Exceptional CRO Services That Meet Your Needs

As a full-service CRO, we are dedicated to meeting the clinical development needs of biotechnology, pharmaceutical and medical device companies, at all stages of development. Our reputation for quality, responsiveness, and flexibility is based on more than 13 years of clinical research experience. Our services are always tailored to meet the specific needs of each study. Working closely with you as part of your team, we share your work and share your vision!

Our clinical service capabilities include:

Project Management

• Study management in the US, Europe, Eastern Europe, India, Australia/New Zealand,
  and Latin America
• Program planning and implementation
• Recruitment and retention
• Secure access to study data

Clinical Applications

• Project tracking and management
  
• Flexible data management
  
• Electronic medical and safety reports
  
• Real-time reporting

Clinical Operations

• Investigator recruitment
• Study start up / Regulatory document management
• Monitoring (site qualification to close-out)
• Site management

IVRS/IWRS

• Web-based or telephone (IVRS – Interactive Voice Response System)
• Randomization – schedule or dynamic
• Patient diaries
• Drug inventory control

Data Management

• EDC – electronic data capture (SynCapture™)
• Fax-based data collection (Clinical DataFax®)
• Paper-based data collection (Clintrial®)

Medical and Regulatory Affairs

• Strategic planning for medical oversight
• Medical monitoring
• Safety surveillance – SAE management / Regulatory reporting
• Oracle AERS® hosting
• Medical terminology coding (SynCoder™ )
• Medical writing
• E2B Gateway for electronic submission

Biostatistics

• Statistical planning and study design
• Study randomization
• Expert data analysis
• CDISC conversion
• Data integration – ISS/ISE
• Data monitoring committee
• Data browse/Query (Integrated Review™ )

IT Services

• DataFax consulting
• Validation services
• Oracle AERS® hosting
• IVRS/IWRS