Selecting Partners in Countries or geographic areas where it has no existing Infrastructure.
The FDA and other regulatory bodies have issued multiple guidance documents addressing technology tools that are used in clinical trials.
The following are points to consider when designing and using an electronic informed consent form (eICF).
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.
Dr. Jules Mitchel at Disruptive Innovations in Boston, September 20, 2016
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.
The Society for Clinical Research Sites (SCRS), the trade organization representing over 2,600 global clinical research sites in 42 countries, announces today the finalists for the 2015 SCRS Eagle Award.
Dr. Jules Mitchel shares what it's like being an inspiration to the industry, how he inspires his team and peers, who has inspired him, and the innovations he is seeing in the industry.
PharmaVOICE interview with Dr. Jules Mitchel, the Commander in Chief of Target Health, Inc.
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.
Dignitana AB announced that the company has submitted for review an application to the US Food and Drug Administration (FDA) Center for Devices and Radiologic Health for approval of the DigniCap™ System. Dignitana engaged the Clinical Research Organization (CRO) Target Health Inc., with offices in New York, in 2011, and Dignitana has been working in close collaboration with Target Health to interact with FDA, conduct the pivotal clinical trial and prepare the FDA application.
Working with FDA: How creative one can be when working with FDA to optimize the drug and device development process.
Results from a multi-center clinical trial using a quality by design methodology, risk-based monitoring and real-time direct data entry.
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.
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.
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.
Slides from Society for Clinical Trials, The goal of this CTTI-sponsored project was to describe current clinical monitoring methods for a range of clinical trial types, and to explore the rationale for the use of those methods.
The goal of this CTTI-sponsored project was to describe current clinical monitoring methods for a range of clinical trial types, and to explore the rationale for the use of those methods.
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.
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.
CytoDyn, Inc. (Pink Sheets:CYDY) has selected Target Health, Inc. for the preparation and electronic filing of CytoDyn’s upcoming FDA application using Target Health’s proprietary e*CRF® system.
"This alliance delivers us immediate speed and efficiency to our drug development efforts resulting in quality clinical trial data at high levels of regulatory compliance," stated Tom Davis, arGentis' Chief Executive Officer. "Target Health's proven track record of NDA and PMA approvals verifies that we will be able to accrue valuable clinical study performance through enhanced planning and achieve favorable end points to our trials."
Three human studies, including 167 subjects, were designed to demonstrate the safety, efficacy and minimum effective dose of the Summers L.A. product.
Overall survival and other efficacy parameters show efficacy compared to historical controls, suggesting further study of micellar paclitaxel for the treatment of pancreatic cancer.
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.
Implementing and executing a G-IBCT, presents new challenges to the pharmaceutical industry, and will require some reengineering of a company’s clinical research and data management processes.
Global, internet-based clinical trials (G-IBCTs) can offer convenient, cost-effective solutions for the streamlining aspects of the clinical research process.
The rationale for the use of an internet-based clinical trial to obtain safety, pharmacokinetic and pharmacodynamic data in dose escalation study in neonates, with hyperbilirubinemia, who need exchange transfusion.
In order to speed up the process of data retrieval and evaluation, a specific Internet-based electronic data capture module was developed for pharmacokinetic and pharmacodynamic studies, allowing for rapid data entry, viewing and monitoring.
The use of Internet-based clinical trials can provide rapid access to clinical trial data, improve data quality and provide dramatic cost savings.
Global, internet-based clinical trials (G-IBCTs) can offer convenient, cost-effective solutions for the streamlining aspects of the clinical research process.
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.
The presentation will include a demonstration of this new technology, some cost and benefit factors, hints on implementing new programs, examples on how to gather and interpret data, and how to make FDA a partner in the process.
The use of Internet-based clinical trials in single-center studies, such as a 200-subject sensitization/irritation study, and in multicenter studies such as acne, psoriasis and atopic dermatitis, can provide rapid access to clinical trial data as well as improved quality and dramatic cost savings.
Dr Mitchel speaks with CW Weekly on CROs adoption of EDC, taking Target Health 100% eClinical, and the challenges involved with that decision.
Many drugs which have been evaluated for oral use may also have applications as topical therapies. As part of the “discovery” phase of drug development, companies interested in topical drug therapy should examine their libraries to identify drugs which already have toxicology and clinical data.
Dermatology provides an unmet need for drug development. There are two reasons to develop drugs for topical use. The first is to treat skin diseases and disorders such as psoriasis, acne, actinic keratosis, cancer, eczema, etc. These conditions represent some of the most common and chronic disease states in man. The second reason is to deliver systemically active drugs through the skin to enhance drug activity by, 1. avoiding first pass metabolism, 2. reducing toxicity and 3. improving compliance.
The present study was designed to determine the effects of oral administration of the nitric oxide-precursor Larginine, in combination with the alpha2 blocker yohimbine, on subjective and physiological (vaginal photoplethysmography) responses to erotic stimuli in postmenopausal women with Female Sexual Arousal Disorder (FSAD).
There is often a relatively large gap of time, between the time clinical trial data are collected and the time they are viewed and analyzed. In order to speed up the process of data retrieval, a specific Internet-based electronic data capture module has been developed for pharmacokinetic and pharmacodynamic studies, which allows for rapid data entry and monitoring.
The objective of this study was to evaluate the economics of performing Internet-based clinical trials, looking specifically at query management.
When technically feasible, topical delivery of drug products, both for local and systemic use, may offer advantages over the oral route.
This paper reviews laboratory and clinical data concerning oral phentolamine mesylate, Vasomax, an alpha-1, alpha-2 adrenergic receptor antagonist developed specifically for treatment of erectile dysfunction.
When technically feasible, topical delivery of drug products for both local and systemic indications offer many advantages over the oral route.
The objectives of this pilot study were to evaluate the efficacy and safety of 3 doses of topical alprostadil USP (prostaglandin E1) cream in comparison with placebo in 8 female patients with sexual dysfunction.
Joe Lombarino presents the story of the Feldene, and then contrasts that story with pharmceutical research and development as it is practiced today.
This is a video of a lecture from New York Biotechnology Association by Target Health’s own Al Alberts, formerly of Merck.
