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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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d-Wise Life Science’s Team Excels with 3 Top Presentations at PhUSE- London 2014

d-Wise Life Science’s Team Excels with 3 Top Presentations at PhUSE- London 2014 | Clinical trial optimization | Scoop.it
The Pharmaceutical Users Software Exchange (PhUSE) celebrated its 10th anniversary during their Annual Conference on 13 October in London.
d-Wise 's insight:
  • Ali Dootson, d-Wise Life Sciences Director, Europe won top honors with a presentation on, Agile Project Management in a Regulated Environment, where he identified the differences  between SCRUM development and Agile Development for a SAS Drug Development migration from version 3.5 to version 4.5.
  • Cathal Gallagher, a d-Wise Life Sciences Consultant based in the UK, won top honours with a presentation on, Reducing Programming Time with Reusable Templates, which demonstrated the value of using validated programming templates for CDISC transformations, a topic that also won top awards at the PhUSE FDA/CSS conference in the spring.
  • Ian Fleming, d-Wise Principal Life Sciences Consultant won top prize for his presentation on The Application of Directed Graphs to Clinical Development where he applied graph theory  which allows the dynamic linking of multiple concepts to clinical research.
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d-Wise Announces Upcoming Webinar on Modernizing Clinical Trial Infrastructure

d-Wise Announces Upcoming Webinar on Modernizing Clinical Trial Infrastructure | Clinical trial optimization | Scoop.it
(PRWEB) October 03, 2014 -- Learn how SAS Grid improves services to SAS users, improves performance and administration for IT, and why it is being adopted at biopharmaceutical companies and CROs worldwide.
d-Wise 's insight:

The webinar will take place on Tuesday, October 7, 2014 at 11:00 a.m. ET and will include a presentation by David Handelsman; d-Wise’s Senior Director of Industry Strategy and formerly SAS Institute’s recognized expert on clinical trials business issues. Dave is also currently the chair of the Clinical Data Interchange Standards Consortium (CDISC) Advisory Council. At d-Wise, Dave is heading up strategic initiatives around de-identification, clinical search and clinical advisory services The presentation will be followed by a 15-minute question-and-answer session. 

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SAS Programming – Don’t Settle for Less - Register for Our SAS Grid Webinar October 7

SAS Programming – Don’t Settle for Less - Register for Our SAS Grid Webinar October 7 | Clinical trial optimization | Scoop.it

SAS programming teams don't need productivity losses and wasted license costs due to obstacles in this era of critical deadlines and reduced budgets. d-Wise will be presenting a Webinar on October 7th entitled, “Modernizing Your Existing SAS Clinical Trials Environment with SAS Grid Manager” where we’ll give you the resources to decide if your organization will benefit by implementing SAS Grid. 

d-Wise 's insight:

So, why not Register today, and share this registration link below with your IT Group and SAS Administrators. (https://attendee.gotowebinar.com/register/4215153008593559809) Learn how SAS Grid can improve services to internal SAS customers – while making administration easier!

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d-Wise Leads the Way at the 10th Annual PhUSE Life Sciences Conference ... - Virtual-Strategy Magazine (press release)

d-Wise Leads the Way at the 10th Annual PhUSE Life Sciences Conference ... - Virtual-Strategy Magazine (press release) | Clinical trial optimization | Scoop.it
d-Wise Leads the Way at the 10th Annual PhUSE Life Sciences Conference ...
d-Wise 's insight:

“It’s fantastic to see how PhUSE has grown in 10 years,” said John Leveille, d-Wise CEO. “d-Wise has been an active supporter of PhUSE from its inception, and I’m thrilled we are attending the 10th anniversary event and sponsoring the Gala. d-Wise is actively involved with projects to protect patient confidentiality through de-identification in this new era of data transparency, and we're excited to be able to share our experiences at this event.”

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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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EMA opts for trial data transparency

EMA opts for trial data transparency | Clinical trial optimization | Scoop.it
Published journals frequently contain the outcomes of clinical trials but in the past, have lacked detailed information about the design, efficacy and safety analysis of the trials.
d-Wise 's insight:

Published journals often provide the outcomes of clinical trials but have not contained detailed information about the design, efficacy and safety analysis of the clinical trials. 

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It’s All about SAS/Base: Migrating from PC-SAS Towards a Modern SAS Infrastructure

It’s All about SAS/Base: Migrating from PC-SAS Towards a Modern SAS Infrastructure | Clinical trial optimization | Scoop.it
Clinical research companies continue to use the same SAS infrastructure they've used for the past 30+ years resulting in many maintenance nightmares.
d-Wise 's insight:

d-Wise, a global technology consulting company focused on the life sciences and healthcare industries, will be presenting a Webinar on October 7th entitled, “Modernizing Your Existing SAS Clinical Trials Environment with SAS Grid Manager” where we’ll give you the resources to decide if your organization will benefit by implementing SAS Grid. We’ll cover everything from what SAS GRID is, how you can migrate from your current SAS environment,

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Remote eTMF Access to Double in 2015, Reveals Industry-wide Survey - MarketWatch

Remote eTMF Access to Double in 2015, Reveals Industry-wide Survey - MarketWatch | Clinical trial optimization | Scoop.it
Remote eTMF Access to Double in 2015, Reveals Industry-wide Survey MarketWatch PLEASANTON, Calif., Sep 22, 2014 (BUSINESS WIRE) -- The life sciences industry's largest TMF survey to date reveals an increase in the number of clinical trial sponsors...
d-Wise 's insight:

In 2013, 33% of commercial sponsor inspections required extra days due to an incomplete TMF or lack of accessibility. Further, nearly 30% of inspectors in the U.K. refuse to use paper and, instead, require access to an eTMF, according to the Drug Information Association (DIA) 2014 TMF survey.

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d-Wise Recognized For Exemplary Workplace Practices - Virtual-Strategy Magazine (press release)

d-Wise Recognized For Exemplary Workplace Practices - Virtual-Strategy Magazine (press release) | Clinical trial optimization | Scoop.it
d-Wise Recognized For Exemplary Workplace Practices
Virtual-Strategy Magazine (press release)
That experience is rooted in extensive domain knowledge of SAS® software, clinical drug development and clinical data standards like CDISC.
d-Wise 's insight:

“We are extremely excited and proud as an organization to receive this recognition for our workplace practices,” said John Leveille, CEO and founder of d-Wise. "Our staff regularly expresses appreciation for the trust placed in them by d-Wise. They can see that our company policies and practices respect them as hard-working human beings who are striving to do their best work every day."

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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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