Clinical Management

With all the challenges involved in executing rare disease clinical trials, your study’s success depends on the support of an outstanding clinical team. Our clinical project management team is highly trained and have significant experience – and passion – in rare disease. Our experienced Project Managers provide strategic actions throughout the entire project cycle to help ensure your project’s success. We understand how critical it is to get the project running quickly and efficiently and it’s our focus to provide an organized and thoughtful approach to each project. Communication throughout the study is essential to building a successful partnership.

At Orphanos, we offer a Clinical Trial Management System so that up to the minute information can be shared across all functions of all departments within the Sponsor-CRO team 24 hours a day. We are committed to maintaining a high level of communication with our clients and we promise full transparency and quality throughout each study. We have the phase I – IV experience and a team that you can trust.

Orphanos is a full-service clinical CRO specializing in clinical trial management and patient recruitment in orphan drug and rare disease trials.

Our services include:

  • Site selection focused on highly engaged sites with an appropriate and relevant patient population
  • Negotiation of clinical trial agreements
  • Investigator meeting management and administration of investigator payments
  • Development of presentations, meeting materials, and a professional study brand
  • Protocol development including facilitating the review process with all key contributors
  • Specialized site management with an emphasis on reinforcing key product messages and managing commercially sensitive investigator relationships
  • Create and maintain study documents
  • Commercially sensitive project management characterized by:
    • A partnership-based approach featuring close contact with key study team personnel
    • Open communication through ongoing availability via phone or email, study reports, and ad hoc update meetings and reports
    • Team based approach to management from the project managers, CRAs and monitors
    • A focus on continuing education for all team members to ensure the most effective technology and concepts are applied
    • Clinical monitoring for all types of visits worldwide
    • Work directly with sponsor’s data management team for preferred outsourced company
  • Commitment to quality assurance throughout the life of the trial, including implementation of a Quality Management Plan on every trial, routine internal audits, SOP training and adherence, and ongoing GCP/ICH training for all project team members