Conference: eSource Data in Clinical Investigations – May 2-3, 2017 – Doubletree Center City, Philadelphia, Pa

 

Target Health Inc. is pleased to announce that Dr. Jules Mitchel will be presenting at CBI’s 4th Annual Bootcamp on eSource Data in Clinical Investigations. The conference aims to initiate meaningful dialogues, through collaborative sessions and investigative case studies, around early successes, challenges and failures, so that one can build an eSource adoption business case for senior leadership addressing balance of risk and cost.

 

Dr. Mitchel’s presentation is entitled: “The Future is Now: How  to Obtain Stakeholder Buy-in and Initiate the Migration to eSource.” In this case study, you will learn how eSource reduced monitoring and increased overall data quality, as well as how to convince stakeholders to invest in eSource. You will also learn of the current challenges of interoperability between EHR and eSource and what the long-term strategy looks like in moving away from EDC as we know it today.

 

Please Mention Promo Code: NCE547 for a $500 discount when you register at the conference www.cbinet.com/esource.

 

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 or Ms. Joyce Hays. 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

 

Climate Change: Springtime in NYC: First a Snow Storm, then Sun and Flowers

 

The photo below was taken in the front gardens of our building in NYC showing the crocuses pushing through.

 

On this same morning we had a very cold snow storm, but by the time I was coming home in the afternoon, the sun was out and crocuses blooming.

 

First 2017 crocuses blooming in our front garden. © Joyce Hays, 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 or Ms. Joyce Hays. 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 Website Launched

 

Target Health Website has a new look, although the banner designed by CEO Joyce Hays, remains as well as the famous Leaping Dog, a feature of our website from inception. We are also very proud of our publications, many of which are prescient and trailblazing.

 

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 or Ms. Joyce Hays. 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

 

Orchid Blossoms on the 24th Floor in February

 

Every year or so, an orchid blossoms in the corner office of Target Health Inc. on the 24th Floor at 261 Madison. With the temperature in February reaching 60 degrees in NYC, maybe Biology is telling us something.

 

Orchid Blossoms on 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 or Ms. Joyce Hays. 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

JAMA Publishes Results of the First FDA Approved Product that Used eSource (Target e*CTR®) to Collect and Store Real Time Data in the Clinic

 

Many years ago a very senior executive at Pfizer told me (Jules Mitchel, a proud Pfizer alumnus) that if you can just get a product approved that used your paperless solution, we will all jump in. He added that Big Pharma will not take the chance itself, but you guys are “crazy enough to even try, so just do it.“  Well, not only did we do it, but the results of the clinical program was just published in JAMA.

 

On 14 February 2017, JAMA, the Journal of the American Medical Association, (volume 317:606-614) published a paper entitled “Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer.“ Target is honored to have managed and executed this entire program, and to be co-authors on this ground-breaking treatment for women undergoing breast cancer chemotherapy.

 

From the clinical research operational perspective, this study was executed using Target Health’s patented, web-based, eSource solution, Target eClinical Trial Record (Target e*CTR®), which was fully integrated with Target e*CRF®, Target Health’s proprietary EDC system. Both Target Health and 3 major medical centers were subject to FDA inspections which were passed with no findings related to Target Health’s paperless clinical trial solution, and Target Health’s approach to risk based monitoring and Quality by Design. There was only one minor finding at one of the research sites related to GCP, as nothing is perfect.

 

Related articles include: Regulatory Considerations when Designing and Running 21st Century Paperless Clinical Trials and eSource Records in Clinical Research, and more papers can be found on our website.

 

Sunrise in NYC

 

Every once in a while, the early bird catches the worm. Another spectacular sun rise looking towards Europe.

 

Sunrise of 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 or Ms. Joyce Hays. 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

Evening View From the Water Club – NYC

 

This week it snowed all morning in NYC followed by a beautiful clear evening. Before sunset, we were joined by our good friend and colleague, Silvana Cappi, VP Biometrics, at Ferring Pharmaceuticals who took this spectacular photo of the East River looking North. Can you see the snow and what looks like a palm tree? Also, if you look carefully, you can see the UN building in the background.

 

View of the East River From the Water Club.©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 or Ms. Joyce Hays. 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

Morning View From the 24th Floor at 261 Madison

 

Target Health has been on the 23rd and 24 Floors at 261 Madison since 2001. There are a lot of breath-taking views at sunset which we have shared for many years, but this morning view of shadows, the spectacular sky and eclectic architecture, has left us breathless.

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 or Ms. Joyce Hays. 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

Orphan Drug Development at Target Health Inc.

 

Target Health is very pleased that it has prepared, submitted and obtained over 20 orphan drug designations, with 3 of these products reaching the market. There were 2 additional orphan programs in which Target Health played a major role. One program was in cystic fibrosis, on behalf of our good friend and colleague, Dr. Tibor Sipos President and CEO of Digestive Care Inc, which was approved by FDA in 2012, without an ODD. The second program was for Regeneron, where Target e*CRF was used in the development program of Arcalyst, for the treatment of Cryopyrin-Associated Periodic Syndromes which was approved in 2008.

 

Ongoing clinical development programs treating orphan diseases include Dravet syndrome, Fabry disease, Growth Hormone, and Huntington’s disease.

 

The following is the list of orphan diseases for which Target Health obtained ODD on behalf of its clients:

 

Alagille syndrome; Aplastic anemia; Behcet’s disease; Burn progression in hospitalized patients; Caries prevention, head and neck cancer; Cushing’s syndrome secondary to ectopic ACTH secretion; Debridement in hospitalized patients with 3rd degree burns (EMA Approved 2012); Edema-related effects in hospitalized patients with 3rd degree burns; Fibrolamellar carcinoma (FLC); Fungal Infections; Gaucher Disease (NDA Approved 2012); Growth Hormone (Licensed to Big Pharma); Hereditary angioedema (NDA Approved 2011); Hodgkins Lymphoma; Intradialytic Hypotension (symptomatic hypotension in the immediate post-dialytic period); Invasive aspergillus infections; Multiple myeloma; Osteonecrosis of the jaw; Ovarian cancer; Rabies; Scleroderma.

 

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 or Ms. Joyce Hays. 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

 

Ongoing and Completed eSource Programs at Target Health and ICH E6(R2)

 

Target e*CTR® (eClinical Trial Record) is Target Health’s patented eSource solution fully integrated with Target e*CRF®. A de novo 510(k) was cleared in December 2015 that used direct data entry at the time of the office visit, and an NDA was submitted to FDA with 7 studies which all used Target e*CTR. There were no FDA inspection findings in any of these programs. Ongoing studies include a large pivotal trial in Autism, a phase 2 study in dermatology and a device study. A new study in psychiatry will start in Q2 2017 as well as several other programs. Recently, a phase 2 study in neurology was completed with 900 subjects at 40 clinical sites.  Completed programs include ADHD, urology, and phase 1 studies.

 

As part of the ICH E6(R2), sections were modified to address electronic records and associated roles and responsibilities. Target Health Inc. congratulates our colleagues at ICH who clarified the acceptance of electronic records as original records in lieu of a requirement to have paper source records.

 

The following are some highlights of the revisions as they relate to electronic records. Also refer to a paper recently authored by Mitchel and Helfgott, published on 4 January 2017 in Applied Clinical Trials entitled, “Regulatory Considerations when Designing and Running 21st Century Paperless Clinical Trials

 

 

Glossary: Certified Copy

A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original. (section 1.6.3)

 

Section 5. Sponsor

Record Access: The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection. (Section 5.15.1)

 

6.4 Trial Design

The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design, should include: The identification of any data to be recorded directly on the CRFs (i.e., no prior written or electronic record of data), and to be considered to be source data. (section 6.4.9)

 

8. Essential Documents for the Conduct of a Clinical Trial (Addendum)

 

The sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should provide for document identification, version history, search, and retrieval.

 

The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the sponsor. The sponsor should not have exclusive control of those data.

 

When a copy is used to replace an original document (e.g., source documents, CRF), the copy should fulfill the requirements for certified copies.

 

The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

 

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 or Ms. Joyce Hays. 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 Paperless Clinical Trial – New Publication in Applied Clinical Trials

 

On 4 January 2017, Applied Clinical Trials published an online paper, entitled, “Regulatory Considerations when Designing and Running 21st Century Paperless Clinical Trials.“ The paper is coauthored by Jonathan Helfgott, MS, former the Associate Director for Risk Science at FDA CDER OSI and the main author of FDA’s eSource Guidance, and Jules Mitchel, MBA, PhD, President, Target Health Inc. Jonathan is currently the Coordinator of the Regulatory Science Graduate Program at Johns Hopkins University.

 

The following are some excerpts from the paper which is meant to be both informative and evocative.

 

 

Introduction: The regulatory push to the paperless clinical trial has occurred despite a pharmaceutical industry that has been risk-averse in adopting modern-day technology tools that could support clinical trials. This risk aversion is in part due to fear by sites and sponsors of receiving a FDA Form 483. What if the FDA turns down an application if it discovers that, for example, a patient was born in 1982, when in the study database it is recorded as 1983, even when there is no impact on the study results? The clinical sites are also fearful of losing business as a result of any FDA Form 483 finding, however minor.

 

Risk Assessments: A quality by design (QbD) methodology, which includes a risk assessment and risk mitigation strategies, is a critical exercise when building software. Using a Boeing 787 analogy, a plane has several electrical systems that control the engine and the coffee machine. We should not assign the same risk to the coffee machine not delivering hot coffee as we do to the engine failing on takeoff.

 

Discussion and Conclusion: For more than a decade, technologies and processes allowing for the paperless clinical trial have been substantiated and encouraged from both the business and regulatory perspectives. The time is ripe to put away fears of regulatory sanctions when using modern technology, and make changes to modernize and optimize the drug and device development processes that will ultimately, positively, support the regulatory approval process.

 

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 or Ms. Joyce Hays. 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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