Target Health Resources

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CROs Working Together

March 29, 2017

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CRO
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Article

Selecting Partners in Countries or geographic areas where it has no existing Infrastructure.

The Electronic Informed Consent Has Arrived

February 15, 2017

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CRO
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Article

The following are points to consider when designing and using an electronic informed consent form (eICF).

Regulatory Considerations for 21st Century Paperless Clinical Trials

February 15, 2017

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CRO
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Article

The FDA and other regulatory bodies have issued multiple guidance documents addressing technology tools that are used in clinical trials.

Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer

February 14, 2017

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CRO
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Article

To evaluate whether use of a scalp cooling system is associated with a lower amount of hair loss among women receiving specific chemotherapy regimens for early-stage breast cancer and to assess related changes in quality of life.

Impact on Data Management of the New Definitions of Data Quality

December 1, 2016

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Data Management
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Article

Risk-based approaches to monitoring (RBM) in clinical research1, 2, characterized by more cerebral operations with focus on critical processes and data components, are growing in popularity.

Risk-Based Monitoring: A Closer Statistical Look

This article proposes a practical risk-based monitoring approach based on published statistical evidence addressing the impact of database changes subsequent to Source Document Verification (SDV).

A Study of the Economic Impact and ROI of the Paperless Trial Master File

October 30, 2015

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Software
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Article

The economic impact of using a paperless trial master file (TMF or eTMF) in a 80-center study in ulcerative colitis.

The Monitoring Dynamic: An Evolving Process and Relationship with the Site

October 1, 2015

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CRO
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Article

In this report we summarize the information presented in the SCRS webinar titled, "The Monitoring Dynamic: An Evolving Process and Relationship with the Site." Our panelists discussed the ways in which representatives from all branches of the industry are working to create a better understanding of, and smoother adjustment to, the use of Risk-Based Monitoring of clinical trials.

Pharmacokinetics of Novel Plant Cell

June 8, 2015

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CRO
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Article

Taliglucerase alfa is a beta-glucocerebrosidase enzyme replacement therapy approved in the United States, Israel, and other countries for treatment of Type 1 Gaucher disease in adults, and is the first approved plant cell—expressed recombinant protein. In this report, taliglucerase alfa pharmacokinetics were assessed in adult and pediatric patients with Gaucher disease from separate multicenter trials of 30 Units/kg and 60 Units/kg doses infused every 2 weeks.

eSource Records in Clinical Research: Keeping it Simple

April 15, 2015

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Data Management
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Article

The benefits of eSource data: collecting data digitally without having to record the data on a piece of paper first.

The Impact on Clinical Research Sites When Direct Data Entry Occurs

October 1, 2014

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Data Management
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Article

In 2010, the European Medicines Agency (EMA) issued a “Reflection Paper Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials,” and in 2013, the United States Food and Drug Administration (FDA) issued the “Guidance for Industry: Electronic Source Data in Clinical Investigations”. These documents support the concept of the use and acceptance of eSource documents in lieu of paper records by regulatory agencies.

Three-Pronged Approach to Optimizing Trial Monitoring

Study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry.

Pushing For Paperless Clinical Trials

July 1, 2014

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Software
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Article

Colleagues who have been collaborating with Dr. Mitchel over the past 20 years or so say he is tireless in his work to create and champion a paperless clinical trial platform database.

Form FDA 483 - Myths and Misunderstandings

April 1, 2014

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Regulatory
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Article

Nobody wants to receive a Form FDA 483 after an FDA inspection of a clinical site, drug/device company, manufacturing plant or other entities subject to regulatory inspections. Nevertheless, while inspection findings are inevitable, they are not intended to be "the end of the world."

Time to Change the Clinical Trial Paradigm

January 14, 2014

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CRO
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Article

Results from a multi-center clinical trial using a quality by design methodology, risk-based monitoring and real-time direct data entry.

Barriers to Change: Value Proposition of eSource

January 2, 2014

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Data Management
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Article

Some of us may be curious and adventuresome, while some of us are not; and that is okay. Some say “if it ain’t broke why fix it” and put off decisions until a crisis hits. While some crises are predictable and others seem to happen by chance, unfortunately, crises can be catastrophic and lethal, or at a minimum, require energy and resources to reverse.

21st Century Approaches to QA Oversight of Clinical Trial Performance

December 1, 2013

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CRO
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Article

Describing a drug development program initiated using a quality-by-design approach, with special attention paid to assuring proactive quality planning at all stages of development.

Insider Insights: Target Health Inc.

October 28, 2013

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CRO
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Article

CWWeekly’s semi-monthly company profile feature, Insider Insights, interviews executives of companies and organizations in the clinical trials space. Writer Ronald Rosenberg sat down with Jules T. Mitchel, Ph.D., president of Target Health.

Risk-Based Approaches

The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.

How Direct Data Entry is Transforming Clinical Research

With the advent of today’s online world, from web-based banking to plane reservations to shopping, it makes little sense for clinical research sites to collect patient data on a piece of paper and then transcribe the data to an electronic data capture (EDC) system.

Lessons Learned From Direct Data Entry

July 4, 2012

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CRO
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Article

In order to assess the impact of direct data entry (DDE) on the clinical trial process, a single-site, phase 2 clinical trial, under a US investigational new drug application (IND), was performed where the clinical site entered each subject’s data into an electronic data capture (EDC) system at the time of the office visit and the clinical research team implemented a risk-based monitoring (RBM) plan.

Time for Change

February 1, 2012

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Software
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Article

Jules T Mitchel and Judith M Schloss Markowitz at Target Health Inc. explain how risk-based monitoring and direct data entry will transform clinical trials.

A Novel Enzyme Replacement Therapy for Gaucher Disease

November 1, 2011

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Regulatory
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Article

Target Health, Inc. participated in study design, regulatory activities, and data management, and reviewed all versions of the manuscript for this clinical trial.

Monitoring the Quality of Conduct of Clinical Trials

A variety of quality assurance (QA) procedures are typically implemented to ensure that clinical trial are carried out as designed, that good clinical practices (GCP) and regulations governing the conduct of trials are followed, and that data used to assess treatment effects are accurate and complete.

Evaluation of Data Entry to an Electronic Data Capture Clinical Trial Database

Monitoring of clinical trials includes several disciplines, stakeholders, and skill sets. The aim of the present study was to identify database changes and data entry errors to an electronic data capture (EDC) clinical trial database, and to assess the impact of the changes.

The High Cost and Questionable Impact of 100% SDV

February 1, 2011

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Data Management
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Article

It is rare for the clinical trials industry to spend time and money on a tedious and labor intensive process when it is not required by the U.S. Food and Drug Administration (FDA). But that’s exactly what is happening with source data verification.

Risk-Based Source Data Verification Approaches: Pros and Cons

November 1, 2010

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Data Management
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Article

The high cost of source data verification (SDV), particularly in large trials, has made it a target of scrutiny over the last decade. In addition, the positive impact (ie, cost-benefit ratio of SDV) on overall data quality is often questioned. As a result, regulators and industry groups have started looking at alternative SDV approaches.

How Electronic Data Capture (EDC) Can Be Integrated

October 1, 2010

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Data Management
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Article

Oversight of the clinical trials includes clinical research, data management, biostatistics, project management, regulatory and quality assurance. One of the goals of monitoring of clinical trials is to have accurate data for the analysis of efficacy and safety.

The Final eFrontier

Historically, clinical trial data were collected at the clinical research site on pieces of paper designated as Source Documents. These data were transferred manually by the site to paper case report forms (CRFs), which were then monitored against source documents by CRAs to basically see how accurately information could be copied from one piece of paper to another.

Electronic Medical Records: The Future is Here or Is It?

Sometimes it seems as if we've been discussing electronic medical records (EMRs) forever. Those of us in the healthcare trenches, whether physicians, patients, employers, payers or government officials, can easi Iy be forgiven for having more than a dollop of cynicism about the current enthusiasm about the adoption of EMRs.

EDC Co-Development a Win-Win for Ferring, Target Health

Common wisdom holds that drug makers should stay out of the business of developing information technology (IT) software and instead buy one of the many proven, off-the-shelf solutions. But that’s not necessarily the best and cheapest way to collect data or manage clinical trials.

End of the Paper Trail

December 1, 2008

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Data Management
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Article

Jules Mitchel and Irene Ghilezan at Target Health, Inc, and Thersa Luna and Susan Carroll at Prometheus Laboratories, and Aida Bibliowicz at Cato Research Ltd, feel that turning away from our love for paper is the best way to optimize clinical trials.

The Other Life-Sciences Industry

October 31, 2008

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CRO
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Article

Mention medical devices and diagnostics (MD&D) and most life scientists think of surgical instruments, catheters, prosthetic limbs, artificial joints, and imaging machines. Yet, recent advances in genomics and bioinformatics, coupled with nanotechnology and innovations in the biomaterials field, are transforming the MD&D industry.

Paperless Push at Target Health

August 7, 2008

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CRO
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Article

Jules Mitchel might be a good source to consult if you doubt the continents of services and technology are tectonically colliding. With his wife, Joyce, Mitchel runs Target Health, a small New York contract research organization (CRO) that has always been keenly interested in building its own technology—both for the sake of internal efficiency and for what customers can do with it. Business sounds good.

The Impact of Electronic Data Capture on Clinical Data Management

With the proper Electronic Data Capture toolbox, the clinical group may now be able to deploy a full EDC study in days rather than weeks or months.

Data Management in Oral Health Research

January 1, 2008

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Data Management
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Article

Good data management practice (GDMP) promotes the collection of quality data and facilitates meaningful data analysis.

The Critical Path Initiative Meets Medical Device

March 1, 2007

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Regulatory
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Article

Interaction is high on FDA’s list of ways to improve the development and review process for technologies.

The Paperless Trial - Past, Present and Future

January 1, 2007

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Data Management
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Article

The technology is ready and available.What the industry is waiting for are the innovators, trailblazers and ‘risk-takers’ to take the plunge. The pharmaceutical industry has reached a fork in the road.There will be those who will choose to stay where they are in the short term, and there will be those who will embrace the integration of EHR and EDC systems.

The Role of CRAs in Internet-based Clinical Trials

August 1, 2006

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CRO
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Article

The goal of this paper is to describe what new career opportunities are now available to CRAs with the advent of Internet-based clinical trials.

Impact of IBCTs on Clinical Trial Efficiency

August 1, 2006

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Data Management
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Article

This case study shows how Internet based clinical trials improve data entry, monitoring, and management.

Web-Based CRF Saves Wellspring 30 Percent Over Paper Records

October 1, 2004

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Software
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Article

To optimize clinical development, WellSpring turned to Target Health to provide an Internet-based electronic case report form (CRF) without having to supply software to each study site. There was immediate cost savings of 30 percent from a paper trial.

Target Health: A New Tool

September 30, 2004

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CRO
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Article

Target Health is a good example of a company that defies categorization. With 22 employees, a fifth of whom are software developers, it is a small contract research organization (CRO) in Manhattan. But Target also develops its own commercial-grade applications for electronic data capture (EDC), as well as clinical data and trial management.

Meeting the Challenges of Internet-based Clinical Trials

June 1, 2004

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Software
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Article

In addition to new efficiencies, Internet based clinical trials introduce new responsibilities for clinical research teams and investigators alike.

Changing Roles When Implementing Internet-Based Clinical Trials

November 1, 2003

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Software
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Article

One of the most difficult parts of implementing Internet-based Clinical Trials, has nothing to do with the fundamental technology, but rather with making the necessary changes in structure, mind-set and culture within the sponsoring company as well as the clinical study sites. Choosing the right people to manage and execute the process is key to the success of any program.

An Interview with Jules Mitchel

September 1, 2003

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CRO
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Article

Dr Mitchel speaks with CW Weekly on CROs adoption of EDC, taking Target Health 100% eClinical, and the challenges involved with that decision.

Using Internet Technology to Collect Reliable Data

Electronic data capture can be invaluable to speed clinical development processes. A recent study demonstrates the reliability of data collected by this method.

Internet-Based Clinical Trial- Practical Consideration

January 1, 2003

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Software
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Article

By reducing data entry errors through the use of online edit and logic checks in clinical trials, there is improved data quality as well as a reduction in the time to database lock.

Paper vs. Web; A Tale of Three Trials

August 1, 2001

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Software
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Article

A comparison of a paper-based study with two Web-based ones shows how Web technology can save sponsors money.

FDA Relations During Drug Development

September 14, 2000

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Regulatory
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Article

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs.

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