Webinar (May 18, 2017): Making Registries Into Reusable Platforms for Conducting Clinical Trials

 

The Clinical Trials Transformation Initiative (CTTI) is hosting a special webinar in which it will unveil new recommendations for registry assessment and design that can assist in making embedded clinical trials suitable for regulatory purposes. The presenters of the webinar will be:

 

John Laschinger, MD, Medical Officer, Center for Devices and Radiological Health, U.S. FDA, and

Jules Mitchel, MBA, PhD, President, Target Health Inc.

 

Here are the details:

 

Title: CTTI Recommendations from the Registry Trials Project
Date: May 18, 2017 12:00-1:00 p.m. ET (GMT-05:00)
Webinar Link: When it’s time, Join the Meeting

The webinar will include the following practical, evidence-based strategies:

 

How to assess the reliability, relevance, and robustness of registry data

How to assure patient protections

How to make modifications needed to accommodate research needs

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

New Publication on Risk-based Monitoring – Bravo to Vadim Tantsyura

 

Our esteemed data management expert and prolific writer, Vadim Tantsyura has done it again. The publication entitled “Risk-Based Approaches to Data Management and Data Quality: Double Standards or Is It Just Common Sense and Intelligence Taking Over?“ was recently published in Data Basics and co-authored with an international team from the US and Japan.

 

From the introduction: “At a recent Risk-based Monitoring (RBM) conference at University of Tokyo, the authors were asked “Do the various RBM approaches lead to double-standards in processes and quality?“ This report provides several examples when clinical data management (CDM) standard and a so-called best practices can, and perhaps should be deviated from – including such rarely questioned decisions involving database unlock, hard-coding or local laboratory ranges.“

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Annual DIA Meeting June 2017 – Mark Your Calendar

 

Target Health Inc. is very pleased to announce that it’s Content Hub proposal, entitled How eSource Solutions are Impacting Clinical Research Sites, Patients, Regulators and Drug and Device Companies has been accepted to the DIA 2017 Annual Meeting.

 

DIA is excited to be piloting this new event where attendees will have the opportunity to interact with community leaders and have one-on-one conversations to gain rapid insight in a subject of value; or attain a deeper perspective of a compelling session given earlier in the meeting.

 

The Content Hub presentation/conversation has been scheduled for:

Day: Tuesday

Date: 6/20/2017

Time: 4:00PM – 4:30PM

 

The Content Hub is designed for 30 minute short presentations and seating for an intimate audience of 30 people in a non-traditional session setting.  The Content Hub is informal with a mix of different styles of seating to encourage relaxed conversations between the audience and the leader.  A vital component of the Content Hub is the opportunity for the audience to participate in active Q&A.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Warren Pearlson Vacationed in Iceland and Wow!

 

Warren Pearlson, our esteemed Director of Business Development, visited Iceland recently and came back with some fantastic photos the he and a colleague took. Fortunately for Target Health, Dr. Mitchel will be presenting on the topic of EHR/EDC integration in Iceland in a few weeks at the Spring meeting of the eClinical Forum. Hope to see you there.

 

Iceland: Seljalandsfoss Waterfall (photo by Warren Pearlson

 

Iceland – Northern Lights (Photo by Tu Duong

 

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

BIOMED 2017 Conference – Tel-Aviv (May 23-25, 2017)

 

Target Health will again be attending the 16th MIXiii-BIOMED 2017 Conference and Exhibition, being held at the David Intercontinental, (May 23-25, 2017) in Tel-Aviv. This is the 16th anniversary of the conference which we have been attending since 2009. We have many clients and friends in Israel, so please let us know if you will be attending. We look forward to getting together and having a coffee.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

10 Steps to Consider to Fund and Provide Health Care for All

 

By Joyce Hays, MS and Jules Mitchel, MBA, PhD

 

Since we are all going to be a patient at multiple points in our lives, policy makers must support healthcare as a right rather than a choice. Therefore, from a strict business perspective, we must all pay for the right to have healthcare when we need it, and thus be part of the risk pool. It should not matter whether one is 1) working for a company that does or does not provide health insurance; 2) a sole practitioner; 3) unemployed; or 4) for whatever reason unable to work and pay premiums. The issue is, therefore, how to make healthcare universally available, and how to fund healthcare and health insurance premiums. While there are many more issues that must be addressed, here are 10 ideas that could make a difference right away:

  1. All citizens should have the same healthcare benefits provided to all members of congress who work for us. And that all American citizens, through their tax dollars, pay for the insurance that all of the congress enjoys.

 

  1. As taxpayers, we fund the critical research performed and supported by the National Institutes of Health (NIH), as well as other government agencies such as the Department of Defense (DoD). As a result, and as a return on our investment (ROI), a royalty from licenses/sales and any financial transactions related to any pharmaceuticals and devices that received funding from any government agency be allocated directly to healthcare services to all of our citizens.

 

  1. To encourage well educated US citizens, with good jobs that yield tax dollars, we should provide automatic paths to: work visas and to citizenship for any foreign college student graduating with a minimum of a B average, and for any graduate student receiving an advanced degree.

 

  1. As part of attending a medical school, tuition-free PLAN, all physicians must return to their solemn commitment and passion to assure that healthcare is available for those who need it, which is all of us.

 

To accomplish this, physicians should be required to provide services at public clinics in underserved geographical areas 1 day per week, on a salary basis, in return for the free medical school tuition. Additional salaries can be paid to those who want to commit more time to the public clinics, and additional insurance can be bought by patients who want “concierge” medicine, private rooms in hospitals, etc. When I was at Pfizer Pharmaceuticals, all licensed full-time physicians and pharmacists working at the company were allowed, on company time, to provide medical services one half day per week. The Pfizer Medical Director I worked for provided these services at a rheumatology clinic at Elmhurst Hospital in Queens, a city hospital. Similarly, many at Pfizer in Groton CT worked at Yale, Hartford Hospital, and Connecticut Children’s Medical Center at no cost to the institutions.

 

  1. The U.S. should open more medical school slots for future physicians which will allow for more staffing of the public clinics.

 

  1. The U.S. should encourage the use of telemedicine and remote medical devices to reduce patient travel for office visits.

 

  1. The U.S. should allow for more mobility by physicians across state line, all states respect medical and healthcare licenses issued by any other state.

 

  1. The U.S. should extend the patent life of life-saving drugs and devices.

 

  1. Health Insurance should be funded like term Life Insurance in that once the policy is bought, the premiums, which are paid for life, are also fixed for life. Therefore, the younger you are, the less expensive the premiums. Cash value may also accrue as the population becomes healthier.

 

  1. Climate change brings with it more virulent microbes. This is a new challenge to U.S. health agencies and to U.S. security. Common sense tells us that the healthier all Americans are, as a group, the greater chance to keep individuals healthy. When Americans as a group have access to healthcare, we, as a country are better able to handle pandemics, like the Zika virus, from becoming a nationwide disaster. This is the final reason to provide healthcare to all Americans and not just to a few.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

Conference: eSource Data in Clinical Investigations – May 2-3, 2017 – Doubletree Center City, Philadelphia, Pa

 

Target Health Inc. is pleased to announce that Dr. Jules Mitchel will be presenting at CBI’s 4th Annual Bootcamp on eSource Data in Clinical Investigations. The conference aims to initiate meaningful dialogues around early successes, failures and pain points through collaborative sessions and investigative case studies so that you can build an eSource adoption business case for senior leadership addressing balance of risk and cost.

 

Dr. Mitchel’s presentation is entitled: “The Future is Now: How to Obtain Stakeholder Buy-in and Initiate the Migration to eSource.” In this case study, you will learn how eSource reduced monitoring and increased overall data quality, as well as how to convince stakeholders to invest in eSource. You will also learn of the current challenges of interoperability between EHR and eSource and what the long-term strategy looks like in moving away from EDC as we know it today.

 

Please Mention Promo Code: NCE547 for a $500 discount when you register at the conference www.cbinet.com/esource.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

Conference: eSource Data in Clinical Investigations – May 2-3, 2017 – Doubletree Center City, Philadelphia, Pa

 

Target Health Inc. is pleased to announce that Dr. Jules Mitchel will be presenting at CBI’s 4th Annual Bootcamp on eSource Data in Clinical Investigations. The conference aims to initiate meaningful dialogues, through collaborative sessions and investigative case studies, around early successes, challenges and failures, so that one can build an eSource adoption business case for senior leadership addressing balance of risk and cost.

 

Dr. Mitchel’s presentation is entitled: “The Future is Now: How  to Obtain Stakeholder Buy-in and Initiate the Migration to eSource.” In this case study, you will learn how eSource reduced monitoring and increased overall data quality, as well as how to convince stakeholders to invest in eSource. You will also learn of the current challenges of interoperability between EHR and eSource and what the long-term strategy looks like in moving away from EDC as we know it today.

 

Please Mention Promo Code: NCE547 for a $500 discount when you register at the conference www.cbinet.com/esource.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Climate Change: Springtime in NYC: First a Snow Storm, then Sun and Flowers

 

The photo below was taken in the front gardens of our building in NYC showing the crocuses pushing through.

 

On this same morning we had a very cold snow storm, but by the time I was coming home in the afternoon, the sun was out and crocuses blooming.

 

First 2017 crocuses blooming in our front garden. © Joyce Hays, Target Health Inc.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

New Website Launched

 

Target Health Website has a new look, although the banner designed by CEO Joyce Hays, remains as well as the famous Leaping Dog, a feature of our website from inception. We are also very proud of our publications, many of which are prescient and trailblazing.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

← Previous PageNext Page →