Scott Mellis, MD, PhD on Safari

 

Our very good friend and colleague, Dr. Scott Mellis, Vice President, Early Clinical Development and Experimental Sciences, Rare Diseases at Regeneron Pharmaceuticals, took an adventurous trip to Africa and came back with some extraordinary photos.

Cheetahs enjoying a family meal in the Serengeti. ©Scott Mellis, M.D., Ph.D.

 

Lion outside safari vehicle.  Ngoro Ngoro crater © Scott Mellis, M.D., Ph.D.

 

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

 

DIA Annual Meeting – See Us at Booth 913

 

We hope to see you in Chicago and join us on our couches.

A reminder that Dr. Jules T. Mitchel will be chairing a Content Hub presentation / conversation which will take place at the DIA Annual Meeting in Chicago. Please join us at 4pm on Tuesday June 20, 2017 at the S400 Concourse. The topic is:

 

How eSource Solutions are Impacting Clinical Research Sites, Patients, Regulators and Drug and Device Companies

 

Co-presenting will be our colleagues and friends:

 

Jonathan Helfgott, MS, who is currently the Coordinator of the Regulatory Science Graduate Program at Johns Hopkins University, and previously the Associate Director for Risk Science at FDA CDER OSI and the main author of FDA’s eSource Guidance, and;

 

Mitchell D. Efros MD FACS, CEO of Verified Clinical Trials

 

The following is an outline of the presentation and we look forward to seeing you there:

 

In the not too distant future, we, as an industry will execute, manage and monitor clinical trials the same way we execute, manage and monitor banking transactions online, quickly and without the need to maintain paper records. However, as we bring new and innovative technology solutions to the market, we must assess and address the concerns of all the stakeholders within the clinical trial enterprise. We need to assure patients, clinical research sites, pharmaceutical and device companies, as well as regulators, that there will be improved efficiencies, improved data quality and integrity, improved patient safety, reduced fraud and an overall better experience during the clinical trial process. Topics to be addressed include clinical site acceptance, regulatory concerns, software validation, risk assessments, change management within companies, and a comprehensive assessment of the risks and rewards.

 

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

 

DIA Annual Meeting Presentation on the Paperless Clinical Trial and its Impact on the Clinical Trial Enterprise

 

Target Health Inc. is pleased to announce that Dr. Jules T. Mitchel will be chairing a Content Hub presentation/conversation which will take place during DIA Annual Meeting in Chicago. Please join us at 4pm on Tuesday June 20, 2017 at the S400 Concourse. The topic is:

 

How eSource Solutions are Impacting Clinical Research Sites, Patients, Regulators and Drug and Device Companies

 

Co-presenting will be our colleagues and friends:

 

Jonathan Helfgott, MS, who is currently the Coordinator of the Regulatory Science Graduate Program at Johns Hopkins University, and previously the Associate Director for Risk Science at FDA CDER OSI and the main author of FDA’s eSource Guidance, and;

 

Mitchell D. Efros MD FACS, CEO of Verified Clinical Trials

 

The following is an outline of the presentation and we look forward to seeing you there:

 

In the not too distant future, we as an industry will execute, manage and monitor clinical trials the same way we execute, manage and monitor banking transactions online, quickly and without the need to maintain paper records. However, as we bring new and innovative technology solutions to the market, we must assess and address the concerns of all of the stakeholders within the clinical trial enterprise. We need to assure patients, clinical research sites, pharmaceutical and device companies, as well as regulators, that there will be improved efficiencies, improved data quality and integrity, improved patient safety, reduced fraud and an overall better experience during the clinical trial process. Topics to be addressed include clinical site acceptance, regulatory concerns, software validation, risk assessments, change management within companies, and a comprehensive assessments of the risks and rewards.

 

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

 

CTTI Registry Trials Recommendations Now Publicly Available

 

This is a must for those interested in clinical trials of the future.

 

Recommendations from the Clinical Trials Transformation Initiative (CTTI) Registry Trials Project were publicly announced last week in a CTTI-hosted webinar. The recommendations describe how to design new registries or evaluate and modify existing registries to conduct clinical trials suitable for regulatory purposes.  By applying these recommendations, stakeholders can make registries into reusable platforms for clinical trials.  CTTI has invited interested parties to consider the application of these recommendations in their clinical trials, and encourages sharing the recommendations and webinar recording with colleagues.

 

The Team Leaders on the project included:  Dawn Flick (Celgene), John Laschinger (FDA), Ted Lystig (Medtronic), and Jimmy Tcheng (Duke)

 

Team Members included:  Chunrong Cheng (FDA), Christopher Dowd (Cystic Fibrosis Foundation), Nicolle Gatto (Pfizer), Lauren Mclaughin (Michael J Fox Foundation for Parkinson’s Research), Stephen Mikita (Patient Representative), Kristen Miller (FDA), Daniel Mines (Merck), Jules Mitchel (Target Health), Magnus Petterson (AstraZeneca), Sunil Rao (Duke), Arlene Swern (Celgene), and Emily Zeitler (Duke)

 

Project ManagersSara Calvert and previously Steve Mikita

 

Webinar Presenters:

John Laschinger, MD, Medical Officer, Center for Devices and Radiological Health, US Food and Drug Administration

Jules Mitchel, MBA, PhD, President, 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

 

CTTI Recommendations on Registry Trials

 

Last week, Target Health was honored as Dr. Jules Mitchel joined Dr. John Laschinger (FDA), for a Clinical Trials Transformation Initiative (CTTI) Webinar on CTTI’s recommendations on how to design and use registries for prospective clinical trials. The Webinar attracted more than 200 participants and the questions from the attendees were all “on target.” According to the CTTI website, “CTTI’s recommendations for registry assessment and design can assist in making embedded clinical trials suitable for regulatory purposes. By using registries as a reusable platform for evidence generation, we can improve the efficiency of clinical trials and bring new treatments to patients faster.”

 

The recommendations are now posted on the CTTI website.

 

Holden Beach, NC – Pier, Sunset

 

Dr. Mitchel is in Israel right now at the Biomed meeting, but had the pleasure of being in North Carolina last Wednesday. Our good friend and colleague James Farley was at the meeting and shared some his great photos, in between an intense day of consulting.

 

It’s been a while, since James, photographer extraordinaire, has sent out any photos as he has recently transitioned all of his landscape, architectural and macro/wildlife photography to Advanced Fine Art. These photos were taken at Holden Beach, NC  in mid-April, during Spring Break.

 

According to James, make sure to zoom-in on the viewer! Even on this resampled version, there is a lot of detail!  :-)))  Shot on his Canon 5D Mark IV and 17mm Tilt-shift. The photo under the pier was a 4-second exposure.

 

©Advanced Fine Art 2017

 

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

 

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

 

← Previous PageNext Page →