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

 

eClinical Forum Meetings in Europe and the USA

 

Next week, Les Jordan, Vice President, Chief Product Evangelist at Target Health will be at the eClinical Forum European Meeting, and will be presenting on Agile Software Development. The meeting, hosted by Bayer, will be held at the Steigenberger Hotel in Berlin, Germany on 26-28 September 2017.

 

The objectives of the meeting are to:

 

1. Leverage the knowledge of eClinical Forum members to remain up-to-date on current thinking and to explore emerging technology, process, people and regulatory trends.

 

2. Drive performance by developing an unrivalled insight into global best practices, risks and opportunities.

 

3. Design the future of eClinical Research by working with peers to develop leading-edge visions and implementable strategies.

 

4. Build a network with global experience and insight for beyond-the-workshop interaction.

A draft agenda will be issued shortly.

 

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

 

Jules Mitchel Receives PharmaVOICE Red Jacket Award

 

This past week, PharmaVOICE honored their PharmVOICE 100 and Red Jacket awards at the Alexandria Center in NYC. Target Health is pleased to announce that Jules Mitchel, President of Target Health Inc. received the coveted Red Jacket Award, together with Jim Curtis, Remedy Health Media; Cameron Durrant, M.D., Humanigen Inc.; Terry Herring Mission Pharmacal; Brian Loew, Inspire; Matt McNally, Publicis Health; and Wendy White, Wendy White Consulting.

 

RBM 2017 Meeting: Risk-Based Trial Management and Monitoring

 

On November 2-3, 2017, Dr. Mitchel will be presenting at CBI’s “RBM 2017 Meeting: Risk-Based Trial Management and Monitoring,“ being held at the Warwick Rittenhouse Square | Philadelphia, PA. The conference theme is: Enhance Process and System Interoperability to Optimize Data Quality, Improve Trial Efficiency and Ensure Compliance.

 

Dr. Mitchel’s topic is “RBM Risk Assessment – What Risks Are We Assessing from the Patient, Study, Site and Sponsor Perspectives?“ In summary, 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 will present a model for risk assessment and will provide concrete examples of risk factors such as:

 

1. the severity of the event, should it happen

2. the likelihood that the event would happen

3. the likelihood of detecting the event

4. risk mitigation strategies for each risk

5. Assessment of unique risks associated with specific studies

 

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

 

Our hopes and prayers are for those suffering due to the terrible storms going on now in the US, as well as those suffering all over the world. While the tornado this week in New London, Connecticut, reported below, was not as bad as Hurricane Harvey, Hurricane Irma, the terrible earthquake in Mexico and other global disasters due to CLIMATE CHANGE, the world leaders must take heed.  If not, We The People must take charge of our planet. And yes, we still have to reckon with Hurricane Katia in the Gulf of Mexico, and Hurricane Jose which could hit the East Coast of the US. 

In 2006, a study by NASA, published in the Proceedings of the National Academy of Sciences, and authored by Dr. James Hansen of NASA’s Goddard Institute for Space Studies (now a Professor at the Earth Institute at Columbia University), and colleagues from Columbia University, Sigma Space Partners, Inc., and the University of California at Santa Barbara (UCSB), reported that the world’s temperature is reaching a level that has not been seen in thousands of years.  The study concluded that, because of a rapid warming trend over the past 30 years, the Earth is now reaching and passing through the warmest levels in the current interglacial period, which has lasted nearly 12,000 years. This warming is forcing a migration of pathogens, plants and animal species toward the poles.

Listen to a recent interview with Dr. James Hansen.

Listen to Dr. Paul Beckwith, Professor of Climatology at the University of Ontario, talking yesterday about Hurricane Irma.

Climate Change Disrupts all Varieties of Transportation

On Wednesday, 6 September 2017, Target Health took off to attend the DPharm Meeting in Boston. Fortunately, Les Jordan our Chief Software Evangelist, lives in the Boston area.  However, it took Warren Pearlson, BD Director, 8 hours to get to Boston and Jules Mitchel, 6 hours. The tornado in New London, unfortunately, landed on the home of Dave Luke, Sr. Director of Clinical and Scientific Affairs. This same tornado, landed trees onto the train tracks, which caused the lengthy train delays.  A tornado in Connecticut is a rare event.

Our full ON TARGET Newsletter will resume next week.

 

 

Jules Mitchel Receives Red Jacket Award and Time For a Vacation

 

To our loyal readers, friends and colleagues: We are taking time off from the last half of August and the first half of September. See you in September. We started ON TARGET in 1994, first sending the newsletter out by fax. Our weekly newsletter is now being shared with over 6,000 readers each week.

 

For more than a dozen years, PharmaVOICE magazine has been recognizing the most inspirational, motivational, and transformative individuals throughout the life-sciences industry in its annual July/August PharmaVOICE 100 issue. These individuals illustrate what it means to think bigger, do more, and lead with passion and integrity. This year’s distinguished honorees were nominated by thousands of PharmaVOICE readers and were selected for inclusion based on substantive accounts describing how they have inspired or motivated their colleagues, peers, and even competitors; their positive impact on patients, their organizations, and the industry at large; their innovative and game-changing strategies and thinking; their mentorship and guidance to the next generation of leaders; as well as their willingness to give their time and resources to their communities and philanthropic causes. The PharmaVOICE 100 is the premier awards program whose honorees represent a broad cross section of the global life-sciences industry, including the pharmaceutical, biopharmaceutical, biotechnology, contract research, clinical trial, research and development, patient education, advertising, digital, marketing, technology, academia, as well as multiple other sectors. This diverse group of individuals is also unique in that they represent a wide variety of functional areas – ranging from the clinic to the C-suite.

 

Please join the Celebration on September 14 in New York City, where PharmaVoice will be recognizing this year’s honorees as well as PharmaVOICE 100 honorees throughout the years. This is the one event designed to encourage collaboration and networking among a diverse and executive leadership audience. For more details about the third annual PharmaVOICE 100 Celebration, please go to: http://www.pharmavoice.com/pv100-celebration.

 

One of the criteria for being named a Red Jacket is having been recognized previously as a PharmaVOICE 100 honoree, but it’s much more than that. These individuals, who cross a multitude of industry sectors, have raised the bar in terms of what it means to be an inspired leader for their teams, their companies, their communities, and for the industry at large.

 

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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