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

 

Attack in New York City

 

This week, NYC was attacked again, this time by a deranged van driver, killing 8 people, and injuring many others. Our hearts and prayers go out to the families of those who were killed and injured. When it comes to tolerance, our city is open, gentle, and a true melting pot welcoming all to the American Dream.  Hopefully, the day will come, when Martin Luther King’s dream will become a reality, where we tolerate differences, share ideas, listen to each other and compromise.

 

Let freedom ring! Freedom Tower has replaced the WTC Towers – © 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

 

Who is Target Health and What Do We Do?

 

From time to time we are asked “What is Target Health and What Do You Do?“ So those of you not familiar with our services, here they are.

 

Target Health Inc., a full-service e*CRO, is committed, through creative collaboration, to serve the pharmaceutical community with knowledge, experience, technology and connectivity. Our goal is to get products to the market to help those in need. Our pledge is to optimize the life cycle of drugs, biologics and devices with expertise, leadership, innovation and teamwork. We provide superior, consistent performance with a cutting edge, diverse team with the highest standards of ethical conduct and integrity.

 

Our team is both home-grown and from the Industry, with many of our employees have been with us for 10, 15 and yes, some just about 20 years. Our industry-based employees come from Amgen, Boehringer Ingelheim, Certara, Eisai, Microsoft, NY Blood Center, Pfizer, Quintiles, Regeneron, Sanofi, Siemans, Wyeth, etc.

 

We have been inspected twice by FDA as part of 2 pre-approval inspections with no 483 findings.  Here is an excerpt: “This inspection is a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to ensure that the rights, safety, and welfare of the human subjects of those studies have been protected.“ “From our evaluation of the establishment inspection report and the documents submitted with that report, we conclude that you adhered to the applicable statutory requirements and FDA regulations governing the monitoring practices of clinical investigations and the protection of human subjects.“

 

Our services, in alphabetical order, include:

 

Biostatistics: Led by Leigh Ren, we provide full Biostatistical services including statistical planning, randomization codes, protocol statistical sections, SAPs, TLF’s, statistical reports, etc.

 

Clinical Research: Led by Dave Luke, we manage full paperless clinical programs using top PMs from the industry. We also prepare clinical study reports (CSRs) and prepare manuscripts. Examples of current and past programs include, autism, ADHD, epilepsy, psychiatry, male health, emergency contraception, head lice, periodontal disease, studies in the newborn, etc.

 

Data Management: Led by Yong Joong Kim, we provide full DM services, fully integrated with Target e*CRF®, Data Management plans, DM review during the clinical trial, clean file meetings, CRF annotation, integration with external labs, SDTM mapping, etc.

 

EDC: Led by Joonhyuk Choi, we provide full EDC application services at one website and no required devices. We use Target e*Studio® to build Target e*CRF applications, including on line randomization, direct data entry at the time of patient encounter (Target e*CTR® ; eClincal Trial Record), ePRO, eCOA, management and risk-based monitoring reports, drug supply management, SAE management, onsite and remote monitoring reports, etc.

 

Regulatory Affairs: Led by Mary Shatzoff, we provide strategic planning and regulatory operations services for more than 55 companies. We initiate, coordinate and manage FDA meetings and interactions, and provide paperless regulatory submissions via FDA’s Gateway. Examples of key FDA approvals where we made a difference include, Gaucher Disease, Emergency Contraception, Head Lice, In Vitro Fertilization, Prostate Cancer, Periodontal Disease, Adhesion Prevention in Cardiac Surgery in the Newborn, Urology, Hair Loss in Cancer Chemotherapy, Bone Fracture Healing, etc.

 

Software Development: Led by Les Jordan, the next version of Target e*Studio will allow almost anyone with clinical research experience, to rapidly create and deploy the cost-effective clinical trial of the future, including but not limited to, online randomization, eSource, and full integration with the EHR, mobile devices, telemedicine, etc.

 

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

 

Risk-Based Trial Management/Monitoring Conference

 

CBI’s Risk-Based Trial Management and Monitoring Conference is just TWO weeks away! Join your peers, thought-leaders and trial counterparts to collaborate on the growing challenges and solutions for ensuring RBM data quality. Learn how to reduce the complexity of implementing an efficient RBM methodology, system adoption, process integration and much more! Visit www.cbinet.com/RBM to view the full conference agenda.

 

RBM Risk Assessment ? What are, and how to mitigate the risks from the patient, study, site and sponsor perspectives? – Presented by Dr. Jules T. Mitchel, President, Target Health Inc.

 

Assessing risk is an ongoing process for any industry, and clearly the impact of all risks are not equal. In the clinical research environment, the primary concern is the safety risk to the patient when taking an experimental medicinal product or using an unapproved medical device. Other risks include the impact of not following the protocol and not being complaint with rules and regulations. This session presents a model for risk assessment and provides concrete examples. Risk mitigation:

 

1. Identify risk factors

a) the severity of the event, should it happen

b) the likelihood that the event would happen

c) the likelihood of detecting the event

2. Risk mitigation strategies for each risk

3. Assessment of unique risks associated with specific studies

4. A model is presented with examples

 

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

 

WHAT’S NEW – Champions of The Paperless Clinical Trial and First FDA Approval Using eSource When Entering Data in Real-Time at the Clinic Visit

Champions of The Paperless Clinical Trial and First FDA Approval Using eSource When Entering Data in Real-Time at the Clinic Visit

 

Target Health Inc. is a software company that provides CRO services, and a CRO that includes software services as part of its offering. Some of our clients just use our software, while others want us to provide CRO services, fully integrated with our software suite. In our most recent paperless clinical program in dermatology, sponsored by Big Pharma, 65% of patients electronically signed the informed consent document, and 90% of forms were entered on the day of the clinic visit; over the course of 12 months, there were just 29 monitoring visits at 13 sites, including 3 sites in Japan, while 151 central monitoring reports were issued and electronically signed. All features, including the monitoring reports, were at one website with no dedicated devices. A major program is ongoing in autism and other programs are starting in psychiatry and diabetes.

 

The first-ever FDA clearance of a direct data entry, eSource program, occurred in 2015.  There were FDA inspections at 3 medical centers and at Target Health; and only one 483 at one of the sites, which was easily addressed. The results were recently published in JAMA.

 

Below describes our software suite:

 

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

 

Clinical Trials Transformation Initiative (CTTI)

 

The Clinical Trials Transformation Initiative (CTTI) is a public private partnership with Duke University and FDA with a mission to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. Target Health has been a member of the Steering Committee since 2008, and Dr. Mitchel had the honor, between 2014-2015, to sit on the Executive Committee, representing the Steering Committee.

 

This past week, the Steering Committee met in D.C. with the theme of how to implement CTTI recommendations. It was a very stimulating meeting that included presentations and breakout sessions. Our take-away of the meeting is that it will take leadership and ownership to make the changes needed to completely modernize the clinical trial enterprise. All agreed that we look forward to examples of how CTTI companies are implementing changes.

 

At Target Health, the impact of CTTI has been in the area of managing clinical trials using principles of Quality by Design, and our approach to risk-based monitoring, based on the publication of the CTTI Monitoring Survey Project: Monitoring the Quality of Conduct of Clinical Trials: A Survey of Current Practices.

 

Target Health was also a key team member in CTTI’s Registry Trials Recommendations that has provided a pathway for registries to be used for the conduct of more efficient clinical trials, bringing new treatments to patients faster. Registries are data collection tools typically used to better understand long-term trends in a specific population, such as patients with a particular disease or exposure to a certain treatment. However, if designed appropriately, registries can be used as a data source within which clinical trials can be performed. FDA recently signaled a commitment to developing policies regarding the use of registries and other forms of “real-world evidence“ for research, including clinical trials. While registries have long been used to support safety evaluations, their use for efficacy evaluations is a newer practice. CTTI’s recommendations outline best practices for assessing and designing registries so that the data should be able to meet expectations for FDA review of new products. The recommendations can be applied to existing registries or for developing new registries. The goal is to increase the practice of leveraging registries to facilitate high-quality clinical trials at lower costs.

 

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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