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  September 2010

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Life Sciences Summit Meeting on September 25 and 26, 2010

Target Health is pleased to announce that Dr. Jules Mitchel will be moderating a Business Workshop at the Life Sciences Summit being held this year at the Hyatt Regency 1717 Motor Parkway, Hauppauge, New York, 11788 on September 25 and 26, 2010.

The workshop is entitled: “Successful Product Development: A Practical Guide to Doing It Right.” Our panelists include:

1. Richard Clark, MD, Professor at SUNY Stony Brook School of Medicine and has just set up a company with technology he developed

2. Braham Shroot, PhD, CEO of Signum Biosciences and former CSO at Barrier Therapeutics

3. Henry Pan, MD, PhD, CEO of Renascions and Pan Consulting Associates LLC and former EVP at DuPont Merck and VP of Clinical R&D at BMS.

4. Mark Horn, MD, MPH, worked in licensing at Pfizer for 5 years and current CMO at Target Health

For more information about Target Health contact Warren Pearlson (212-681-2100 ext 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website. 

New Publication – How Electronic Data Capture (EDC) Can Be Integrated Into The Data Monitoring Plan (DMP)

Target Health is pleased to announce that an article entitled “How Electronic Data Capture (EDC) Can Be Integrated Into The Data Monitoring Plan (DMP)“ has been accepted for publication by the Society for Clinical Data Management. If you would like a copy, please contact  Dr. Jules T. Mitchel. For other publications by Target Health, please visit our website.

For more information about Target Health contact Warren Pearlson (212-681-2100 ext 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website. 

New York Times Front Page News – 14 August 2010

Target Health wants to congratulate Dr. Erin Gainer, CEO of HRA Pharma, Paris, on the approval of ella™ (ulipristal acetate) tablets for emergency contraception (See FDA below) and for reaching the front page of the New York Times this past Saturday. The product has been available in Europe under the brand name ellaOne.

Target Health is pleased to be a partner of this project since 2006. Target Health was the US FDA Agent for this program and performed the statistical analysis for both pivotal trials as well as the integrated summary of safety (ISS) and efficacy ISE). In addition, we performed monitoring for one of the pivotal trials and wrote both of the clinical study reports.  Target e*CRF^® was used for the pivotal trials performed in the US and Europe. This is the 19^th product approved that used Target e*CRF for pivotal trials.

For more information about Target Health contact Warren Pearlson (212-681-2100 ext 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

Dr. Mitchel to Present at ACRP Panel at NYU Medical Center

Target Health Inc. is pleased to announce that Dr. Jules T. Mitchel will be participating in a panel entitled “IT (Information Technology) Compliant Centers; Part 11 Compliant, EMR, eCRF.” at the ACRP New York Metropolitan Chapter Fall 2010 Symposium entitled, “Site Excellence in Clinical Research.” This two-day event will take place on Friday September 24^th and Saturday September 25th at New York University Medical Center. Dr. Mitchel’s topic will be “The Integration of Electronic Data Capture (EDC) with the Electronic Clinical Trial Record (eCTR) and Electronic Medical Record (EMR).” Other panel members include:

1. Victoria Spendel – Cincinnati Children’s Hospital Medical Center
2. Lisa Weiss – Shire Pharmaceuticals
3. Jaimie Lucove – Allscripts

Please let us know if you will be attending.

For more information about Target Health contact Warren Pearlson (212-681-2100 ext 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

Target Encoder Version 1.4 Being Released This Month

 

Target Health Inc. is pleased to announce that Target Encoder™ Version 1.4 is being released this month. Target Encoder is fully web-based and has been developed with several of our top EDC clients to facilitate their ability to code to MedDRA and WHO DRUG when using Target e*CRF^®. Target Encoder Version 1.4 has many new features and is not limited to Target e*CRF EDC users.

Target Health is committed to provided cost effective and user-friendly software to our CRO partners and the pharmaceutical industry. Target Health software products include Target e*CRF, Target Document^®, Target Encoder, Target e*CTMS^®, Target Newsletter™ and Target e*CTR^®, the eClinical Trial Record.

For more information about Target Health contact Warren Pearlson (212-681-2100 ext 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health website at: www.targethealth.com

Target Health and LifeOnKey EHR and EDC Collaboration

 

Target Health Inc., and LifeOnKey Inc., are pleased to announce the development of an alliance to provide an innovative fully integrated information system for Phase 1 to Phase IV clinical research services to the biopharmaceutical and device industry, including the electronic health record (EHR), Personal Health Record (PHR), and Registries fully integrated with electronic data capture (EDC) software. This partnership takes advantage of the extensive expertise in the development of innovative information systems residing in both companies in order to successfully and efficiently move products to the market.

“We are very enthusiastic about building a comprehensive solution for the integration of clinical trial software and EHRs for the industry,” comments Target Health Inc. President Dr. Jules Mitchel. “With over 17 years of clinical trial and clinical trial information systems developed and implemented at Target Health, coupled with the state-of-the-art Health Management Platform offered by LifeOnKey, this partnership is the first of its kind in the field of Clinical Trials and Post Marketing Surveillance.”

“LifeOnKey is joining forces with Target Health to bring to the market the first integrated system to enable clinical research to be part of the revolution in health information systems, and that LifeOnKey’s vast experience and know-how in health information systems compliments the outstanding product development expertise of Target Health,” explains Dr. Linda Harnevo, CEO of LifeOnKey.

For more information about Target Health contact Warren Pearlson (212-681-2100 ext 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health website at: www.targethealth.com

Software Releases This Summer

Target Health will be releasing 3 software products this Summer:

• Target Document^® Version 1.6 allows any company to run a paperless operation. This 21 CFR Part 11 compliant software allows for eSignatures, multiple document upload and download, paperless Trial Master File (TMF), bulletin board, etc. Both Pharma companies and CROs have licensed the software.

 

• Target Encoder^® Version 2 allows for the rapid encoding of MedDRA and WHO DRUG terms, maintenance of user defined dictionaries and full integration with any SQL database. This 21 CFR Part 11 compliant software is fully integrated with Target E*CRF^®.

 

• Target eCTR^® Viewer Version 1, a 21CFR Part 11 compliant software, allows for viewing eSource documents from any EDC system. Target e*CTR has already been integrated with an Electronic Medical Record for full EMR/EDC integration. There will be a press release on this partnership shortly.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health             website at:

www.targethealth.com

Clinical Trial Transformation Initiative (CTTI)

Target Health has been a member of the Steering Committee of Clinical Trial Transformation Initiative (CTTI) beginning in 2008. The mission of CTTI is “To identify practices that through broad adoption will increase the quality and efficiency of clinical trials.” Currently, over 50 organizations comprise CTTI, including government agencies (the FDA, Centers for Medicare and Medicaid Services (CMS), Office of Human Research Protections (OHRP), National Institutes of Health (NIH), and other national and international governmental bodies), industry representatives (pharmaceutical, biotech, device, and CROs), patient and consumer representatives, professional societies, investigator groups, academic institutions, and other interested parties. One of the projects CTTI has championed is the monitoring of clinical trials. A poster was presented at the 2010 Annual Meeting of the Society of Clinical Trials entitled “A CTTI Survey of Current Monitoring Practices.” A manuscript will be published shortly. Let us know if your company would be interested in joining. It is a stellar group of people.

For more information about Target Health contact Warren Pearlson (212-681-2100 ext 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health website at:

www.targethealth.com

New Readers

ON TARGET welcomes our new readers who met us this month at the annual meeting of the Drug Information Association (DIA) in Washington and at BioMed in Israel. ON TARGET has been published continually since 1995 and there are now over 3,200 loyal readers who receive ON TARGET by request only. Readers are from Industry, Government, Academia and those who just want to read something interesting each week. The mailing list is never shared with anyone and is housed in a secure environment with the Target Health IT Department.

For more information about Target Health contact Warren Pearlson (212-681-2100 ext 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health website at: www.targethealth.com

Good Week for Target Health Clients – EDC Approval for an HIV Diagnostic and Panel Approval for ellaOne

Target Health is pleased to announce the PMA approval of Abbott ARCHITECT HIV Ag/Ab Combo, which is indicated as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. Target e*CRF^® was used for this program and the PMA was approved in 6 months. This is the 19th unique product that has been approved by FDA/EMA that used Target e*CRF for EDC. Two other drug approvals are expected this year.

Target Health congratulates HRA Pharma for the unanimous advisory panel approval of ulipristal acetate (ellaOne) for the treatment of emergency contraception. For this program, Target e*CRF® was used for the two pivotal trials.  Target Health monitored one of the pivotal trials performed in the US and performed the statistical analyses.  Target Health wrote the study reports and was the FDA agent for the IND. The committee’s vote followed a review of data from the preclinical program and the clinical development program involving more than 4,000 women from the U.S. and Europe. Ulipristal acetate was approved in May 2009 by the European Commission.

For more information about Target Health contact Warren Pearlson (212-681-2100 ext 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health website at: www.targethealth.com

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