Method
Communication as Part of the Ockham Method
Ockham applies collaborative processes to ensure effective interaction with the project Sponsor. Understanding that effective communication doesn’t happen in a vacuum, Ockham takes a proactive approach to management, coupling it with scientific and operational expertise to elicit the most successful outcome for the trial. Ockham collaborates closely with the Sponsor to generate a robust Communication Plan that promotes regular, interactive communication and quality deliverables at every phase of the trial.
Status Reports and Timeline Reviews
At regular points in the timeline, Ockham interacts with the Sponsor to maximize effective communications through the submission of Status Reports and Timeline Reviews. Delivered by Ockham’s Project Manager on a monthly basis throughout the project, these reports serve as concise summaries of work accomplished. In addition, Ockham’s Project Manager also develops and provides a detailed project timeline to track the progress of the study.
Process Troubleshooting
At Study Start-Up – and indeed, even before the project starts – Ockham’s technical and operational experts examine all aspects of the study to identify, isolate, and prevent potential issues.
Steering Committee
The Steering Committee meets each week during Study Start-Up, bi-weekly during Enrollment, and weekly during Study Close-Out to conduct Gap Analysis. These problem-solving sessions focus on site-related issues (e.g., delays), enrollment (e.g., slow enrollment), or availability/shipment issues related to study drug. This group may also review other matters relevant to the project such as resource allocation, resourcing, conduct Protocol or Financial (budget to actual) assessments, or conduct Quality (Site/Vendor Audits) or Regulatory reviews.
Gap Analysis
Ockham applies Gap Analysis and other proven problem-solving techniques to resolve any potential issues that have been identified. At each step, Ockham programs regular senior-level consultations with the Sponsor. Simultaneously, appropriate Ockham managers actively review the project’s resource and resourcing elements, assess the protocol, execute due diligence on financials (budget to actual), perform careful quality and regulatory reviews – and communicate them to the Sponsor to elicit feedback.
Meetings
Regular Weekly Meetings (teleconferences) typically lasting one hour are held during Study Start-Up (twice monthly during Enrollment, Treatment, and Close-Out), and are attended by key operational leads.
Internal Project Meetings are scheduled twice monthly so that the Project Team can discuss issues and planning, face-to-face.
