote Patient Monitoring will Lead Value-Based Healthcare | The ... | Clinical trial optimization | Scoop.it

Traditional health insurance reimbursement to providers (though payment is a more appropriate word) for healthcare services and products is at the root of our healthcare crisis.  Our traditional fee for service system in the USA rewards hospitals and providers for doing more (and more costly) procedures to patients. Some interesting findings from a study from Harvard Medical School  were that the higher the cost of surgery, the greater the likelihood of complications and the more out-of-pocket a patient with Medicare or private insurance paid, the more complications were reported. In addition, if a patient paid for the surgery fully out-of-pocket or through government-funded Medicaid, the likelihood of complications was lower. The Affordable Care Act, which introduces newer payment models including bundled payments, is creating an economic environment which is conducive to the widespread use of remote patient monitoring (RPM) for recently discharged hospital patients and those with chronic diseases. RPM will be most focused on vital signs monitoring for cardiac and pulmonary patients and diabetes monitoring.  Larger opportunities abound for weight management, medication adherence, and preventive medicine.

Recent institution of Medicare payment penalties for hospital readmissions is probably the most immediate impetus for the interest by healthcare systems in RPM. Studies at Johns Hopkins University and Geisinger Medical Center are just a few which demonstrate this utility of RPM.

RPM, will, in addition, foster other offshoot benefits of its technology. Firstly, I believe it will accelerate interoperability of disparate digital monitoring technologies, EHRs and patient portals. The ability of different technologies to talk to each other and to EHRs is at the heart of potential benefits of electronic health data.  Secondly, it will change the culture of healthcare to shift the focus from the provider to the patient. Data emanating from patients will de facto involve patients more than they are now in their own care. Seeing the data will educate them and facilitate self-management (to detractors of the concept of self-management, patients have been self-managing diabetes for decades). RPM will increase interest in (and hopefully use of) patient portals which will be mobile hubs of patient health records and communication. But I digress (something I usually don’t do, but RPM has so many ramifications).  This will also herald an introduction into the use of mobile apps by patients, recommended by providers. The issue surrounding reimbursement for health apps in general will also be resolved as it follows the path of RPM.

Organizations adopting RPM now are those who already have value-based or bundled payment systems or who realize that determining the ROI of technology in healthcare can be complex and that the predictable prevention of penalties is a good starting place. Improving longer term outcomes of RPM certainly needs more study.

While RPM is not new, its place as a leader of technology in the new payment system healthcare space is. RPM is well-suited for bundled payment systems because it is not just a technology. It involves the creation of processes and changes in workflow around the technology, some of which are home-based and some office and hospital-based. The success of RPM depends upon physician champions who will design these processes, and devise alert self-management, provider notification and treatment algorithms. RPM, via technology, can be the door to better provider-patient communication, more meaningful office follow-up visits, and increased caregiver participation.  Nothing I’ve said here is earth shattering news. I meant to bring the discussion of RPM to a practical level about why it is here, needs to be utilized now and where it fits in to existing strategies. Let’s all welcome it.

 

 


Via Gilles Jourquin, dbtmobile
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Clinical trial optimization

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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

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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.
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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
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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
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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.
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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.

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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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CDISC-April 2014-SHARE UPDATE

CDISC-April 2014-SHARE UPDATE | Clinical trial optimization | Scoop.it
 
d-Wise 's insight:

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

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CDISC Therapeutic Area Data Standards

CDISC Therapeutic Area Data Standards | Clinical trial optimization | Scoop.it
d-Wise 's insight:

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.

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Data, Metadata Process Optimization Whitepaper | d-Wise.com

Data, Metadata Process Optimization Whitepaper | d-Wise.com | Clinical trial optimization | Scoop.it
This whitepaper presents a variety of perspectives on standards implementation, and technology implementation choices.
d-Wise 's insight:

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:

 

  • Review the business case and opportunities to follow best practice
  • Allows You to Focus on Core BusinessReduced  Time‐to‐Decision
  • Resource savings on Vendor Search, Due Diligence, Project ManagementCompletely eliminate the time‐consuming RFI process
  • Leverage real world implementation experience across a range of technologies
  • Utilize our proven decision framework and methodology
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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.
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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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Creating CDISC SDTM and ADaM Tables in Less than 10% of the Time

Creating CDISC SDTM  and ADaM Tables in Less than 10% of the Time | Clinical trial optimization | Scoop.it
CDI provides a shared metadata environment that is both independent (for data integration) and part of SAS’ comprehensive platform.
d-Wise 's insight:

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/

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eGSP: Operational Approach for Optimization of Clinical Trial Supplies Through Integrated e-Platforms - Applied Clinical Trials

eGSP: Operational Approach for Optimization of Clinical Trial Supplies Through Integrated e-Platforms - Applied Clinical Trials | Clinical trial optimization | Scoop.it
d-Wise 's insight:

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.

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CDSDM Datasheet

CDSDM Datasheet | Clinical trial optimization | Scoop.it
This datasheet presents our approach and understanding of the challenges to implement a successful clinical data standards governance program.
d-Wise 's insight:

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:

http://www.d-wise.com/cdsdm-datasheet/


 

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