ORCA's employs a combination of in-house and regional staff of experienced and skilled personnel. This allows us to offer you the best possible combination of service and price tailored to your company-specific needs. ORCA also understands that conducting a clinical study is not only a "formula-based" process. Our decades of real-world experience have enabled us to develop a responsive process which we call "Intelligent Monitoring." We know that not all sites will require the same level of monitoring to reach your required standard of performance. Our staff is trained to evaluate the critical factors at each site and provide the appropriate level of attention to train the staff and ensure adherence to the protocol. Rather than monitoring on a tight schedule which can create unnecessary cost to you and stress on the clinics, our monitors determine the most efficent timing to monitor the study at each clinic. The services provided by the ORCA Clinical Operations Staff include, but are not limited to:

  • Clinical Trial Management and Operations
  • Project Management
  • Site Management
  • Clinical Monitoring
  • GCP development to Medical Device or ICH Standards
  • Investigator Recruitment
  • Collection of existing OUS clinical data to support FDA submissions
  • Patient Recruitment/Retention
  • Randomization Services
  • Case Report Form Design
  • Informed Consent Form development
  • IRB applications
  • Negotiation of Site Contracts
  • Investigator Agreements and FDA Form 1572/1573
  • Financial Disclosure Documents

Additional services available from our affiliated partners

  • Biostatistics
  • SAS Programming
  • Medical Writing