October 30, 2017What's New
From time to time we are asked What is Target Health and What Do You Do? So those of you not familiar with our services, here they are.
Target Health Inc., a full-service e*CRO, is committed, through creative collaboration, to serve the pharmaceutical community with knowledge, experience, technology and connectivity. Our goal is to get products to the market to help those in need. Our pledge is to optimize the life cycle of drugs, biologics and devices with expertise, leadership, innovation and teamwork. We provide superior, consistent performance with a cutting edge, diverse team with the highest standards of ethical conduct and integrity.
Our team is both home-grown and from the Industry, with many of our employees have been with us for 10, 15 and yes, some just about 20 years. Our industry-based employees come from Amgen, Boehringer Ingelheim, Certara, Eisai, Microsoft, NY Blood Center, Pfizer, Quintiles, Regeneron, Sanofi, Siemans, Wyeth, etc.
We have been inspected twice by FDA as part of 2 pre-approval inspections with no 483 findings. Here is an excerpt: This inspection is a part of FDA's Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to ensure that the rights, safety, and welfare of the human subjects of those studies have been protected. From our evaluation of the establishment inspection report and the documents submitted with that report, we conclude that you adhered to the applicable statutory requirements and FDA regulations governing the monitoring practices of clinical investigations and the protection of human subjects.
Our services, in alphabetical order, include:
Biostatistics: Led by Leigh Ren, we provide full Biostatistical services including statistical planning, randomization codes, protocol statistical sections, SAPs, TLF's, statistical reports, etc.
Clinical Research: Led by Dave Luke, we manage full paperless clinical programs using top PMs from the industry. We also prepare clinical study reports (CSRs) and prepare manuscripts. Examples of current and past programs include, autism, ADHD, epilepsy, psychiatry, male health, emergency contraception, head lice, periodontal disease, studies in the newborn, etc.
Data Management: Led by Yong Joong Kim, we provide full DM services, fully integrated with Target e*CRF®, Data Management plans, DM review during the clinical trial, clean file meetings, CRF annotation, integration with external labs, SDTM mapping, etc.
EDC: Led by Joonhyuk Choi, we provide full EDC application services at one website and no required devices. We use Target e*Studio® to build Target e*CRF applications, including on line randomization, direct data entry at the time of patient encounter (Target e*CTR® ; eClincal Trial Record), ePRO, eCOA, management and risk-based monitoring reports, drug supply management, SAE management, onsite and remote monitoring reports, etc.
Regulatory Affairs: Led by Mary Shatzoff, we provide strategic planning and regulatory operations services for more than 55 companies. We initiate, coordinate and manage FDA meetings and interactions, and provide paperless regulatory submissions via FDA's Gateway. Examples of key FDA approvals where we made a difference include, Gaucher Disease, Emergency Contraception, Head Lice, In Vitro Fertilization, Prostate Cancer, Periodontal Disease, Adhesion Prevention in Cardiac Surgery in the Newborn, Urology, Hair Loss in Cancer Chemotherapy, Bone Fracture Healing, etc.
Software Development: Led by Les Jordan, the next version of Target e*Studio will allow almost anyone with clinical research experience, to rapidly create and deploy the cost-effective clinical trial of the future, including but not limited to, online randomization, eSource, and full integration with the EHR, mobile devices, telemedicine, etc.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor