Target Health Inc. – What We Do and How We Do It

 

Several times a year we get asked by current and potential clients: Exactly what services do we provide. Our answer is that basically we are a Pharmaceutical or Medical Device Company without our own products, but with the staff, software and skills to take your unique product to the market. Our experienced staff are home grown, as well as coming to us from companies like Pfizer, Microsoft, Wyeth, Amgen, Teva, Boehringer Ingelheim, Quintiles and more.

 

TARGET HEALTH INC. is a New York City based full service eCRO with staff dedicated to all aspects of Drug and Device Development including: Strategic Planning, Regulatory Affairs, Toxicology, Clinical Research, Biostatistics, Data Management and Medical Writing.  In addition, we have developed innovative web-based software tools that support the paperless clinical trial thus providing our clients with a significant productivity edge.

 

Why Do Companies Work With Target Health?

 

1. Drug/Device Development is Our Business

2. In Business since 1993

3. Extensive Experience with FDA

4. Track Record of NDA, PMA, BLA, 1510(k) and Other Regulatory Approvals

5. Broad Clinical Backgrounds

6. Experienced Management Team

7. >50% of Employees 5+ Years at the Company

8. Champions of the Paperless Clinical Trial

9. We Are Not Just a Technology Company

10. EDC (Target e*CRF®) since 1999

11. Always Meet Deadlines

12. Repeat Business From Our Clients

13. We Measure Our Success By Your Success

 

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

 

Data Management and the Paperless Clinical Trial at Target Health Inc.

 

When developing a drug, biologic or device, it is all about the data. Data need to be accurate, precise, clean and validated so regulators and the public have confidence with what is reported by pharmaceutical and device companies. At Target Health, we have developed a 21CFR Part 11 compliant electronic data capture (EDC) system that allows for direct data entry of clinical trial data over the web. This patented system allows for the creation of source records, controlled by the clinical site, before the data hit our database. Target Health Inc. data management plans are created by the best team in the industry, which includes edit check and data transfer specifications, as well as data review plans to assure data consistency. Finally, Quality by Design meetings take place with our development team, including the sponsor and all relevant stakeholders, to do real-time data reviews. Consequently, we have the ability to respond rapidly to any data issues whether from specific sites, monitoring oversite, or the EDC system itself. As a result, we can lock databases within several weeks of the last patient, last visit (LPLV) monitored.

 

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

 

Rare and Orphan Diseases at Target Health Inc.

 

One of Target Health’s expertise is in the area of rare and orphan diseases. Our expertise is not just in obtaining Orphan Drug Designations in multiple areas, but also the regulatory strategy to optimize the path to the market. For one program, we worked with our client to propose to FDA to go directly from Phase 1 in normal volunteers to a pivotal trial with 30 patients with just 2 doses of the drug and no placebo arm. The drug was approved and the company saved at least 2 years by not having to do a phase 2 study. In additional, the NDA was a rolling submission, so that when the last patient visit occurred in September, the final NDA was submitted in December, just 3 months later. Of course, the planning of the submission started a year in advance which made for a smooth transition. A recent Orphan Drug Designation was approved for a rare epilepsy in children and a Fast Track Designation cleared for a metabolic disease.

 

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

 

ACRP Webinar: Regulatory Concerns When Running Paperless Clinical Trials

On March 7, 2018, Jonathan Helfgott (formerly at FDA) and Jules Mitchel (President of Target Health Inc.) will be presenting an ACRP Webinar entitled: “Regulatory Concerns When Running Paperless Clinical Trials.“ Here is a summary:

 

The FDA and other regulatory bodies have issued multiple guidance documents addressing requirements when using technology tools to execute paperless clinical trials. The push from the regulatory agencies has occurred despite a risk-averse pharmaceutical industry, still conflicted about living in a “paper world.“ This risk aversion is in part due to an irrational fear by sites and sponsors of receiving a FDA Form 483 when an FDA inspector discovers that a patient was born in 1982, when in the study database it is recorded as 1983; and it did not matter. Additionally, the clinical sites are also fearful of losing business as a result of any FDA Form 483 finding, however minor.

 

The following are examples of regulated clinical trial software: 1) Data capture (EDC) systems; 2) Electronic informed consent; 3) Electronic trial master file (eTMF): 4) ePRO and eCOA; 5) Dedicated tablets collecting and storing data in real time; 6) Mobile Apps; and 7) Web-based systems collecting data in real time which transmit the data to the study database only after the source record is securely received and stored in an independent eSource storage location under control of the study site.

 

Upon completion of this Webinar, attendees should be able to:

 

1.     Understand the future landscape of paperless clinical trials

2.     Understand regulatory concerns when running paperless clinical trials

3.     How to “separate toys from tools“ when choosing mobile and related devices

 

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

 

The Clinical Trials Transformation Initiative 10 Year Anniversary  

The mission of the Clinical Trials Transformation Initiative (CTTI) is “To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials.“ CTTI’s 10th Year Anniversary will be celebrated in Washington on February 5-6, 2018.

 

Target Health Inc. has supported the CTTI Mission since joining CTTI on 8 August 2008, and we congratulate CTTI for its major contribution to the clinical trials enterprise over the past 10 years. When we joined in 2008, our friend and colleague Dr. Judith Kramer wrote this in response to our commitment to join: “Likewise;  I really enjoyed our conversation.  I am very pleased that you decided to join CTTI as I think you will be an extremely valuable participant at the “table”.

 

As part of Target Health commitment to the CTTI Mission, Jules Mitchel, President of Target Health was honored to serve on the Executive Committee of CTTI representing the Steering Committee, and was one of the authors of the 2011 publication on “Monitoring the quality of conduct of clinical trials: a survey of current practices.” This seminal CTTI publication was coauthored by: Briggs W Morrison, Chrissy J Cochran, Jennifer Giangrande White, Joan Harley, Cynthia F Kleppinger, An Liu, Jules T Mitchel, David F Nickerson, Cynthia R Zacharias, Judith M Kramer, James D Neaton. The esteemed Target Health software development team also created the database used to collect the survey information.

 

A major highlight last year was a joint NIH Collaboratory Grand Rounds Webinar presented with John Laschinger, CDRH/FDA and Jules Mitchel: entitled CTTI Registry Trials Project: Evaluation and Design of Registries for Conducting Clinical Trials.

 

Current projects that Target Health is actively involved with include Mobile Devices and Registries. There is an interview of Dr. Mitchel on the CTTI website.

 

Here is what we wrote in ON TARGET in 2008:

 

Target Health is pleased to announce that it has joined the Clinical Trials Transformation Initiative (CTTI).

 

CTTI, a public-private partnership with FDA’s Office of Critical Path Programs and Duke University, is mandated to bring together all interested stakeholders in order to identify practices that, through broad adoption, will increase the quality and efficiency of clinical trials. It is envisioned that this group will seek out new methods and technologies that improve safety, enhance the quality of information from trials, and make the research process more efficient. CTTI will identify best practices, conduct empirical research, and develop new standards for future research efforts. .

 

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

 

A Breathless Sunset in New York City as Seen From the 24th Floor

 

Every once in a while the sky explodes. Two days after a big storm a gorgeous sunset surprised us. The entire company stopped to view one of the most breath-taking views we have ever seen. It is our pleasure to share this photo with our readers from all over the world as we welcome in the new year.

 

Sunset Behind the Empire State Building ©Jules T. Mitchel

 

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

 

Wow!! Celebrating 23 Years of ON TARGET

 

We were rummaging through some papers the other days and found our first ON TARGET Newsletter from 1994. While the company was founded in 1993 by Joyce Hays, our CEO, as a marketing company, the pharmaceutical drug and device development services began in 1994.

 

We are thrilled that over 6,200 people have subscribed to one of the oldest published newsletter in the pharmaceutical industry. Readers include colleagues, friends, regulators and just regular folks from all over the world, no matter what ethnicity, religion, or political viewpoint. We try to bring people together as only together, can we beat diseases, poverty and inequality throughout the world.

 

We want to thank our loyal readers and followers who still come up to us and say, wow! That recipe last week was really special.

 

Please send any Holiday wishes to us and we will share them.

 

Snowy weekend 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

 

Holiday in New York City

 

December begins the holiday season in NY for Target Health with red poinsettias everywhere in our offices on Madison Avenue. Holiday wishes to all.

Holiday time the 23rd and 24th floors. ©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

 

Sunset in New York City

 

As the holiday season approaches, and the days are shorter, the sunsets in NYC are breath-taking. Fortunately, the corner offices on the 24th floor faces SW, so the views are beyond spectacular.

Words cannot describe this gorgeous view from the 24th Floor.  ©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

 

George Washington was Inaugurated in New York City

 

On Thursday, April 30, 1789, on the balcony of Federal Hall in New York City, New York George Washington was inaugurated as the first President of the United States. Thus ends the final chapter of a fascinating book entitled, “A Brilliant Solution: Inventing the American Constitution,“ by Carol Berkin. This is a must read for anyone fascinated by the foundations of the American experience in governing. But most important to note is the profound insight our founders had into human behavior and the human psyche, and the intelligent and prescient controls they put in place to avoid concentration of power. Our goal is to share a copy of the book on your next visit to our offices.

 

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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