UPDATE FROM TARGET HEALTH INC.

Highlights of the Last 12 Months

We would like to thank the loyalty and feedback of our over 4,600 readers, some of whom have been receiving ON TARGET since 1995.

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View from Target Health’s 24th Floor © Jules T. Mitchel 2013

 

Several times a year we are asked what Target Health does and what are our accomplishments. The following summarizes what has happened over the last 12 months.

 

On May 25, 2013, Target Health celebrates its 20th year as a New York City-based, full-servicee*CRO with full-time staff dedicated to all aspects of the paperless clinical trial complementing our expertise in Drug and Device Regulatory Affairs and Strategic Planning, Clinical Research Management, Biostatistics, Data Management, Internet-based clinical trials (Target e*CRF®), Medical Writing, and Strategic Planning.  We also provide fully validated software for clinical trials. Our mission is to serve the pharmaceutical, biologics and device communities through knowledge, experience, technology and connectivity. We strive to optimize the life cycle of product development with expertise, leadership, innovation and teamwork.

 

Highlights of the last 12 months include:

 

A.  Major Contributions to the Approval of Drug Products for the Following Indications:

 

1.  Gaucher disease (FDA)
2.  Head lice (FDA)
3.  Exocrine pancreatic insufficiency (FDA)
4.  Debridement of eschar in 3rd degree burns (EMA)

 

B.  Implementation of 11 Paperless Clinical Trials Under 3 US INDs:

 

1.  Men’s health (7 studies)
2.  Topical antimicrobial (2 studies)
3.  Phase 1 safety (2 studies)

 

C.  Steering Committee Memberships

 

1.  Clinical Trial Transformation Initiative (CTTI)
2.  Multi-Regional Clinical Trial Center (MRCT) – Harvard Global Health Institute

 

D.  Publications

 

1.  Mitchel, J and Schloss Markowitz, JM. Risk Based Monitoring, Time For Change – International Clinical Trials, International Journal of Clinical Trials February 2012
2.  Mitchel, J, Schloss Markowitz, JM. Yin, Hua (Helen) et al.  Lessons Learned From a Direct Data Entry Phase 2 Clinical Trial Under a US IND – DIA Journal, Drug Information Journal 2012 46:464-472
3.  eClincal Forum Task Force. Risk Based Approaches – Best Practices for Ensuring Clinical Data Quality. Applied Clinical Trials 2013 (Accepted for publication)

 

E.  Software Upgrades

 

Target e*CTR™ v 1.1 (electronic health record for clinical trials)
Target e*Studio® v 1.2 (generates Target e*CRF EDC applications
Target Document® v 1.6 (eTMF document management)
Target e*CTMS™ v 1.3 (Clinical trial management system)
Target e*Pharmacovigilance™ v 1.0 (Safety monitoring and generation of 3500A and CIOMS 1 Forms)
Target Encoder® v 1.3 (MedDRA and WHO Drug coder)

REGULATORY AFFAIRS

Target Health now represents over 30 companies at FDA from all over the world includingDenmark, England, France, Germany, Israel, Sweden, Switzerland and the US.

DEVELOPMENT PROGRAMS

a. Bladder cancer
b. Cancer imaging
c. Cardiology
d. Colorectal cancer
e. Counterterrorism
f. Dermatology
g. Fabry disease
h. Fatty liver
i. Gaucher disease
j. Hypogonadism
k. Ovarian cancer
l. Pancreatic cancer
m. Rheumatology
n. Somnolence
o. Traumatic brain injury
p. Ulcerative colitis
q. Vaccines
r. Wound Healing

FDA Meetings

Counterterrorism

Men’s Health

Somnolence

Electronic Submissions

Target Health has expertise in preparation and publishing of electronic submissions and is an FDA approved vendor for electronic submissions through the Electronic Submissions Gateway (ESG).

CLINICAL TRIAL SOFTWARE PACKAGES

Target eClinical Trial Record (Target e*CTR®): Target e*CTR allows the clinical study sites to perform direct data entry into any EDC system, and at the same time generates a read-only electronic document, which can be designated as the primary source data (eSource). These data, maintained in a secure, read-only trusted 3rd party environment, are available to the clinical study sites, monitors and regulatory agencies in a human readable format.

Target e*CRF®: Target e*CRF has now been used in over 250 clinical trials since 1999. Target e*CRF is now fully integrated with onsite and central monitoring reports, risk-based monitoring reports, 3500A and CIOMS reports, as well as Target Encoder.

Target e*Studio®: Target e*studio allows users to build Target eCRF applications using a technology transfer business model.  This software has been designed to minimize the use of programmers and allows the build and release of EDC applications in 1-2 weeks

Target Document®: Target Document is a user-friendly, inexpensive; highly sophisticated, Web-based, document management system that allows authorized users to view, download, and manage any document for their organization. – No More paper – Target Document can be used for the eTrial Master File (eTMF) and features include: 1) 21 CFR Part 11 compliance; 2) routing for electronic signatures; 3) email alerts; 5) communication tools.

Target Encoder®: Target Encoder is a user-friendly, inexpensive; highly sophisticated, Web-based, coding system that allows authorized users to automatically code MedDRA and WHO Drug and other types of dictionaries.  Target Encoder is fully integrated with Target e*CRF.

Target e*Pharmacovigilance®: Target e*CRF integrates EDC with a pharmacovigilance module by 1) allowing the principle investigators to enter a narrative, 2) allowing the medical monitor to enter a narrative and then have the EDC system generate an approved version of Form 3500A or CIOMS for regulatory submission with the ability to control the original and followup submissions.

Target e*CTMS®:  Target e*CTMS is a user-friendly, inexpensive; highly sophisticated, Web-based, clinical trial management system. A new clinical trial starts with identification of the sponsor and project name.  Investigators, IRBs and users are maintained within the CTMS and can be easily assigned to a project.  All staff within a clinical site can be identified with their title and contact information, as well as shipping addresses which could be different from the head office.  As the site commits to participate in the clinical trial, a site number can be assigned.  Once IRB approval is obtained, and all regulatory documents have been identified as received, an alert can be sent out via email to allow for drug shipment.  Target e*CTMS provides many additional features such as: 1) Decision Logs, 2) Meeting Logs with uploading of the meeting minutes, 3) Questions and Answers, 4) status of Regulatory Submissions and Deliverables, and 5) Monitor Site Visit Tracking with document upload.

Target Batch Edit Checks: With Target e*CRF®, batch edit checks are now integrated with the electronic query system within the study.  Target e*CRF® runs the edits and displays the results of those edits through a discrepancy review screen integrated with the query system.

ACADEMIC COLLABORATIONS

EDC vendor for 2 NIH grants in Juvenile Rheumatoid Arthritis at the Cleveland Clinic andUniversity of Washington.  Collaboration with the Biotechnology Center at SUNY Stony Brook, Rutgers and UMDNJ (the Medical School of New Jersey) and NY Medical College.

Dr. Mitchel is a Course Director at the Center for Biotechnology, Fundamentals of the Bioscience Industry, SUNY Stony Brook School of Medicine.

INDICATIONS

3rd degree burns Dermatology Menopausal symptoms
Adhesion prevention Emergency contraception Nocturia
Atopic dermatitis Erectile dysfunction Osteoporosis
Bladder cancer Gaucher’s disease Ovarian cancer
Bone fractures Growth Impairment Pancreatic cancer
Brain Imaging Hereditary angioedema Pre-eclampsia diagnostic
Cardiac implant device Head lice Prostate cancer
Cardiology diagnostic Hemostasis Scleroderma
Colorectal cancer HIV diagnostic Transdermal drug delivery
Cushing’s disease Infertility Ulcerative colitis
Cystic fibrosis Juvenile rheumatoid arthritis Wound Healing

Target Health (www.targethealth.com) a full service e*CRO, is committed to serve the pharmaceutical community through knowledge, experience, technology and connectivity. Target Health strives to optimize the life cycle of drugs, biologics and devices with expertise, leadership, innovation and teamwork. Target Health Inc. has fulltime staff dedicated to all aspects of Regulatory Affairs, Clinical Research, Biostatistics, Data Management, Strategic Planning and Drug and Device Development. Target Health is committed to the paperless clinical trial and has developed a full suite of eClinical Trial software including:

1) Target e*CRF® (EDC Made Simple)

2) Target e*CTMS™

3) Target Document®

4) Target Encoder®

5) Target e*Pharmacovigilance™

6) Target e*Monitoring™

7) Target Newsletter®

8) Target e*CTR™ (eSource, electronic medical record for clinical trials).

Target Health’s Pharmaceutical Advisory Dream Team assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.

TARGET HEALTH INC.
261 Madison Avenue
24th Floor
New York, NY 10016
Phone: (212) 681-2100; Fax (212) 681-2105

http://blog.targethealth.com
www.targethealth.com
Ms Joyce Hays, CEO
Dr. Jules T. Mitchel, President

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