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Overview | Vision and Mission | CPO Advantages | ALPHADAS^®
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For Sponsors: Services and Capabilities Experience and Volunteer Populations

For Volunteers: Customized Facilities Contact Information

• Request information about clinical trials at Comprehensive Phase One
• Information about clinical trials in general

Since 1994, Comprehensive Phase One™ (CPO) has been an organization committed to communication, partnership, and superior execution. As both the world of Phase 1 providers, as well as client needs grow increasingly complex, it is vital to engage with trusted experts to ensure timely, high-quality results - the clinical professionals at Comprehensive Phase One are such experts. As a fully integrated member of Comprehensive NeuroScience, CPO, provides both full service and clinical conduct offerings in Phase 1 to pharmaceutical and biotechnology companies, large and small. Staffed with experienced bilingual research professionals, CPO provides clients with quality data, rapid patient enrollment, and optimal medical coverage by an experienced, dedicated, round-the-clock research team.

Guiding Principles

• Subject safety always comes first
• The quality of our work is paramount
• Continuous improvement is the focus of everything we do
• We value our reputation in the industry
• We maintain extremely high standards of ethics and integrity
• We value the hard work and talent of our clinical research team

Vision. To advance medicine by reducing the time and expense of bringing new therapies to patients in need.

Mission

• For customers. To provide Best-in-Class quality Phase I services, exceeding expectations in both quality and productivity
• For study participants. To treat volunteers with the utmost dignity, courtesy, kindness and respect
• For employees. Offering healthy, challenging and satisfying work environment for all employees
• For the community. To provide a highly-credible, growing, dynamic business

Dedicated and Loyal Staff. CPO provides clients with a dedicated and experienced project leadership team. Miramar’s highly trained, licensed personnel is comprised of a dually board-certified, 'hands-on' Physician Investigator with nearly two decades in the industry, full-time clinic director, ACLS-certified nurses and paramedics, certified clinical research coordinators, pharmacists, dieticians and research technicians. More than 80% of CPO staff are bilingual, enabling proper care and communication with the multi-ethnic, diverse patient populations of South Florida. CPO boasts a low staff turnover rate across its 12 years of operation. With a strong commitment to training and a team-oriented environment, our loyal employees remain dedicated to our facility and to our clients. Collectively, we find this 'family' dedication, in addition to our high-quality results and open communication, to be a critical reason pharmaceutical companies regularly return to CPO for Phase 1 research.

Commitment to Quality. CPO is committed to ensuring patient safety while collecting high-quality data for our clients. All procedures and programs meet or exceed the standards of Good Clinical Practice (GCP). Furthermore, CPO standards augmented by CNS' parent standard operating procedures and on-going training programs for our staff, assures that we are compliant with evolving standards and regulations.

Strong Patient Recruitment and Retention. When it comes to enrollment, CPO consistently delivers on its promise. With 100% enrollment to goal and 96% completion rates across all Phase 1 studies, CPO has identified and implemented the elements key to recruitment and retention. Our extensive database represents a broad range of ages, disease indications, ethnicities, and other specialty populations, giving our clients ready access to qualified participants.

Advanced technology to benefit patients and sponsors. In Phase I research, rapid decision-making is commonplace, making access to real-time data critical to success. Implementation of the ALPHADAS system will make such access simple and reliable for clients, with a web-based interface providing customers with the opportunity to directly track recruitment, enrollment, and study conduct as well as obtain trial results immediately upon their availability on-line. Such capabilities allow for even more rapid sponsor review and input, particularly in the case of dose escalation and first–in-human trials.

Wide Range of Services and Capabilities. CPO has the ability to complete both short and long-term studies for small or large patient populations with a variety of requirements, from 12 hours to 120 days. By using advanced electronic systems for recruitment, data capture, tracking, and reporting (ALPHADAS in 2007) to simplify operations and give sponsors real-time on-line access to their study, CPO redefines integration as sponsors can experience CPO as an extension of their own internal resources.

CPO can fully manage both study and clinical conduct, including protocol writing, project management, monitoring, data management, PK analysis and statistics, as well as final report writing.

• 5,000 + study participant database
• 24-hour medical monitoring
• Bioanalytical Services
• Protocol Consultation and Writing
• CRF Design and Development
• PK/PD Analysis
• Data Collection, Management, and Analysis
• Report Writing

CPO has experience with a variety of study designs, including recent industry efforts in combining multiple objectives into a single program.

• First-in-Human
• Bioavailability/Bioequivalence
• Cardiac safety/Definitive QTc
  • Intensive Phase I ECG trials
  • PK/PD characterization of QTc
  • Drug interactions
  • Special populations
  • Single/multiple rising dosing
• Telemetry monitored
• Single and multiple dose pharmacokinetics-pharmacodynamics
• Food effect
• Drug interaction
• Single and Multiple Ascending Dose
• Frequent Sampling/Growth Hormone
• Bioavailability/Controlled Substances
• Age and gender

Wide Range of Experience and Volunteer Populations. CPO has experience with an extensive number of procedures and study requirements, working with many different volunteer populations.

CPO has experience with a variety of procedures, and study requirements.

• Device/Drug Delivery
• Intranasal Drug Delivery
• Transdermal Drug Delivery
• IV Infusion Drug Delivery
• Special Laboratory Processing Techniques
• Multiple Electrocardiograms
• Multiple-day, 24-hour Urine and Blood Collections
• Glucose Monitoring Devices
• Telemetry - Holter monitoring
• Ultrasound
• Mammograms
• Bone Densitometry
• Biopsy requirements

CPO has experience with a variety of volunteer populations, including local relationships to achieve recruitment goals for renal or hepatic impairment studies.

• Healthy Adults
  • Healthy male and female subjects
  • Postmenopausal subjects
  • Healthy Elderly Males and Females
  • Obesity – Overweight subjects
  • Healthy Young Females on Oral Contraceptives
    
• Illness-based populations
  • Type 1 and 2 Diabetes
  • Hyperlipidemia and Dyslipidemia
  • Hypertension
  • Renal Impairment
  • Hepatic Impairment
  • Rheumatoid Arthritis
  • Respiratory Disease (COPD)
  • Hypogonadal Males
    

Our newly constructed research facility provides a high level of security and comfort for our study participants. The airy, light environment, kitchen facilities, and recreation room also contribute to patient retention. The facility also features state-of-the-art equipment and a customized laboratory enabling us to offer the most advanced medical technology and care. This new center in Miramar includes:

• 46,000 square feet
• 120 beds
• 12-bed telemetry unit
• Outpatient treatment center
• Secured, environmentally controlled pharmacy
• Private monitor offices
• Secured, controlled access to facility
• Video surveillance
• Locked refrigerators and freezers (-20°, -70°, -80°)

In its short move from Fort Lauderdale to Miramar, CPO listened closely to feedback from volunteers in designing its new facility. With over 46,000 square feet, CPO Miramar includes ample space for volunteers and amenities such as large recreational and dining areas. View a photo album of the Miramar facility.

To learn more about Comprehensive Phase One, please call the following numbers:

For Study Participants:

For Sponsors:

• Directions to CNS-CPO Bradenton: Business Development for CNS
• Directions to CNS-CPO Miramar: Clinical Facility
• Directions to CNS- CPO Fort Myers: Clinical Facility