Clinical trial op...
Follow
Find
5.4K views | +2 today
 
Scooped by d-Wise
onto Clinical trial optimization
Scoop.it!

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

more...
No comment yet.
Your new post is loading...
Scooped by d-Wise
Scoop.it!

Clinical Trial Data Transparency The Dangers Of “Putting It In Layman’s Terms”

Clinical Trial Data Transparency The Dangers Of “Putting It In Layman’s Terms” | Clinical trial optimization | Scoop.it
It’s been an exciting and tumultuous few months for ALS patients and the small biotech Genervon. The lengthening saga among the company, the...
d-Wise 's insight:

Real life example of data transparency and a position of: What good is transparency, if those who want to know how a drug candidate in development could help them are unable to grasp its benefits from a release jam-packed with highly technical, scientific data?

http://www.d-wise.com/blur


more...
No comment yet.
Scooped by d-Wise
Scoop.it!

AstraZeneca to Implement d-Wise De-identification Software

AstraZeneca to Implement d-Wise De-identification Software | Clinical trial optimization | Scoop.it
d-Wise de-id software - easily deployed through a browser, and incorporates clinical trials/healthcare de-identification rules and can be customized.
d-Wise 's insight:

This is a critical step in securing patient privacy across the biopharmaceutical industry’s data sharing initiatives.  As more and more biopharmaceutical companies participate in industry transparency activities, the ability to balance the desire to satisfy researchers with patient-level data while protecting patient confidentiality requires streamlining existing manual data de-identification processes with an automated software-driven approach. http://www.d-wise.com/clinical-de-identification


more...
No comment yet.
Scooped by d-Wise
Scoop.it!

SAS Grid Manager

SAS Grid Manager | Clinical trial optimization | Scoop.it
Get workload balancing, high-availability and faster processing in a flexible, centrally managed grid computing environment.
d-Wise 's insight:

For most organizations, SAS Grid is a new way to think about SAS, and it’s absolutely critical that the Grid implementation is done by technology experts that understand your clinical trials business.

d-Wise consultants are clinical trials experts and SAS technology experts. d-Wise was recently featured in a technology roundup in CIO Magazine entitled The 20 Most Promising SAS Solution Providers 2015. Our SAS Grid implementations are built to last, and optimized to meet the specialized needs of companies engaged in clinical research. http://www.d-wise.com/sas-grid


more...
No comment yet.
Scooped by d-Wise
Scoop.it!

Protect Patient Data With De-Identification

Protect Patient Data With De-Identification | Clinical trial optimization | Scoop.it
We need to continue working towards perfecting de-identification techniques and re-identification risk management frameworks, thereby ensuring that de-identification remains an essential tool in protecting privacy, both now, and well into the future.
d-Wise 's insight:

On the life science side of things, d-Wise continues to work on a clinical trial patient data de-identification software solution and develop effective techniques and re-identification risk management frameworks that provide patient privacy.http://www.d-wise.com/clinical-de-identification

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

Using SAS Macros and Scripts to De-Identify Clinical Trial Data? It’s time to restock the tool chest.

Using SAS Macros and Scripts to De-Identify Clinical Trial Data? It’s time to restock the tool chest. | Clinical trial optimization | Scoop.it
The d-Wise de-identification solution doesn’t fully automate the anonymization process because every trial is unique.
d-Wise 's insight:

The d-Wise de-identification solution doesn’t fully automate the anonymization process. Because every trial is unique, there must always be some industry knowledge to ensure that de-identification is being done correctly within the context of an individual trial. However, it’s no longer necessary to be dependent upon older tools that are challenging to learn and even more difficult to master. Instead, biopharmaceutical companies can benefit from a modern software solution that enables previously-completed de-identification projects to be rapidly applied to new projects – reducing costs, accelerating deliveries and producing high-quality de-identified clinical trial data.

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

Astellas Broadens Commitment to Clinical Trial Data Transparency

Astellas also recently revised and expanded its Global Policy on Clinical Trial Data Disclosure
d-Wise 's insight:

The company provided broadened access to anonymized patient-level data from interventional clinical trials in patients completed after January 2010 for products and indications that have been approved in the U.S. and/or in the E.U.  An initial list of Astellas studies available appears on clinicalstudydatarequest.com, which will be updated regularly. Astellas also recently revised and expanded its Global Policy on Clinical Trial Data Disclosure. d-Wise is currently developing a de-identification software product to support patient privacy for initiatives like this. http://www.d-wise.com/d-id


more...
No comment yet.
Scooped by d-Wise
Scoop.it!

FDA's CDER Unveils Ambitious 2015 Wish List - Quality Digest

FDA's CDER Unveils Ambitious 2015 Wish List - Quality Digest | Clinical trial optimization | Scoop.it
The folks at the Center for Drug Evaluation and Research (CDER) released their sometimes optimistic, but always enlightening guidance wish list and overall priorities for 2015. Let’s take a look.
d-Wise 's insight:

The FDA  wish list details many of the "front burner" initiatives for 2015. Interested in finding out more? d-Wise will be actively involved and exhibiting at the upcoming PhUSE CSS in Silver Springs. With over 35 posters (a dozen from FDA), discussions with FDA on the Guidance, a variety of Working Group topics, you should attend the 2015 PhUSE CSS in March! http://gag.gl/ZyMIQ4

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

CDR MDR Assessment | d-Wise.com

CDR MDR Assessment | d-Wise.com | Clinical trial optimization | Scoop.it
Visit d-Wise Technologies online today and learn how to choose the best metadata and clinical data repositories.
d-Wise 's insight:

With the emergence of data standards such as CDISC, the cost of leveraging clinical trial data continues to come down, at the same time that exciting clinical data visualization tools are coming to market. Life sciences companies are implementing Clinical Data Repositories (CDRs) to take advantage of this convergence as they explore aggregated data for both operational and scientific purposes. CDR solutions –some mature and some emerging –boast of rich capabilities and impressive returns-on-investment. Making the right technology choice can be difficult for life sciences companies as they wrestle with reputed challenges of older technologies and promises of newer offerings. d-Wise can help! With over 12 years of domain expertise we can support you all the way. http://www.d-wise.com/cdr-mdr-assessment-datasheet


more...
No comment yet.
Scooped by d-Wise
Scoop.it!

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.
more...
No comment yet.
Scooped by d-Wise
Scoop.it!

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. 

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

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!

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

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.”

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

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.

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

WHO calls for easy linking of bibliographic databases to trial registries

WHO calls for easy linking of bibliographic databases to trial registries | Clinical trial optimization | Scoop.it
The WHO's vision goes beyond the various trial transparency models adopted by drugmakers to date
d-Wise 's insight:

The WHO's vision goes beyond the trial transparency models adopted by drugmakers to date, citing the exclusion of results from old clinical trials as a major weakness in data disclosure initiatives, by stating that trial identifiers or registry codes must be used whenever information about a study is published.

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

CDISC Welcomes New Executive Director to CDISC Leadership – Press Release Rocket

CDISC Welcomes New Executive Director to CDISC Leadership – Press Release Rocket | Clinical trial optimization | Scoop.it
Dr. Nicole Harmon, Executive Director, to the CDISC leadership.
d-Wise 's insight:

d-Wise welcomes Dr. Nicole Harmon, Executive Director, to the CDISC leadership. As a platinum CDISC member and registered solution provider we wish Dr. Harmon the best.  d-Wise possesses a unique blend of experience within life sciences companies and extensive knowledge of  technology, processes and the value of CDISC standards. 

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

CTMS and eTMF: Leveraging Clinical Trial Data via Interoperable Systems

CTMS and eTMF: Leveraging Clinical Trial Data via Interoperable Systems | Clinical trial optimization | Scoop.it
A Preview of BioClinica's OnPoint CTMS and NextDocs eTMF Seems like change and complexity are the only constants in the clinical research world. We're continually dealing with something new − usually bringing with it added complexity − affecting how we do things in clinical trials.
d-Wise 's insight:

"On the technology end, massive propagation of eClinical applications has created many new eClinical product categories – most with overlapping functionality – yet without interoperability. Numerous new vendors continue popping up by the day next to established providers, each carrying its own unique data specification." At d-Wise we believe that the Life Sciences industry need not be that complex. We can help, by providing a technology neutral assessment. Visit us today www.d-wise.com


more...
No comment yet.
Scooped by d-Wise
Scoop.it!

Industry Timidity in the Latest European Debate on Trial Data Transparency

Under the terms of the new regulation, EMA is responsible for the development and maintenance of the portal and database foreseen for submitting clinical trial applications in the EU (while the authorization and oversight of clinical trials will remain with the member states). The portal and database will be the source of information to the public, in line with the regulation's provisions for transparency on the authorization, conduct, and results of clinical trial applications assessed, and on all clinical trials conducted in the EU. For each trial, the public will be able to access details including the major characteristics of the trial, the start and end of recruitment, end date of the trial and substantial modifications.

However, the regulation makes exceptions about access to the database for protection of personal data, protection of commercially confidential information (in particular in light of the marketing authorization status) "unless there is an overriding public interest", protection of confidential communication between member states as they prepare their assessment, and protection of the supervision of trials.
d-Wise 's insight:

Under the new regulation, EMA is responsible for the development and maintenance of the portal and database foreseen for submitting clinical trial applications in the EU (while the authorization and oversight of clinical trials will remain with the member states). The portal and database will be the source of information to the public, in line with the regulation's provisions for transparency on the authorization, conduct, and results of clinical trial applications assessed, and on all clinical trials conducted in the EU. For each trial, the public will be able to access details including the major characteristics of the trial, the start and end of recruitment, end date of the trial and substantial modifications.

However, the regulation makes exceptions about access to the database for protection of personal data, protection of commercially confidential information (in particular in light of the marketing authorization status) "unless there is an overriding public interest", protection of confidential communication between member states as they prepare their assessment, and protection of the supervision of trials. 

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

Clinical Trial Data: Shared Resource or Private Property? | The National Law Review

Clinical Trial Data: Shared Resource or Private Property?  | The National Law Review | Clinical trial optimization | Scoop.it
Sharing the results of expensive, time-consuming clinical trials is valuable, but it requires careful planning, proper oversight, and appropriate protection of patient privacy and commercial interests. Enhanced data-sharing with effective safeguards will assure that research is launched more quickly and effectively down the path toward scientific innovation in treating and curing debilitating diseases.
d-Wise 's insight:

One of the biggest risks around clinical trial data transparency and data sharing is participants’ privacy. Sharing the results of expensive, time-consuming clinical trials is extremely beneficial, but it requires careful planning, adequate de-identification and data security processes, governance, and the appropriate patient privacy protection. The continued growth in data-sharing with the proper safeguards in place will assure that clinical research is launched more quickly and effectively down the path toward scientific innovation and curing disease.

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

Call for transparency with clinical trial data

Call for transparency with clinical trial data | Clinical trial optimization | Scoop.it
The U.S. Institute of Medicine says results from human clinical trials ought to be made available to independent researchers within 18 months. This makes new drugs and their potential side-effects easier to evaluate.
d-Wise 's insight:

The Institute of Medicine has released a widely anticipated report that sets out several steps that clinical trial sponsors are encouraged to take in order to widen access to patient-level clinical trial data. As more and more companies investigate how best to participate in patient-level clinical trial data transparency initiatives, one thing is clear: Patient privacy and confidentiality must be protected. http://www.d-wise.com/d-id


more...
No comment yet.
Scooped by d-Wise
Scoop.it!

EMA seeks trial data transparency input

EMA seeks trial data transparency input | Clinical trial optimization | Scoop.it
The EMA is asking for comments on how to implement the transparency rules of EU Clinical Trial Regulation, pointing to the new clinical trial portal and database as the main instrument.
d-Wise 's insight:

The EMA is leading the way for clinical trial data transparency worldwide, and foremost is their concern to adhere to the highest standards of safety for participants. The European Clinical Trial Regulation is intended to transform the level of information publicly available for every clinical trial carried out in the EU – transparency on the authorization, conduct, and results of the trial will be obligatory. It also specifies a timeline for posting results no later than 12 months after a trial’s completion or 30 days after a Marketing Authorization Application (MAA) has been approved or withdrawn. De-identification of patient level data will be critical to patient privacy and data sharing among researchers and CRO's. http://www.d-wise.com/d-id


more...
No comment yet.
Scooped by d-Wise
Scoop.it!

Tufts CSDD 2014 Cost Study Claims cost to be 2.6 Billion up 145% from 2003

{my_page_description}
d-Wise 's insight:

Costs have been driven mainly by increases in out-of-pocket costs for individual drugs and higher failure rates for drugs tested in human subjects.

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

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. 

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

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,

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

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.

more...
No comment yet.
Scooped by d-Wise
Scoop.it!

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."

more...
No comment yet.

Modernize Today!!!

We won't put you in a lead nurturing program...we'll talk first!