Judy Schloss Markowitz is Now a Retiree

 

From the desk of Dave Luke, PharmD, Sr. Director, Clinical and Scientific Affairs at Target Health Inc.

 

Target Health Inc. is announcing the retirement of a longtime colleague, Judith (Judy) Schloss Markowitz. Judy is a first generation American whose mother, Ruth, is a Holocaust survivor, and her father immigrated from Germany to the US when he was 2 years of age. A true New Yorker from Queens, with an accent and attitude to prove it, Judy graduated with a Master’s degree in Education from Queens College, CUNY.

 

Judy joined PhRMA as a clinical monitor at Ives Laboratories – which was then a division of American Home Products (AHP). She then watched the industry merge over her 32 year career from AHP to Ayerst Laboratories, to Wyeth-Ayerst, to Wyeth and finally to Pfizer. Judy joined Target Health as Senior Clinical Project Manager in 2010.

 

I had the privilege of meeting Judy 18 months ago when I joined Target Health. Judy helped me onboard and we worked very closely on many time-critical projects. I depended on Judy as a very experienced project manager and I will miss her more than I think she will miss her role. Over the last 5 weeks, I keep catching myself saying “What would Judy do?“ I don’t know the answer but Judy is just a phone call away. Judy will be missed but not easily forgotten.

 

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.

 

To unsubscribe from the On Target mailing list, click on the following link: unsubscribeontarget@targethealth.com

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Target Health – Champions of the Paperless Clinical Trial™

 

A good time was had by all at DIA this year. We were able to demo both the current version of Target e*CRF® a one log-in, web based, paperless clinical trial solution built by Target Health Inc., aka, the “Champions of the Paperless Clinical Trial.™

 

Starting with Target e*ICF™ and all the way to patient lock, no need to travel outside the website. Not only does the site use one website for signing of Target e*ICF™, data entry and randomization, but study monitors can create and sign monitoring reports, perform central monitoring, track IMP from depot to the study site, and access standard and RBM reports etc. Medical monitors can perform SAE management including initial and follow-up 3500A and CIOMS reports, And yes, a lot more.

 

In addition to the United States, we now have EMA and Australia marketing approvals for products which used our paperless clinical trial solution, which also includes direct data entry (BYOD) at the time of patient encounter.

 

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.

 

To unsubscribe from the On Target mailing list, click on the following link: unsubscribeontarget@targethealth.com.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

The Talented Mr. Farley

James Farley, photographer extraordinaire, friend and colleague, sent us some recent photos. Hard to choose, but we all agreed that one below was exceptional.

 

Here are the specs:

The camera perspective (on a tall tripod) was above the head. That’s how high-up the flowers were. They were at the height of my eyes, as I stood.

RShot on Canon 5D Mark IV with Canon 17mm Tilt-shift lens using Lee Filters 0.6 standard filter.

 

Rhododendrons at Sunset on Roan Mountain, North Carolina, June 14, 2018. Jane Bald and Round Bald in view. © Copyright Advanced Fine Art 2018 / All Rights Reserved

 

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

 

2018 DIA Meeting in Boston

 

Let us know if you are attending, and if yes, visit us at Booth 2337.

This year we will feature:

 

1. CRO services: Reg Affairs, Clinical Research, Biostats, Data Management and Medical Writing

2. Our paperless clinical trial operation

3. Target e*CRF® fully integrated with Target e*CTR®, our patented web-based direct data entry solution

4. Target eICF™ fully integrated with Target e*CRF®

5. A glimpse into our next software version which will be EDC for All

 

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

 

2018 DIA Meeting in Boston: We’ll be at the DIA from June 25th to June 27th

 

Let us know if you are attending, and if yes, visit us at Booth 2337. This year we will feature:

 

1. CRO services: Reg Affairs, Clinical Research, Biostats, Data Management and Medical Writing

2. Our paperless clinical trial operation

3. Target e*CRF® fully integrated with Target e*CTR®, our patented web-based direct data entry solution

4. Target eICF® fully integrated with Target e*CRF®

5. A glimpse into our next software version which will be EDC for All

 

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

 

Memorial Day Weekend

 

On this Memorial Day weekend, we salute the brave men and women who respond to the call and join the military, dedicating their lives to the protection of this great country. Nothing is more precious than life; therefore, nothing is a greater gift, or more heroic, than offering one’s life to defend one of mankind’s great social experiments, America, the beautiful.

 

Springtime in NYC

 

This past Friday was a beautiful day, so we decided to stroll through Central Park. The rhododendrons were flowering and if you look closely, you will see 5th Avenue in the background

 

Springtime in NYC – ©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. 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 2018 Conference – Tel Aviv

 

Target Heath just returned from the 17th MIXiii-BIOMED 2018 Conference and Exhibition held May 15-17, 2018 in Tel Aviv, Israel. Target Health has been working in Israel since 2001 and has developed long lasting and successful professional and personal relationships, including approvals of products being marketed globally.

 

This year, BIOMED explored the following:

 

Digital Health, IoT, and Big Data – New Armamentarium in Medicine

Next Generation Oncology Treatments

Brain Health

Personalized Diagnostics and Treatments

Fighting Rare Genetic Diseases Using Novel Therapeutic Approaches

Nanomedicine and its Role in New Medical Therapeutics

From Academia Research to Industry

Cutting Edge Medical Device Technologies: Metabolic, Ophthalmology

Novel Clinical Trial Designs and Technologies to Accelerate Drug Development

 

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

 

eClinical Forum Spring Meeting 

 

Last week, Les Jordan and Jules Mitchel attended the Spring Meeting of the eClinical Forum hosted by our friends and colleagues at BMS. The eClinical Forum is a global network of peers which provides a non-competitive environment for innovation, learning and collaboration in clinical research. The meeting was attended by big pharma, EMR companies, CROs, ePRO suppliers, site management companies, and other parties committed to optimizing and modernizing clinical trials. Target Health was very pleased that Les presented on the topic of mobile devices and showcased our collaboration with Pill Tracker as an example of full integration with EDC systems. We also had discussions with the EMR companies who showed interest in our eSource offering and potential integration programs.

 

Les Jordan presenting at the eClinical Forum. ©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. 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

 

Transitioning Clinical Trial Paper Source Records to the Digital World

 

We would appreciate any thoughts on the following.

 

Back in the “old days,“ data collected from paper source records were transcribed to paper case report forms, which were then “mailed“ to the pharma company to perform data entry. When EDC systems were established, the pharmaceutical industry transferred the transcription of these data, by the sites, to the EDC systems. As a result, with the concept of the need to perform 100% source document verification (SDV), the workload for both the sites and CRAs did not change. What did change was that data entry into electronic databases no longer was performed by pharmaceutical companies or CROs, but was now performed by the sites.

 

The whole idea behind efficiencies of electronic systems is interoperability. Nevertheless, there is a new phenomenon on the horizon which is perhaps being perceived as an advantage by clinical research sites. The sites are now being being told that they can create their own electronic source documentation, not dissimilar from creating a paper source record. The big question is not about the validation of these systems, which of course could be an issue, but how these data are mapped and eventually transferred to the study database. We were told recently, that sites are re-entering these electronically collected source data into EDC systems by opening 2 screens, and then entering the data a second time. Are we going to end up with just another version of SDV? Imagine having to deal with transferring these data from multiple site source systems into one or more EDC systems. This challenge is also not different where source data are collected within multiple EMR systems.

 

There are several alternative solutions to support the paperless clinical trial by eliminating or reducing paper source records generated by the sites. Target Health has developed and implemented a patented bring-your-own-device (BYOD) web-based system, that allows for direct data at the time of the office visit, with the simultaneous creation of  electronic source documents. This user friendly system allows for the generation of read-only files maintained under the control of the sites, prior to the data being transferred to the EDC database. There now both FDA and EMA approval of products developed using our system. Other systems include dedicated tablets that are distributed to the clinical sites that also allow for direct data entry at the time of the patient encounter. In addition, real-time transfer of data from multiple EMR systems into one EDC data base is in the very near future, as well as direct capture and integration of data coming from mobile devices.

 

Springtime in NYC

Finally Spring has arrived in NYC. ©Target Health Inc. April 2018

 

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

 

World Orphan Drug Congress

 

Target Health has extensive experience in Orphan and Rare Diseases including FDA approvals and multiple Orphan Drug Designations.

 

For those attending the World Orphan Drug Congress, April 25-27 at the Gaylord National Harbor Hotel in Oxon Hill, MD, please reach out to Warren Pearlson, Target’s Director of Business Development who will be attending. Warren can meet with you to discuss our Regulatory Strategy and Services in the Orphan space, and delineate how our Full-Service eCRO, supported by Target Health’s paperless eSource EDC software platform, enables efficient and cost-effective Clinical Trials.

 

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

 

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