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Clinical Research

Full-Service e*CRO

Target Health, LLC

is committed, through creative collaboration, to serve the pharmaceutical community with knowledge, experience, technology and connectivity. 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.

The Clinical and Scientific Affairs Department

Where Science Drives Medical Research

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Creative Collaboration

Whether assuming full project management or as a supportive adjunct to your project management team, Target Health’s Clinical Research team will do all in its power to ensure the success and to sustain the momentum of your project.

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Expertise

Our seasoned clinical research team has over 150 years of collective international and US experience in Phase I – IV clinical trial management including pharmaceuticals, biologics, and devices. The project team will bring a personal and sponsor-focused goal-driven approach to meet project milestones. Tenure and stability are hallmarks of the clinical research team. The majority of the team have been with Target Health for greater than 8 years (range: 1 to 17 years).

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Leadership

This team has pioneered the implementation of innovative tools and practices in risk-mitigation strategies, risk-based monitoring, Direct Data Entry, and e-Informed consents. Our monitors are highly skilled in remote data review, identification of trends, and new “outside of the box” approaches to site management and data review.

Technological Innovation

Project managers work directly with data management to create system-generated data cleaning that is intuitive and protocol-driven leading to real-time data cleaning and reductions in on-site monitoring requirements and time to data-base lock..

  • Integrated pharmacovigilance, IMP management, investigator payments
  • Real-time review of clinical data through Direct Data Entry and remote data monitoring
  • Electronic source data (e*CTR) reduces time spent in on-site source data review
  • Electronic Informed Consents attenuate consenting errors and allow remote review
  • Seasoned monitors skilled in on-site and remote data review
  • Use of targeted reports to identify data errors, trends, and to facilitate early data correction
  • Partnering with preferred 3rd party vendors with direct data input into the eCRF from smart devices, tablets, ePRO, SmartBands, etc.
  • Development and implementation of electronic Trial Master File for all regulatory and essential study documents at the sponsor, study, and site level.

Teamwork

  • Effective communication with our partners through meeting management and study-related plans, utilizing available venues such as in person meetings and via internet and telephone
  • Quality by Design planning with our partners on protocol-driven risk assessment and mitigation
  • Operationalizing risk-based monitoring strategies with seasoned Project Managers, Clinical Research Associates and Clinical Operations Specialists with our partners.

Medical Writing

  • Supporting scientific, clinical and regulatory documentation
  • Literature reviews
  • Writing, editing, reviewing and publishing:
    • Study Results
    • Clinical Study Reports
    • Protocols
    • Investigator Brochures
    • Informed Consents