Health Decisions

Infobox Company
company_name = Health Decisions
company_
company_type = Contract Research Organization
foundation = 1989
location = Durham, NC, USA, Abingdon, Oxfordshire, UK
key_people = Michael Rosenberg, MD, MPH (CEO); Richard Farris (COO); Alicia Paladin, MBA, CPA (CFO); Gail O'Mullan, LLB (CPO)
products = adaptive clinical research; contract research services; drug development systems consulting
homepage = http://www.healthdec.com/

Health Decisions is a global, full-service CRO specializing in the development and application of adaptive systems and technologies to improve the efficiency of pharmaceutical research. [http://www.healthdec.com] It has won numerous awards including the Enterprise Value Award by CIO [ [http://www.cio.com/article/31679/Health_Decisions_Stands_Out_in_Pharmaceutical_Industry Health Decisions Stands Out in Pharmaceutical Industry - CIO.com - Business Technology Leadership ] ] , and has been awarded contracts by the National Institute of Child Health and Human Development to develop new contraceptives. [ [http://findarticles.com/p/articles/mi_pwwi/is_200402/ai_mark2065280535 Health Decisions Awarded NICHD Contract to Speed Contraceptive Development | Market Wire | Find Articles at BNET ] ]

The company utilizes advanced adaptive techniques, with proprietary technology and processes, to allow more effective management and strategic decision-making. Based on the principle of more information, of better quality, earlier in the process than is otherwise possible, the company stresses lessons from other industries notably continuous measurement and refinement. The company emphasizes application of adaptive principles in both the traditional design level (elements such as sample size re-estimation, seamless studies) as well as the operational level. As a service provider, Health Decisions stresses responsive, thoughtful service centered on individual needs.

Health Decisions’ systems provide continuous tracking of a broad range of performance metrics, from numerous operational details (such as enrollment strategy, screen failures, site performance, CRA productivity) to program-level strategic issues (dose defining, pruning, midcourse efficacy checks, portfolio management). This enables a high degree of management control, allowing studies to be done quicker and reducing or eliminating between-study gaps. Compared with current industry norms, this approach consistently produces results 25% or better, whether measured by budget, timelines, IRR, or NPV. [Schoenberger C. An Alzheimer's drug goes on trial. Forbes Mar 20, 2000 [www.forbes.com/forbes/2000/0320/6507094a.html] ]

Health Decisions offers a range of services, centering on full-service study and program planning, conduction, and reporting in phases I-IV. Since high-velocity research generally involves a process change and strategic questions as well as nuts-and-bolts operational issues, much of the company’s work begins with consulting on strategic adaptive elements, including regulatory implications.

History

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

Location

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

ervices

*Comprehensive project/program planning, implementation, and reporting
*Project Management
*Clinical Services & Medical Writing
*Data Management
*Biostatistics
*Quality Management & Regulatory Compliance
*Strategic Consulting

Technology

Health Decision's proprietary technology includes:
* [http://www.healthdec.com/technology/smart_pen/ SmartPen] - System for capturing, encoding, and transmitting CRF data.
* [http://www.healthdec.com/technology/smart_monitoring/ Smart Monitor] - System for tracking and allocating monitoring resources, tools for increasing SDV efficiency.
* [http://www.healthdec.com/technology/web_applications/web-dqs.php Web-DQS] - Web-based system for managing data queries.
* [http://www.healthdec.com/technology/web_applications/web-rand.php Web-RAND] - Web-based randomization tool.
* [http://www.healthdec.com/technology/web_applications/web-msl.php Web-MSL] - Secure web-based system for maintaining a Master Subject Log.

martPen 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.

mart 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

* [http://www.cio.com/article/31679/Health_Decisions_Stands_Out_in_Pharmaceutical_Industry 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 (three times).
*Deloitte & Touche Technology Fast 500 fastest growing technology-based companies, private or public, in the United States (three times).
*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 [http://www.healthdec.com/experience/ 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 Health
***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

ee also

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

References

External links

* [http://www.healthdec.com Health Decisions website]