UPDATE FROM TARGET HEALTH INC. – HIGHLIGHTS OF THE YEAR
We would like to thank the loyalty and feedback of our over 4,300 readers, some of whom have been receiving ON TARGET since 1995. 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.
In 2012, Target Health celebrated its 19th year as a New York City-based, full-service e*CRO. Our full-time staff are dedicated to all aspects of the “paperless clinical trial,” complementing our expertise in Drug and Device Regulatory Affairs, Clinical Research Management, Biostatistics, Data Management, Internet-based clinical trials (Target e*CRF®), Medical Writing, and Strategic Planning. We provide turn-key development operations for small and medium size companies and have fully validated software for clinical trials. Patent # 8,041,581 B2 was issued in October 2011 for a System and Method for Collecting, Processing, and Storing Discrete Data Records Based Upon a Single Data Input (Target e*CTR®; eClinical Trial Record).
Highlights of the last 12 months include:
1. Regulatory approval of 3 NDAs and 1 PMA
a. Gaucher disease – May 2012
b. Cystic Fibrosis – May 2012
c. Head Lice – February 2012
d. Companion Diagnostic for NSCLC Drug – August 2011
2. Implementation of 3 paperless eSource clinical trials under 2 US INDs, using Target eCTR® (eClinical Trial Record; patent issued), the “electronic health record” for clinical trials
a. Mitchel, J, Kim, YJ, Choi, JH, et al. Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture (EDC) Clinical Trial Database. Drug Information Journal, 2011, 45:421-430.
b. Morrison, B, Cochran, C, Giangrande, J, et al. Monitoring the quality of conduct of clinical trials: a survey of current practices. Clinical Trials, 2011; 8:342–349.
c. Mitchel, J. and Schloss-Markowitz, J. Time for Change. International Journal of Clinical Trials, February 2011; 22-29.
d. Tantsyura, V., Grimes, I., Mitchel, J. et al. Cost-Effective Approach To Managing Laboratory Reference Ranges For Local Laboratories, DIA Journal (2012, in press)
e. Mitchel, J., Schloss-Markowitz, J., Yin, H. Lessons Learned From a Direct Data Entry (DDE) Phase 2 Clinical Trial Under a US IND. DIA Journal (2012, accepted for publication)
4. Three original IND submissions
5. Target Health member of the CTTI Steering Committee
6. Release of:
a. Target e*CTR® v 1.2 (electronic health record for clinical trials; Patent # 8,041,581 B2)
b. Target e*Studio® v 1.1 (generates Target e*CRF EDC applications
c. Target Document® v 1.6 (eTMF document management)
d. Target e*CTMS™ v 1.3 (Clinical trial management system)
e. Target e*Pharmacovigilance® v 1.0 (Safety monitoring and generation of Form 3500A and CIOMS 1)
f. Target Encoder® v 1.3 (MedDRA and WHO Drug coder)
g. Target Monitoring Reports™ v 1.0 (online monitoring reports)
We are also very pleased to announce that Target Health has played a key role in bringing to market 35 new drug or device products. Of these approvals, there are now 25 products marketed world-wide that used Target e*CRF for their pivotal trials:
- NDA pancreatic Insufficiency – Cystic Fibrosis – Monitoring; DM; Statistics; Writing; NDA Preparation
- NDA – Gaucher Disease – EDC ; Regulatory Consulting, Toxicology, Monitoring; DM; Statistics; Writing, NDA, eCTD
- PMA – Companion Diagnostic – EDC
- NDA – Head Lice – EDC
- NDA/MAA – Hereditary Angioedema –Regulatory Affairs, EDC
- NDA Emergency Contraception –- EDC ; Regulatory Affairs, Monitoring; DM; Statistics; Writing
- NDA/MAA – Prostate Cancer – EDC
- NDA – Head Lice– EDC; Toxicology, Regulatory Consulting, Monitoring; DM; Statistics; Writing; NDA (eCTD)
- BLA – Autoinflammatory Disease – EDC
- NDA/MAA – Infertility – EDC ; DM; Statistics
- NDA/MAA – Infertility – EDC; DM; Statistics
- PMA – Periodontal Disease – GEM 21S (Biomimetic Therapeutics) – EDC; Monitoring; DM; Statistics; Writing
- Canada – Bone Fractures – GEM 21S (Biomimetic Therapeutics) – EDC; Monitoring; DM; Statistics; Writing
- PMA – Surgical Adhesions – REPEL CV (Synthemed, Inc. Approvable) – EDC; Monitoring; DM; Statistics; Writing; PMA (eCopy)
- PMA – Ten (10) Diagnostic Approvals (Abbott Laboratories) – EDC
- 510(k) – One (1) Diagnostic Approval (Abbott Laboratories) – EDC
Target Health now represents over 30 companies at FDA from all over the world including England, France, Germany, Israel, Korea, Switzerland and the US.
i. Bladder cancer
ii. Colorectal cancer
iii. Cancer imaging
iv. Ovarian cancer
v. Pancreatic cancer
b. Orphan Disease
i. Gaucher disease
ii. Cystic fibrosis
iv. Growth hormone
f. Fatty liver
i. Traumatic brain injury
j. Ulcerative colitis
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 e*CRF®: Target e*CRF (EDC) has now been used in over 250 clinical trials since 1999. Largest trial to date is over 7,000 patients.
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*Studio®: Target e*studio allows users to build Target eCRF applications using a technology transfer business model.
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*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.
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.
EDC vendor for 2 NIH grants in Juvenile Rheumatoid Arthritis at the Cleveland Clinic and University of Washington. Collaboration with the Biotechnology Center at SUNY Stony Brook, Rutgers and UMDNJ (the Medical School of New Jersey).
Dr. Mitchel is a Course Director for Center for Biotechnology, Fundamentals of the Bioscience Industry, SUNY Stony Brook School of Medicine.
1. Mitchel, J, Kim, YJ, Choi, JH, et al. Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture (EDC) Clinical Trial Database. Drug Information Journal. 2011, 45:421-430.
2. Morrison, B, Cochran, C, Giangrande, J, et al. Monitoring the quality of conduct of clinical trials: a survey of current practices. Clinical Trials, 2011; 8:342–349.
3. Mitchel, J. and Schloss-Markowitz, J. Time for Change. International Journal of Clinical Trials, February 2011; 22-29.
4. Tantsyura, V, Grimes, I, Mitchel, J. et al. Cost-Effective Approach to Managing Laboratory Reference Ranges for Local Laboratories in Clinical Research, DIA Journal (2012; in Press).
5. Mitchel, J., Schloss-Markowitz, J., Yin, H. et al. Lessons Learned From a Direct Data Entry (DDE) Phase 2 Clinical Trial Under a US IND. Drug Information Journal (2012 accepted for publication)