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, staffing, 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 staffing 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.