Health Decisions

Health Decisions is a contract research organization located in Chapel Hill, North Carolina. It has developed a number of proprietary technologies related to clinical research including the SmartPen system for electronic data capture and secure transmission, web application services for trial management, and Smart Monitor for trial monitoring.

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History

Health Decisions was founded by Dr. Michael Rosenberg in 1989.

Location

Health Decisions has main offices in Chapel Hill, North Carolina, USA, and in Abingdon, Oxfordshire, UK.

Services

• Project Management
• Clinical Services & Medical Writing
• Data Management
• Biostatistics
• Quality Management & Regulatory Compliance
• Strategic Consulting

Technology

Health Decision's proprietary technology includes:

• SmartPen™ - System for capturing, encoding, and transmitting CRF data.
• Smart Monitor™ - System for monitoring and analyzing clinical site activity.
• Web-DQS™ - System for resolving queries.
• Web-RAND™ - Randomization tool.
• Web-MSL™ - Secure web-based system for maintaining a Master Subject Log.

SmartPen System

Rather than using only paper-based case report forms (CRFs) or web-based terminal entry systems, Health Decisions uses the SmartPen to digitally capture pen strokes on the paper CRFs. The digitized CRFs are then transmitted via a docking station to Health Decisions and can be compared to the paper CRFs for validation. The ability to use a pen to record patient data and have it available immediately after docking the pen is unique in the industry of clinical research.

Web-DQS

Web-DQS is a web-enabled Data Query System designed to resolve queries for CRFs.

Users select from a query options box to access and view queries for their site by subject number and query status. When a query is selected, the user sees both the specific unresolved question and the form for answering the query by inserting missing data, correcting faulty data or indicating the data discrepancy is irreconcilable. Web-DQS then immediately returns the "form" to the database for processing, ensuring the information is available in real-time.

Both site monitor and administrative personnel with the proper permissions can access Web-DQS to resolve a query or check its status. The system can generate "alerts and reminders" to monitors and investigators, enhancing communication, maximizing data quality, and facilitating site evaluation.

Smart Monitor

Smart Monitor is a series of tools and processes developed by Health Decisions to remotely track clinical site activity and progress to increase site monitoring efficiency. These tools track site metrics such as patient enrollment and treatment efficacy, and display these data on a study website. They also allow source document verification on a remote site-specific study database.

Through this type of remote monitoring problems with the study can be identified and resolved more efficiently, and the study sponsor can be kept more up to date with study progress. Typical issues that remote monitoring can assist with include: poor patient enrollment rates, determining whether to continue the study based on efficacy results, a site or study demanding a significant amount of monitoring time, and deciding whether or not to drop a site due to poor communication or performance quality. The alternative to this type of smart monitoring entails waiting for digital or paper copies to reach the CRO, and the sponsor then waiting for this data to be processed and made available to them. Via smart monitoring data can be made available more quickly, and decisions about the study made faster, and on-site monitoring time can be reduced.

Awards

• CIO Enterprise Value Award recognizes only five companies worldwide whose innovation in technology provides the ability to substantially improve the way companies operate.
• Cisco Growing With Technology Award presented to the 50 US companies with the most innovative use of technology that results in measurable improvement in business process development.
• Inc 500 fastest growing private companies in the United States.
• Deloitte & Touche Technology Fast 500 fastest growing technology-based companies, private or public, in the United States.
• Ernst & Young Entrepreneur of the Year Award - Health Sciences Division recognizes the most successful and innovative entrepreneurs strive for the most prestigious honor in their respective divisions.

Therapeutic Domains

Health Decisions has therapeutic experience in the following areas (obtained from this section of Health Decision's website):

• Infectious diseases
  • HIV/AIDS
  • STDs
  • Antibiotics
  • Antifungals
• Cardiovascular
• Oncology
  • Breast cancer
  • Renal
  • Prostatic
• Dermatology
• Devices
• Endocrine-Metabolism
  • Diabetes
  • Growth hormone
  • Obesity
  • Acromegaly
• Renal
  • Hemodialysis
  • CKD
• Emergency medicine
• Gastroenterology
  • Ulcerative colitis
  • Crohn's disease
• Reproductive Health
  • Women's Heatlh
    • HRT
    • Sexual dysfunction
    • Contraceptives
    • Obstetrics
    • HRT
    • Dysmenorrhea
  • Men's Health
    • Erectile dysfunction
    • PIN
    • Contraception
• Respiratory
• Wound healing
• Vaccines
• Psychiatry
  • Antidepressants
• CNS
  • Alzheimer's
  • MCI
• Vaccines
• OTC products
• Pharmacoeconomics

See also

• Contract Research Organization
• Electronic Data Capture
• Clinical trial
• Clinical data acquisition
• Clinical data management system