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d-Wise, Inc.
32 followers -
Data and Process optimization services for Life Sciences and Healthcare.
Data and Process optimization services for Life Sciences and Healthcare.

32 followers
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As part of a general trend to improve transparency and data sharing in life sciences, the European Medicines Agency now requires that clinical study reports (CSRs) are published publicly.

This has placed new pressures on companies to protect patient privacy – by ensuring they cannot be identified from reports entering the public domain. Under EMA Policy 0070, CSRs must be anonymized to prevent patients (and indeed professionals) who participated in clinical trials from being identified.

But what is clinical trial de-identification? And why is it imperative to have your data de-identified?

Read the full article here: https://hubs.ly/H0c9wMk0
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EMA Data Transparency Regulation Upheld in Court

“The EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies filed to suspend the release in 2016. The court rejected claims by Pari Pharma, PTC Therapeutics, and MSD Animal Health Innovation and Intervet, explaining the companies failed to…"

Read the entire post here: https://hubs.ly/H0byj0p0
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Attention all medical writers!

Join d-Wise at the 46th EMWA Conference in Barcelona, Spain May 1-5, 2018.
Professional development and networking for medical writers at all stages in their careers. Including 52 EPDP training workshops covering a wide range of medical writing topics, 8 expert seminars, and much more.

Register here: https://hubs.ly/H0byhJl0
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The 2018 Blue Cross and Blue Shield National Summit is quickly approaching! The conference will take place on May 1st – May 4th in Orlando, FL.

d-Wise will be at booth 835. We will be demonstrating our healthcare data & analytics solutions like Provider Sphere, RADAR, Valuation, Trend, Provider Predictive Modeling and our Data & Analytics Blueprint Methodology.

Connect with us today: https://hubs.ly/H0bHxth0
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Join d-Wise at PharmaSUG 2018! April 29 - May 2 | Seattle, Washington

PharmaSUG is the premier event of the year for statistical programmers, statisticians, data managers, researchers, and others who analyze data in the life sciences. If you are looking for practical, real-world knowledge, you won't want to miss PharmaSUG 2018.

Register for the conference now! https://hubs.ly/H0byg5B0
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Join d-Wise at the 2018 CDISC Europe Interchange April 23 -27 in Berlin, Germany.

Hear presentations and panel discussions from visionaries, thought leaders, and global regulatory representatives on the latest trends and initiatives in clinical research. Participate in hands-on workshops geared toward practical application of CDISC Standards.

Register here! https://hubs.ly/H0byhFv0
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Supporting Innovations in Global Health

"A $3 birthing kit created by an entrepreneur in India. A Health tool that enables health workers to accurately and rapidly diagnose common illnesses in rural Liberia. A chain of primary health clinics in rural Kenya that employ a community-ownership model.
These are just a few of the unique healthcare approaches being supported by the Pfizer Foundation1 through its Global Health Innovations Grants (GHIG) program."

Read the full story: https://hubs.ly/H0bygsk0
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"This guidance focuses on the FDA’s policy for refusing to file an NDA under § 314.101 when the NDA is incomplete because it does not on its face contain information required under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 314.50."

The draft guidance emphasizes the importance of agreements between the FDA and sponsor "regarding the content of a complete application...” d-Wise believes this includes agreements such as the Study Data Standardization Plan (SDSP).

Read the full article here: https://hubs.ly/H0bygdS0
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Beam your customers into invisibility: A data protection masked ball to get you up to speed with the GDPR

"Here are some new tips for masking. The new EU General Data Protection Regulation (GDPR) requires your company to implement (quote) all necessary technical and organizational measures and to take into consideration the available technology at the time of the processing and technological developments. So, how can you comply with this requirement in the real world?"

Read the full post here: https://hubs.ly/H0bygc50
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Under EMA Policy 0070, CSRs must be anonymized to prevent patients (and indeed professionals) who participated in clinical trials from being identified. But what is clinical trial de-identification?

Clinical trial de-identification refers to the process of eliminating reasonable risk of individual patients from being identified from references made in external reporting of clinical trial findings.

If companies do not take sufficient measures to protect patient privacy as their clinical trial findings are published externally, they risk serious consequences. As well as undermining patient trust and damaging the organization’s reputation, firms risk being fined heavily for privacy breaches.

Read the full article here: https://hubs.ly/H0bygbg0
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