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

 

Winter in April – NYC 2018

 

Last week, another snow storm hit New York City. The barely visible view is the Empire State Building.

NYC: Winter in April – 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

 

Rare and Orphan Diseases

 

This past week, BioNJ (New Jersey) sponsored a meeting entitled: “Developing Rare Disease Regulatory Strategy Under Current Global Regulatory Statutes.“ Our friend and colleague Dr. Andrew Mulberg chaired the meeting and attendees were from patient advocacy groups, industry and FDA. There was the theme that clinical programs and regulatory strategies for rare and orphan diseases must be different from traditional development program, and that the “Totality of the Evidence“ must be part of the strategy. While there are no black and white formulas to address the “Totality of the Evidence“, it was clear that Quality of Life must be a key factor, especially when there are soft and non-validated clinical endpoints. Another striking idea was for companies collaborate with each other and FDA when working on the same indication. This way all can use the same pre-competitive natural history and available patient data, and then agree on how to study effectiveness. This would allow for the harmonization of drug development and avoid sponsors going in different directions when studying the same patient population. One exciting breakout session was on the roles of Registries both as sources of natural history data, as well a backbone for registry embedded clinical trials.

 

Target Health is very active in the orphan and rare disease spaces and we have come up with creative strategies to accelerate time to market.

 

Spring is Here, a Little Late this Year: 2018 The Big Apple

 

Last week, the 4th nor’easter storm hit New York City. It snowed all day and accumulated over 1 foot of snow in the NY metropolitan area.

 

Crocuses and others, struggle up through the snow 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

 

ACRP Blog Interviews Target Health on the Paperless Clinical Trial

 

As a followup to an ACRP Webinar on March 7, entitled: “Regulatory Concerns When Running Paperless Clinical Trials,“ presented by Jonathan Helfgott, formerly of FDA and Jules Mitchel, President of Target Health Inc., Michael Causey, of the ACRP Blog interviewed Dr. Mitchel. The interview is entitled “Paperless Clinical Trials Gain Momentum.“ We were told that this was one of the most popular webinars with over 350 attendees.

 

If you want a copy of the slides, just let us know.

 

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

 

Water Running Down Glacial Rocks in New York’s Central Park

Water Running Down Glacial Rocks in Central Park in New York City, Target Health Inc.

 

Last week, the snow had melted after a March storm. As we were returning from dinner along Central Park West, we noticed water running down these gorgeous glacial rocks behind a park bench. We quickly took this picture with our iPhone and wanted to share this almost surreal view of a modern-day park bench juxtaposed with wet ancient rocks.

 

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

 

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

 

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