Leading Edge CDM Solutions

The 7.1 magnitude earthquake that rocked Southern California made me concerned about our adorable adopted from ASPCA schnauzer: what would happen if the earthquake hits Northen CA?

A quick googling immediately produced tons of information but one article attracted my particular attention. Working in clinical research I was pleased that FDA cares about all live creatures (yes, humans are included). Sharing their suggestions here...: https://www.fda.gov/animal-veterinary/animal-health-literacy/take-care-your-pets-disaster-strikes.

http://go.medrio.com/The-Evolution-of-Data-Management_Webinar-LP-ODW.html

Use of Electronic Health Record Data in Clinical Investigations
Guidance for Industry
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)

Use of Electronic Health Record Data in Clinical Investigations
Guidance for Industry
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA office
responsible for this guidance as listed on the title page.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf?utm_campaign=SBIA%3A%20New%20Guidances%3A%20Use%20of%20Electronic%20Heal...

Press Announcements > FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes

The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.

“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” said FDA Commissioner Scott Gottlieb, M.D. “These technologies allow patients to gain better control over their health. This approval of a more seamless digital system that gives patients the ability to effectively manage a chronic disease like diabetes is a vivid illustration of the potential for these mobile platforms. The FDA is creating a new and more carefully tailored regulatory approachfor software products,...

Press Announcements > FDA approves first artificial iris

The U.S. Food and Drug Administration today approved the first stand-alone prosthetic iris in the United States, a surgically implanted device to treat adults and children whose iris (the colored part of the eye around the pupil) is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye.

“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. “Today’s approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.”

Congenital aniridia is a rare genetic disorder in which the iris is completely or partially abse...

...CROs and Sponsors are both investing heavily in new capabilities to better integrate and analyze the ever-increasing volume of data that plays a role within and around the execution of clinical trials. ...

Transforming Clinical Ops with Technology Standards

Open technology standards aim to simplify trial execution and improve efficiency and productivity of clinical trials

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Kristin Brooks, Contract Pharma

Real world evidence and virtual trials are playing a much larger role in drug development today. Both generate vast amounts of data and the availability and cost of acquiring data remain key challenges. As a result, large pharma, biopharma, and CROs plan to increase internal staff dedicated to collection and analysis of real world...

Great (free) FDA conference at Hyatt Regency in Burlingame, CA on May 15, 16! It was targeted at small drug & device companies and had tons of useful information. Here are the recordings if you didn't have a chance to attend. If your company deals with devices I recommend to download a "ZIP of DEVICES Track slides" and start with the article DEV-D1SO6-Choi.

http://sbiaevents.com/redi-conference-2018/

Here's how Amazon Alexa will work with Microsoft Cortana

By Pete Pachal

We just got our first taste of how digital assistants will talk to each other.

At its Build 2018 developers conference, Microsoft showed how its AI assistant, Cortana, will interact with Amazon Alexa, assuming you use both. Since many use Alexa at home but Microsoft products at work, an integration would be a bridge between personal conveniences like ordering Ubers or playing music and task-oriented needs like calendars and business communication. 

This is a major first step toward voice-controlled systems interacting with one another, with one filling in where the other comes short. Companies like Apple may allow their digital assistants to interact with specific services — ask Siri to show you the best-reviewed restaurant nearby and it will display a list with star ratings from Yelp and OpenTable — but this pairing appears to go deeper.

In an onstage demo, Megan Saunders, Microsoft's general manger of Cortana, began t...

What Are the Different Types of Clinical Research?

Different types of clinical research are used depending on what the researchers are studying. Below are descriptions of some different kinds of clinical research.

Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy. 

Prevention Research looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes. 

Diagnostic Research refers to the practice of looking for better ways to identify a particular disorder or condition. 

Screening Research aims to find the best ways to detect certain disorders or health conditions. 

Quality of Life Research explores ways to improve comfort and the quality of life for individuals with a chronic illness. 

Genetic studies aim to improve the prediction of disorders by id...

Will CDISC Demo Drive Demand for EDC/EHR Integration?

Four major pharmaceutical companies and a California systems integration services firm are providing the "brain and brawn" -- as well as the funding – to demonstrate the feasibility of integrating data capture needs of clinical research and disease prevention with electronic health records (EHRs), says Tanyss Mason, director of communications for the Clinical Data Interchange Standards Consortium (CDISC). At present, "it's not unusual for [investigative] sites to have an EHR as well as multiple EDC [electronic data capture] tools, and it's unwieldy."

CDISC, which is spearheading the demonstration project, views data capture as a "single-source encounter between an investigator/physician and subject/patient," says Landen Bain, CDISC liaison to healthcare. The "key idea" is to have a data-capture form appear on the computer screen in an EHR session. "If you have an EHR, it's contorted to go to a different computer and a different...